Clincosm LogoSign in Get a demo

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04292899
Collaborator
(none)
4,891
Enrollment
183
Locations
4
Arms
3.8
Actual Duration (Months)
26.7
Patients Per Site
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
4891 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19
Actual Study Start Date :
Mar 6, 2020
Actual Primary Completion Date :
Apr 9, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Remdesivir (RDV), 5 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

Drug: Remdesivir
Administered as an intravenous infusion
Other Names:
  • GS-5734™
  • Veklury®

    • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
    Experimental: Part A: Remdesivir, 10 Days

    Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

    Drug: Remdesivir
    Administered as an intravenous infusion
    Other Names:
  • GS-5734™
  • Veklury®

    • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
    Experimental: Part B: Remdesivir, 10 Days (Extension)

    Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.

    Drug: Remdesivir
    Administered as an intravenous infusion
    Other Names:
  • GS-5734™
  • Veklury®

    • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
    Experimental: Part B: Remdesivir 10 days (Mechanically Ventilated)

    Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10

    Drug: Remdesivir
    Administered as an intravenous infusion
    Other Names:
  • GS-5734™
  • Veklury®

    • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 [Day 14]

      Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.

    Secondary Outcome Measures

    1. Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [First dose date up to last dose date (maximum: 10 days) plus 30 days]

      Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to < 18, where locally and nationally approved) prior to performing study procedures

    • Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))

    • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization

    • Currently hospitalized

    • Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening

    Key Exclusion Criteria:

    • Participation in any other clinical trial of an experimental treatment for COVID-19

    • Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing

    • Evidence of multiorgan failure

    • Mechanically ventilated [including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.

    • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)

    • Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of age

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue Anaheim California United States 92806
    2 Alta Bates Summit Medical Center Berkeley California United States 94609
    3 Mills-Peninsula Medical Center Burlingame California United States 94010
    4 Eden Medical Center Castro Valley California United States 94546
    5 Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway Downey California United States 90241
    6 Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave Fontana California United States 92335
    7 St Joseph Hospital Eureka Fortuna California United States 95540
    8 Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave. Harbor City California United States 90710
    9 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    10 Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave. Los Angeles California United States 90034
    11 Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue Los Angeles California United States 91365
    12 Mission Hospital Regional Medical Center Mission Viejo California United States 92691
    13 Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue Moreno Valley California United States 92555
    14 El Camino Hospital Mountain View California United States 94040
    15 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92658
    16 Kaiser Permanente Oakland Medical Center Oakland California United States 94611
    17 Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue Ontario California United States 91761
    18 The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange Orange California United States 92868
    19 Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street Panorama City California United States 91402
    20 Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue Riverside California United States 92505
    21 Sutter Medical Center Sacramento, One Medical Plaza Roseville California United States 95661
    22 Sutter Medical Center Sacramento Sacramento California United States 95815
    23 Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue San Diego California United States 92120-2507
    24 Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd San Diego California United States 92123
    25 Kaiser Permanente Oakland Medical Center, 1200 El Camino Real San Francisco California United States 94080
    26 California Pacific Medical Center-Infectious Disease Associates Medical Group San Francisco California United States 94109
    27 Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd San Francisco California United States 94115
    28 Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850 San Jose California United States 95119
    29 Kaiser Permanente Oakland Medical Center, 2500 Merced St San Leandro California United States 94577
    30 Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway Santa Clara California United States 95051
    31 Providence St. Johns Medical Center Santa Monica California United States 90404
    32 Sutter Santa Rosa Regional Hospital Santa Rosa California United States 95403
    33 Stanford Hospital Stanford California United States 94305
    34 University of Colorado Denver, University of Colorado Hospital Aurora Colorado United States 80045
    35 SCL Health St. Joseph Hospital, 1375 East 19th Ave Denver Colorado United States 80208
    36 SCL Health St. Joseph Hospital Denver Colorado United States 80218
    37 Rose Medical Center Denver Colorado United States 80220
    38 SCL Health St. Joseph Hospital, 200 Exempla Circle. Lafayette Colorado United States 80026
    39 Yale-New Haven Hospital New Haven Connecticut United States 06510
    40 Kaiser Permanente Hawaii Moanalua Medical Center Honolulu Hawaii United States 96819
    41 John H. Stroger Jr. Hospital of Cook County Chicago Illinois United States 60612
    42 Rush University Medical Center Chicago Illinois United States 60612
    43 University of Chicago Chicago Illinois United States 60637
    44 IU Health Methodist Hospital Indianapolis Indiana United States 46077
    45 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    46 Tulane University New Orleans Louisiana United States 70112
    47 Maine Medical Center Portland Maine United States 04102
    48 Holy Cross Hospital Silver Spring Maryland United States 20910
    49 Tufts Medical Center Boston Massachusetts United States 02111
    50 Brigham & Women's Hospital and Harvard Medical School Boston Massachusetts United States 02115
    51 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    52 The University of Michigan Hospitals and Health Systems Ann Arbor Michigan United States 48109-5378
    53 Henry Ford Health System Detroit Michigan United States 48202
    54 Hennepin Healthcare Minneapolis Minnesota United States 55415
    55 Mayo Clinic Rochester Minnesota United States 55905
    56 Providence St Patrick Hospital and International Heart Institute of MT Foundation Missoula Montana United States 59802
    57 Darmouth-Hitchhock Medical Center Lebanon New Hampshire United States 03756
    58 Hackensack University Medical Center Hackensack New Jersey United States 07601
    59 Robert Wood Johnson University Hospital Somerset Hillsborough New Jersey United States 08844
    60 Robert Wood Johnson University Hospital Somerset, 1 RWJ Place New Brunswick New Jersey United States 08901
    61 Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue Newark New Jersey United States 07112
    62 St. Joseph's University Medical Center Paterson New Jersey United States 07503
    63 Jacobi Medical Center Bronx New York United States 10461
    64 James J. Peters Veterans Administration Medical Center Bronx New York United States 10468
    65 Jamaica Hospital Medical Center Jamaica New York United States 11418
    66 Danbury Hospital Lagrangeville New York United States 12540
    67 North Shore University Hospital Manhasset New York United States 11030
    68 North Shore University Hospital, 270-05 76th Ave New Hyde Park New York United States 11040
    69 Icahn School of Medicine at Mount Sinai, 350 East 17th Street New York New York United States 10003
    70 Icahn School of Medicine at Mount Sinai, 1000 10th Avenue New York New York United States 10019
    71 Icahn School of Medicine at Mount Sinai, 440 West 114th St. New York New York United States 10025
    72 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    73 Columbia University Medical Center-New York Presbyterian Hospital New York New York United States 10032
    74 New York Presbyterian Hospital/Weill Cornell Medical Center New York New York United States 10065
    75 Duke University Medical Center Durham North Carolina United States 27710
    76 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    77 Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave Hillsboro Oregon United States 97124
    78 Providence Portland Medical Center Portland Oregon United States 97213
    79 Providence St. Vincent Medical Center Portland Oregon United States 97225
    80 Kaiser Sunnyside Medical Center Portland Oregon United States 97227
    81 Hospital of the University of Pennsylvania, 51 N. 31st Street Philadelphia Pennsylvania United States 19104
    82 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    83 Temple University Hospital Philadelphia Pennsylvania United States 19140
    84 The Miriam Hospital Providence Rhode Island United States 02906
    85 Prisma Health Richland Hospital Columbia South Carolina United States 29203
    86 Prisma Health Richland Hospital, 701 Grove Road Greenville South Carolina United States 29605
    87 The Liver Institute of Methodist Dallas Medical Center Dallas Texas United States 75203
    88 UT Southwestern Medical Center Amelia Court, HIV Research Clinic Dallas Texas United States 75235
    89 Baylor University Medical Center Dallas Texas United States 75246
    90 UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd. Dallas Texas United States 75390
    91 UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd Dallas Texas United States 75390
    92 Baylor University Medical Center, 1400 8th Ave Fort Worth Texas United States 76104
    93 Houston Methodist Hospital Houston Texas United States 77030
    94 Baylor University Medical Center, 2401 S. 31st St. Temple Texas United States 76508
    95 University of Utah Health Salt Lake City Utah United States 84132
    96 Virginia Hospital Center Arlington Virginia United States 22205
    97 Inova Fairfax Medical Campus Falls Church Virginia United States 22042
    98 VCU Health Medical Center Richmond Virginia United States 23298
    99 Providence Regional Medical Center Everett Everett Washington United States 98201
    100 Kadlec Regional Medical Center Kennewick Washington United States 99336
    101 Providence St. Peter Hospital Olympia Washington United States 98506
    102 Virginia Mason Medical Center Seattle Washington United States 98101
    103 Swedish Center for Comprehensive Care Seattle Washington United States 98104
    104 MultiCare Deaconess Hospital Spokane Washington United States 99204
    105 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    106 St Joseph Medical Center Tacoma Washington United States 98405
    107 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China
    108 CHU Pellegrin Bordeaux France 33076
    109 CHU de Montpellier-Hopital Gui de Chauliac Montpelier Cedex 5 France 34295
    110 CHU de Nantes-Hotel Dieu Nantes France 44035
    111 Hopital Saint-Louis Paris France 75010
    112 Hopital Saint Antoine Paris France 75012
    113 Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie Berlin Germany 13353
    114 Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie Düsseldorf Germany 40225
    115 Universitatsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    116 Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany 24105
    117 Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie Leipzig Germany 4129
    118 Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2 Munich Germany 81675
    119 Klinik für Hämatologie, Onkologie, Immunologie München Germany 80804
    120 Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP) Stuttgart Germany 70376
    121 Prince of Wales Hospital Hong Kong Hong Kong
    122 Princess Margaret Hospital Hong Kong Hong Kong
    123 Queen Mary Hospital Hong Kong Hong Kong
    124 UOC Malattie Infettive, ASST Papa Giovanni XXIII Bergamo Italy 24127
    125 ASST degli Spedali Civili di Brescia Brescia Italy 25123
    126 ASST di Cremona - Azienda Socio Sanitaria Territor Cremona Italy 26100
    127 UOC Malattie Infettive, IRCCS Ospedale San Raffaele Milano Italy 20127
    128 Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco Milano Italy 20157
    129 UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy 20122
    130 UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova Padova PD Italy 35121
    131 Azienda Ospedaliero Universitaria di Parma Parma Italy 43126
    132 UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo Pavia Italy 27100
    133 Ospedale Guglielmo da Saliceto AUSL di Piacenza Piacenza Italy
    134 UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S. Roma Italy 00149
    135 Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia Torino Italy 10149
    136 Yokohama Municipal Citizen's Hospital Kanagawa Japan 240-8555
    137 Nagoya City East Medical Center Nagoya Japan 464-8547
    138 Tokyo Metropolitan Bokutoh Hospital Tokyo Japan 130-8575
    139 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    140 Seoul Medical Center Seoul Korea, Republic of 02053
    141 National Medical Center Seoul Korea, Republic of 04564
    142 Amsterdam University Medical Centre - Location AMC Amsterdam Netherlands 1105 AZ
    143 Leiden University Medical Center Leiden Netherlands 2300 RC
    144 Erasmus Medical Centre Rotterdam Netherlands 3015 GD
    145 National University Hospital Singapore Singapore 119228
    146 Singapore General Hospital Singapore Singapore 169856
    147 National Centre for Infectious Diseases, Tan Tock Seng Hospital Singapore Singapore 308442
    148 Hospital Principe de Asturias Alcalá De Henares Madrid Spain 28805
    149 Complejo Hospitalario Universitario A Coruña A Coruña Spain 15006
    150 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    151 Hospital Universitari de Bellvitge Barcelona Spain 08907
    152 Hospital Clinic de Barcelona Barcelona Spain 8036
    153 Hospital Universitario Cruces Bizkaia Spain 48903
    154 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    155 Hospital Universitario Fundación Jiménez Díaz Madrid Spain 28040
    156 Hospital Universitario 12 de Octubre Madrid Spain 28041
    157 Hospital Universitario La Paz Madrid Spain 28046
    158 Hospital Regional Universitario de Málaga Málaga Spain 29010
    159 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    160 Sahlgrenska University Hospital, Ostra Gothenburg Sweden 41685
    161 SUS (Skanes University Hospital) Malmo Sweden 20502
    162 Karolinska University Hospital Stockholm Sweden SE-141 86
    163 Hopitaux Universitaires de Genève Genève 14 Switzerland 1211
    164 Ospedale Regionale di Locarno La Carità Lugano Switzerland CH- 6900
    165 Universitätsspital Zürich Zürich Switzerland 8091
    166 Kaohsiung Veterans General Hospital Kaohsiung Taiwan 81362
    167 China Medical University Hospital Taichung Taiwan 40447
    168 National Taiwan University Hospital Taipei City Taiwan 10002
    169 Imperial College Healthcare NHS Trust London Greater London United Kingdom W2 1NY
    170 Royal Infirmary of Edinburgh Edinburgh United Kingdom EH4 2XU
    171 Queen Elizabeth University Hospital Glasgow United Kingdom G51 4TF
    172 Hull University Teaching Hospitals NHS Trust Hull United Kingdom HU16 5JQ
    173 Royal Lancaster Hospital Lancaster United Kingdom LA1 4RP
    174 Liverpool University Hospital Liverpool United Kingdom L7 8XP
    175 Northwick Park Hospital London United Kingdom HA1 3UJ
    176 Royal Free London NHS Foundation Trust London United Kingdom NW3 2QG
    177 King's College Hospital NHS Trust London United Kingdom SE5 9RS
    178 University College London London United Kingdom WC1E 6JF
    179 Manchester University NHS Foundation Trust Manchester United Kingdom M13 9WL
    180 Manchester University NHS Foundation Trust Manchester United Kingdom M23 9LT
    181 Pennine Acute Hospitals NHS Trust Manchester United Kingdom M8 5RB
    182 Derriford Hospital Plymouth United Kingdom PL6 8BG
    183 Sheffield Teaching Hospitals Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04292899
    Other Study ID Numbers:
    • GS-US-540-5773
    • 2020-000841-15
    • ISRCTN15874265
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Remdesivir

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in the United States, Europe, and Asia. The first participant was screened on 06 March 2020. The last study visit occurred on 30 June 2020.
    Pre-assignment Detail 4958 participants were screened. 4891 participants were enrolled. 4 participants in Part A and 49 participants in Part B did not receive treatment and are not included in the analyses.
    Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group)
    Arm/Group Description Participants received continued standard of care (SOC) therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    Period Title: Overall Study
    STARTED 200 197 844 3597
    COMPLETED 168 164 621 2952
    NOT COMPLETED 32 33 223 645

    Baseline Characteristics

    Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group) Total
    Arm/Group Description Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Total of all reporting groups
    Overall Participants 200 197 844 3597 4838
    Age, Customized (Count of Participants)
    < 65
    116
    58%
    113
    57.4%
    581
    68.8%
    2399
    66.7%
    3209
    66.3%
    ≥ 65
    84
    42%
    84
    42.6%
    263
    31.2%
    1198
    33.3%
    1629
    33.7%
    Sex: Female, Male (Count of Participants)
    Female
    80
    40%
    64
    32.5%
    312
    37%
    1351
    37.6%
    1807
    37.4%
    Male
    120
    60%
    133
    67.5%
    532
    63%
    2246
    62.4%
    3031
    62.6%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    2
    1%
    0
    0%
    5
    0.6%
    40
    1.1%
    47
    1%
    Asian
    20
    10%
    25
    12.7%
    88
    10.4%
    313
    8.7%
    446
    9.2%
    Black
    21
    10.5%
    23
    11.7%
    149
    17.7%
    611
    17%
    804
    16.6%
    Native Hawaiian or Pacific Islander
    1
    0.5%
    0
    0%
    11
    1.3%
    29
    0.8%
    41
    0.8%
    White
    142
    71%
    134
    68%
    376
    44.5%
    1915
    53.2%
    2567
    53.1%
    Not Permitted
    0
    0%
    5
    2.5%
    56
    6.6%
    179
    5%
    240
    5%
    Other
    14
    7%
    10
    5.1%
    159
    18.8%
    510
    14.2%
    693
    14.3%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    47
    23.5%
    38
    19.3%
    328
    38.9%
    1341
    37.3%
    1754
    36.3%
    Not Hispanic or Latino
    152
    76%
    150
    76.1%
    478
    56.6%
    2123
    59%
    2903
    60%
    Not Permitted
    1
    0.5%
    9
    4.6%
    37
    4.4%
    129
    3.6%
    176
    3.6%
    Missing
    0
    0%
    0
    0%
    1
    0.1%
    4
    0.1%
    5
    0.1%
    Region of Enrollment (Count of Participants)
    United States
    118
    59%
    111
    56.3%
    722
    85.5%
    2927
    81.4%
    3878
    80.2%
    Spain
    31
    15.5%
    30
    15.2%
    27
    3.2%
    134
    3.7%
    222
    4.6%
    Italy
    39
    19.5%
    38
    19.3%
    16
    1.9%
    108
    3%
    201
    4.2%
    United Kingdom
    0
    0%
    0
    0%
    33
    3.9%
    144
    4%
    177
    3.7%
    Sweden
    0
    0%
    0
    0%
    5
    0.6%
    83
    2.3%
    88
    1.8%
    Singapore
    1
    0.5%
    8
    4.1%
    7
    0.8%
    44
    1.2%
    60
    1.2%
    Switzerland
    0
    0%
    0
    0%
    13
    1.5%
    44
    1.2%
    57
    1.2%
    Netherlands
    0
    0%
    0
    0%
    2
    0.2%
    45
    1.3%
    47
    1%
    Germany
    3
    1.5%
    1
    0.5%
    12
    1.4%
    27
    0.8%
    43
    0.9%
    France
    0
    0%
    0
    0%
    2
    0.2%
    25
    0.7%
    27
    0.6%
    South Korea
    6
    3%
    6
    3%
    0
    0%
    10
    0.3%
    22
    0.5%
    Hong Kong
    2
    1%
    2
    1%
    2
    0.2%
    0
    0%
    6
    0.1%
    Japan
    0
    0%
    0
    0%
    1
    0.1%
    4
    0.1%
    5
    0.1%
    Taiwan
    0
    0%
    1
    0.5%
    2
    0.2%
    2
    0.1%
    5
    0.1%
    Clinical Status (7-point ordinal scale) (Count of Participants)
    Score: 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Score: 2
    4
    2%
    9
    4.6%
    844
    100%
    0
    0%
    857
    17.7%
    Score: 3
    49
    24.5%
    59
    29.9%
    0
    0%
    1069
    29.7%
    1177
    24.3%
    Score: 4
    113
    56.5%
    108
    54.8%
    0
    0%
    2214
    61.6%
    2435
    50.3%
    Score: 5
    34
    17%
    21
    10.7%
    0
    0%
    314
    8.7%
    369
    7.6%
    Score: 6
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Score: 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14
    Description Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol remdesivir administration); 7. Not hospitalized. The odds ratio represents the odds of improvement in the ordinal scale for the Remdesivir for 10 days group vs the Remdesivir for 5 days group.
    Time Frame Day 14

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment.
    Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days
    Arm/Group Description Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    Measure Participants 200 197
    Score: 1
    8.0
    4%
    10.7
    5.4%
    Score: 2
    8.5
    4.3%
    16.8
    8.5%
    Score: 3
    4.0
    2%
    5.1
    2.6%
    Score: 4
    9.5
    4.8%
    7.6
    3.9%
    Score: 5
    6.0
    3%
    6.1
    3.1%
    Score: 6
    4.0
    2%
    1.5
    0.8%
    Score: 7
    60.0
    30%
    52.3
    26.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1563
    Comments P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.
    Method Proportional odds model
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.507 to 1.115
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0368
    Comments P-value was calculated using a proportional odds model with treatment as the independent variable.
    Method Proportional odds model
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.67
    Confidence Interval (2-Sided) 95%
    0.458 to 0.976
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
    Description Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.
    Time Frame First dose date up to last dose date (maximum: 10 days) plus 30 days

    Outcome Measure Data

    Analysis Population Description
    Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study drug
    Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days
    Arm/Group Description Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    Measure Participants 200 197
    Number (95% Confidence Interval) [percentage of participants]
    71.5
    35.8%
    75.1
    38.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Part A: Remdesivir (RDV) for 5 Days, Part A: Remdesivir for 10 Days
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7678
    Comments P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -7.4 to 10.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Part A: First dose date up to the last dose date (maximum: 10 days) plus 30 days; Part B: First dose date up to the last dose date (maximum: 11 days) plus 30 days
    Adverse Event Reporting Description Part A: Safety Analysis Set included participants who were randomized into part A of the study and received at least 1 dose of study treatment;Part B: Expanded RDV-Treated Analysis Set included participants who were enrolled into part B of the study and received at least 1 dose of study treatment.
    Arm/Group Title Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group)
    Arm/Group Description Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-5. Participants received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants on mechanical ventilation received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10. Participants who were not mechanically ventilated received continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2-10.
    All Cause Mortality
    Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/200 (12.5%) 28/197 (14.2%) 213/844 (25.2%) 422/3597 (11.7%)
    Serious Adverse Events
    Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 43/200 (21.5%) 68/197 (34.5%) 362/844 (42.9%) 851/3597 (23.7%)
    Blood and lymphatic system disorders
    Anaemia 0/200 (0%) 1/197 (0.5%) 4/844 (0.5%) 9/3597 (0.3%)
    Bicytopenia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Blood loss anaemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Bone marrow failure 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Coagulopathy 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Disseminated intravascular coagulation 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 3/3597 (0.1%)
    Leukocytosis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Neutropenia 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Splenic infarction 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Thrombocytopenia 1/200 (0.5%) 0/197 (0%) 0/844 (0%) 0/3597 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/200 (0%) 1/197 (0.5%) 4/844 (0.5%) 2/3597 (0.1%)
    Angina pectoris 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Arrhythmia 1/200 (0.5%) 0/197 (0%) 3/844 (0.4%) 3/3597 (0.1%)
    Atrial fibrillation 0/200 (0%) 0/197 (0%) 10/844 (1.2%) 12/3597 (0.3%)
    Atrial flutter 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Atrioventricular block complete 0/200 (0%) 0/197 (0%) 0/844 (0%) 3/3597 (0.1%)
    Atrioventricular block second degree 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Bradycardia 1/200 (0.5%) 0/197 (0%) 2/844 (0.2%) 3/3597 (0.1%)
    Cardiac arrest 0/200 (0%) 2/197 (1%) 15/844 (1.8%) 34/3597 (0.9%)
    Cardiac failure 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 2/3597 (0.1%)
    Cardiac failure acute 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 1/3597 (0%)
    Cardiac failure congestive 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Cardio-respiratory arrest 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 11/3597 (0.3%)
    Cardiogenic shock 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 5/3597 (0.1%)
    Cardiomyopathy 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Cyanosis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Myocardial infarction 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 4/3597 (0.1%)
    Myocardial ischaemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Pericarditis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pulseless electrical activity 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 5/3597 (0.1%)
    Right ventricular dysfunction 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Right ventricular failure 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Stress cardiomyopathy 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Supraventricular tachycardia 1/200 (0.5%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Tachycardia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Ventricular arrhythmia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Ventricular fibrillation 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Ventricular tachycardia 1/200 (0.5%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Abdominal wall haematoma 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Colitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Diverticular perforation 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Duodenal ulcer 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Dysphagia 1/200 (0.5%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Gastric perforation 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Gastrointestinal haemorrhage 0/200 (0%) 1/197 (0.5%) 1/844 (0.1%) 3/3597 (0.1%)
    Haematemesis 0/200 (0%) 0/197 (0%) 0/844 (0%) 3/3597 (0.1%)
    Ileus 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Ileus paralytic 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Intestinal ischaemia 0/200 (0%) 0/197 (0%) 3/844 (0.4%) 2/3597 (0.1%)
    Intestinal pseudo-obstruction 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Intra-abdominal haematoma 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Lower gastrointestinal haemorrhage 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Pancreatitis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Pancreatitis acute 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pancreatitis necrotising 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pneumatosis intestinalis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Rectal haemorrhage 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Retroperitoneal haematoma 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Retroperitoneal haemorrhage 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 2/3597 (0.1%)
    Stomatitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Upper gastrointestinal haemorrhage 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Vomiting 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    General disorders
    Asthenia 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Brain death 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Chest pain 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Death 1/200 (0.5%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Fatigue 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hyperthermia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Hyperthermia malignant 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Multi-organ disorder 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Multiple organ dysfunction syndrome 2/200 (1%) 4/197 (2%) 27/844 (3.2%) 32/3597 (0.9%)
    Oedema 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Oedema peripheral 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pelvic mass 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Procedural failure 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Pyrexia 0/200 (0%) 1/197 (0.5%) 4/844 (0.5%) 5/3597 (0.1%)
    Hepatobiliary disorders
    Acute hepatic failure 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Biliary colic 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hepatic failure 1/200 (0.5%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Hyperbilirubinaemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hypertransaminasaemia 0/200 (0%) 1/197 (0.5%) 1/844 (0.1%) 0/3597 (0%)
    Ischaemic hepatitis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Immune system disorders
    Cytokine release syndrome 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 5/3597 (0.1%)
    Cytokine storm 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 2/3597 (0.1%)
    Drug hypersensitivity 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hypersensitivity 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Infections and infestations
    Abdominal abscess 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Abdominal sepsis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Bacteraemia 0/200 (0%) 0/197 (0%) 7/844 (0.8%) 3/3597 (0.1%)
    Bronchopulmonary aspergillosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Cellulitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Citrobacter bacteraemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Corona virus infection 8/200 (4%) 10/197 (5.1%) 5/844 (0.6%) 22/3597 (0.6%)
    Device related infection 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Diverticulitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Endocarditis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Enterococcal bacteraemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Escherichia bacteraemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Fungaemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Fungal infection 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Gangrene 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pneumonia 2/200 (1%) 0/197 (0%) 6/844 (0.7%) 24/3597 (0.7%)
    Pneumonia bacterial 0/200 (0%) 0/197 (0%) 7/844 (0.8%) 4/3597 (0.1%)
    Pneumonia haemophilus 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pneumonia pseudomonal 0/200 (0%) 0/197 (0%) 3/844 (0.4%) 0/3597 (0%)
    Pneumonia staphylococcal 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pneumonia viral 3/200 (1.5%) 2/197 (1%) 18/844 (2.1%) 22/3597 (0.6%)
    Pseudomonal bacteraemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pulmonary sepsis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Sepsis 2/200 (1%) 1/197 (0.5%) 11/844 (1.3%) 34/3597 (0.9%)
    Septic shock 2/200 (1%) 5/197 (2.5%) 27/844 (3.2%) 52/3597 (1.4%)
    Staphylococcal bacteraemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Staphylococcal sepsis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Subcutaneous abscess 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Superinfection 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Superinfection bacterial 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Thrombophlebitis septic 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Urinary tract infection 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Urinary tract infection bacterial 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Urosepsis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Viral myocarditis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Viral sepsis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Injury, poisoning and procedural complications
    Barotrauma 0/200 (0%) 0/197 (0%) 0/844 (0%) 3/3597 (0.1%)
    Endotracheal intubation complication 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Fall 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hip fracture 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Rib fracture 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Subdural haematoma 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Subdural haemorrhage 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Investigations
    Alanine aminotransferase increased 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 3/3597 (0.1%)
    Aspartate aminotransferase increased 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 4/3597 (0.1%)
    Bacterial test positive 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Blood alkaline phosphatase increased 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Blood bilirubin increased 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Blood creatinine increased 0/200 (0%) 0/197 (0%) 5/844 (0.6%) 2/3597 (0.1%)
    Blood pressure abnormal 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Coma scale abnormal 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Creatinine renal clearance abnormal 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Creatinine renal clearance decreased 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 4/3597 (0.1%)
    General physical condition abnormal 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Glomerular filtration rate decreased 0/200 (0%) 1/197 (0.5%) 1/844 (0.1%) 0/3597 (0%)
    Haemoglobin decreased 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hepatic enzyme increased 0/200 (0%) 1/197 (0.5%) 1/844 (0.1%) 0/3597 (0%)
    Liver function test increased 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 2/3597 (0.1%)
    Myocardial necrosis marker increased 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Oxygen consumption increased 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Oxygen saturation abnormal 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Oxygen saturation decreased 1/200 (0.5%) 0/197 (0%) 0/844 (0%) 5/3597 (0.1%)
    Platelet count decreased 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Transaminases increased 3/200 (1.5%) 2/197 (1%) 6/844 (0.7%) 3/3597 (0.1%)
    Troponin increased 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Urine output decreased 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Metabolism and nutrition disorders
    Acidosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Decreased appetite 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Diabetes mellitus 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Diabetic ketoacidosis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Fluid overload 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hyperglycaemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hyperkalaemia 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 2/3597 (0.1%)
    Hypernatraemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hypocalcaemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Hypoglycaemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hyponatraemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Hypovolaemia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Malnutrition 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Metabolic acidosis 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 1/3597 (0%)
    Type 2 diabetes mellitus 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Chest wall haematoma 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Compartment syndrome 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Haematoma muscle 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Muscle haemorrhage 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Musculoskeletal chest pain 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pain in extremity 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Rhabdomyolysis 0/200 (0%) 0/197 (0%) 4/844 (0.5%) 0/3597 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bone cancer 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Nervous system disorders
    Autonomic nervous system imbalance 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Brain injury 0/200 (0%) 0/197 (0%) 3/844 (0.4%) 1/3597 (0%)
    Brain oedema 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Cerebellar infarction 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Cerebral haemorrhage 0/200 (0%) 0/197 (0%) 3/844 (0.4%) 4/3597 (0.1%)
    Cerebral infarction 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 3/3597 (0.1%)
    Cerebral microhaemorrhage 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Cerebrovascular accident 0/200 (0%) 0/197 (0%) 4/844 (0.5%) 7/3597 (0.2%)
    Coma 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Dizziness 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Embolic stroke 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Encephalopathy 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 2/3597 (0.1%)
    Facial paralysis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Guillain-Barre syndrome 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Haemorrhage intracranial 0/200 (0%) 0/197 (0%) 4/844 (0.5%) 2/3597 (0.1%)
    Headache 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hypoxic-ischaemic encephalopathy 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Iiird nerve disorder 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Ischaemic stroke 0/200 (0%) 0/197 (0%) 0/844 (0%) 4/3597 (0.1%)
    Lethargy 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Nervous system disorder 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Posterior reversible encephalopathy syndrome 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Seizure 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 3/3597 (0.1%)
    Seizure like phenomena 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Syncope 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Thrombotic stroke 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Toxic encephalopathy 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Transient ischaemic attack 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Product Issues
    Device dislocation 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Psychiatric disorders
    Confusional state 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Delirium 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Mental status changes 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 10/3597 (0.3%)
    Paranoia 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Renal and urinary disorders
    Acute kidney injury 2/200 (1%) 3/197 (1.5%) 50/844 (5.9%) 69/3597 (1.9%)
    Anuria 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Azotaemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Renal failure 1/200 (0.5%) 1/197 (0.5%) 13/844 (1.5%) 17/3597 (0.5%)
    Renal impairment 0/200 (0%) 0/197 (0%) 4/844 (0.5%) 1/3597 (0%)
    Renal tubular necrosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Urinary retention 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Reproductive system and breast disorders
    Priapism 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 1/200 (0.5%) 4/197 (2%) 23/844 (2.7%) 42/3597 (1.2%)
    Acute respiratory failure 10/200 (5%) 18/197 (9.1%) 36/844 (4.3%) 121/3597 (3.4%)
    Aspiration 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Bronchiectasis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Chronic obstructive pulmonary disease 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Dyspnoea 4/200 (2%) 1/197 (0.5%) 3/844 (0.4%) 26/3597 (0.7%)
    Emphysema 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Haemoptysis 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 1/3597 (0%)
    Haemothorax 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Hypercapnia 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Hyperoxia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Hypoxia 2/200 (1%) 4/197 (2%) 14/844 (1.7%) 78/3597 (2.2%)
    Interstitial lung disease 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Lung opacity 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Pharyngeal haemorrhage 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Pickwickian syndrome 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pleural effusion 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Pneumomediastinum 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 3/3597 (0.1%)
    Pneumonia aspiration 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 3/3597 (0.1%)
    Pneumonitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pneumothorax 2/200 (1%) 4/197 (2%) 6/844 (0.7%) 25/3597 (0.7%)
    Pneumothorax spontaneous 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Pulmonary embolism 1/200 (0.5%) 4/197 (2%) 9/844 (1.1%) 32/3597 (0.9%)
    Pulmonary oedema 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Pulmonary thrombosis 1/200 (0.5%) 0/197 (0%) 0/844 (0%) 0/3597 (0%)
    Respiratory acidosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 2/3597 (0.1%)
    Respiratory arrest 1/200 (0.5%) 0/197 (0%) 2/844 (0.2%) 2/3597 (0.1%)
    Respiratory disorder 1/200 (0.5%) 1/197 (0.5%) 2/844 (0.2%) 22/3597 (0.6%)
    Respiratory distress 3/200 (1.5%) 5/197 (2.5%) 14/844 (1.7%) 71/3597 (2%)
    Respiratory failure 6/200 (3%) 10/197 (5.1%) 59/844 (7%) 254/3597 (7.1%)
    Respiratory gas exchange disorder 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Respiratory tract haemorrhage 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Respiratory tract oedema 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Stridor 0/200 (0%) 0/197 (0%) 3/844 (0.4%) 0/3597 (0%)
    Tachypnoea 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Thoracic haemorrhage 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Skin and subcutaneous tissue disorders
    Decubitus ulcer 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Drug eruption 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 0/3597 (0%)
    Subcutaneous emphysema 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 4/3597 (0.1%)
    Social circumstances
    Social stay hospitalisation 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Vascular disorders
    Arterial thrombosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Circulatory collapse 0/200 (0%) 0/197 (0%) 2/844 (0.2%) 0/3597 (0%)
    Deep vein thrombosis 0/200 (0%) 0/197 (0%) 6/844 (0.7%) 3/3597 (0.1%)
    Distributive shock 0/200 (0%) 0/197 (0%) 0/844 (0%) 3/3597 (0.1%)
    Dry gangrene 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Embolism 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Haemodynamic instability 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Hypertension 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Hypotension 1/200 (0.5%) 3/197 (1.5%) 23/844 (2.7%) 53/3597 (1.5%)
    Hypovolaemic shock 0/200 (0%) 0/197 (0%) 0/844 (0%) 3/3597 (0.1%)
    Jugular vein thrombosis 0/200 (0%) 0/197 (0%) 0/844 (0%) 2/3597 (0.1%)
    Peripheral artery thrombosis 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Peripheral ischaemia 0/200 (0%) 0/197 (0%) 1/844 (0.1%) 1/3597 (0%)
    Shock 0/200 (0%) 0/197 (0%) 7/844 (0.8%) 11/3597 (0.3%)
    Shock haemorrhagic 0/200 (0%) 1/197 (0.5%) 2/844 (0.2%) 4/3597 (0.1%)
    Thrombophlebitis 0/200 (0%) 0/197 (0%) 0/844 (0%) 1/3597 (0%)
    Thrombosis 0/200 (0%) 1/197 (0.5%) 0/844 (0%) 0/3597 (0%)
    Other (Not Including Serious) Adverse Events
    Part A: Remdesivir (RDV) for 5 Days Part A: Remdesivir for 10 Days Part B: Remdesivir for 10 Days (Mechanically Ventilated Group) Part B: Remdesivir for 10 Days (Extension Group)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 79/200 (39.5%) 92/197 (46.7%) 508/844 (60.2%) 1258/3597 (35%)
    Blood and lymphatic system disorders
    Anaemia 7/200 (3.5%) 7/197 (3.6%) 88/844 (10.4%) 104/3597 (2.9%)
    Leukocytosis 1/200 (0.5%) 1/197 (0.5%) 47/844 (5.6%) 42/3597 (1.2%)
    Gastrointestinal disorders
    Constipation 13/200 (6.5%) 13/197 (6.6%) 78/844 (9.2%) 237/3597 (6.6%)
    Diarrhoea 10/200 (5%) 9/197 (4.6%) 54/844 (6.4%) 128/3597 (3.6%)
    Nausea 20/200 (10%) 17/197 (8.6%) 28/844 (3.3%) 220/3597 (6.1%)
    General disorders
    Pyrexia 9/200 (4.5%) 3/197 (1.5%) 65/844 (7.7%) 101/3597 (2.8%)
    Infections and infestations
    Pneumonia 1/200 (0.5%) 3/197 (1.5%) 48/844 (5.7%) 48/3597 (1.3%)
    Investigations
    Alanine aminotransferase increased 10/200 (5%) 15/197 (7.6%) 53/844 (6.3%) 164/3597 (4.6%)
    Aspartate aminotransferase increased 8/200 (4%) 13/197 (6.6%) 66/844 (7.8%) 126/3597 (3.5%)
    Transaminases increased 3/200 (1.5%) 4/197 (2%) 43/844 (5.1%) 93/3597 (2.6%)
    Metabolism and nutrition disorders
    Hyperglycaemia 8/200 (4%) 7/197 (3.6%) 62/844 (7.3%) 92/3597 (2.6%)
    Hypernatraemia 1/200 (0.5%) 2/197 (1%) 92/844 (10.9%) 59/3597 (1.6%)
    Hypokalaemia 10/200 (5%) 12/197 (6.1%) 78/844 (9.2%) 190/3597 (5.3%)
    Psychiatric disorders
    Agitation 2/200 (1%) 4/197 (2%) 74/844 (8.8%) 47/3597 (1.3%)
    Delirium 2/200 (1%) 2/197 (1%) 60/844 (7.1%) 40/3597 (1.1%)
    Insomnia 10/200 (5%) 11/197 (5.6%) 17/844 (2%) 116/3597 (3.2%)
    Renal and urinary disorders
    Acute kidney injury 2/200 (1%) 13/197 (6.6%) 113/844 (13.4%) 117/3597 (3.3%)
    Vascular disorders
    Deep vein thrombosis 4/200 (2%) 5/197 (2.5%) 50/844 (5.9%) 55/3597 (1.5%)
    Hypertension 5/200 (2.5%) 6/197 (3%) 92/844 (10.9%) 67/3597 (1.9%)
    Hypotension 8/200 (4%) 9/197 (4.6%) 99/844 (11.7%) 166/3597 (4.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04292899
    Other Study ID Numbers:
    • GS-US-540-5773
    • 2020-000841-15
    • ISRCTN15874265
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Dec 31, 2020
    Last Verified:
    Dec 1, 2020