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COMET-ICE: VIR-7831 for the Early Treatment of COVID-19 in Outpatients

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04545060
Collaborator
GlaxoSmithKline (Industry)
1,057
Enrollment
91
Locations
2
Arms
12.2
Actual Duration (Months)
11.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Condition or Disease Intervention/Treatment Phase
  • Biological: VIR-7831
  • Drug: Placebo
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1057 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients
Actual Study Start Date :
Aug 27, 2020
Actual Primary Completion Date :
Apr 8, 2021
Actual Study Completion Date :
Sep 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: VIR-7831

Biological: VIR-7831
VIR-7831 given by intravenous infusion
Placebo Comparator: Placebo

Drug: Placebo
Sterile normal saline (0.9% NaCl) given by intravenous infusion

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants who have progression of COVID-19 through Day 29 [Up to Day 29]

Secondary Outcome Measures

  1. Occurence of of adverse events (AEs) [Up to 24 weeks]

  2. Occurrence of serious adverse events (SAEs) [Up to 24 weeks]

  3. Occurrence of adverse events of special interest (AESI) [Up to 24 weeks]

  4. Incidence and titers (if applicable) of serum ADA to VIR-7831 [Up to 24 weeks]

  5. Cmax [Up to 24 weeks]

  6. Clast [Up to 24 weeks]

  7. Tmax [Up to 24 weeks]

  8. Tlast [Up to 24 weeks]

  9. AUCinf [Up to 24 weeks]

  10. AUClast [Up to 24 weeks]

  11. %AUCextrap [Up to 24 weeks]

  12. t1/2 [Up to 24 weeks]

  13. Vz [Up to 24 weeks]

  14. Vss [Up to 24 weeks]

  15. CL [Up to 24 weeks]

  16. Proportion of participants who have progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management or illness, or hospitalization for acute management of illness or death [Up to Day 29]

  17. Mean change in FLU PRO Plus total score comparing Vir 7831 vs Placebo (AUC through Day 7) and time to symptom alleviation using the FLU-Pro Plus [Up to Day 7]

  18. Change from baseline in viral load in nasal secretions by qRT-PCR at Day 8 [Up to Day 8]

  19. Proportion of participants who progress to develop severe and/or critical respiratory COVID-19 as manifest by requirement for and method of supplemental oxygen at Day 8, Day 15, Day 22 or Day 29 [Up to Day 29]

  20. 29-day, 60-day, and 90-day all-cause mortality [Up to 90 days]

Eligibility Criteria

Criteria

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

  • Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old

  • Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

Exclusion Criteria:

  • Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours

  • Symptoms consistent with severe COVID-19

  • Participants who, in the judgement of the investigator are likely to die in the next 7 days

  • Severely immunocompromised participants

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site Anniston Alabama United States 36207
2 Investigative Site Cullman Alabama United States 35055
3 Investigative Site Mesa Arizona United States 85210
4 Investigative Site Tucson Arizona United States 85712
5 Investigative Site Los Angeles California United States 90017
6 Investigative Site Los Angeles California United States 90036
7 Investigative Site Northridge California United States 91325
8 Investigative Site Oxnard California United States 93030
9 Investigative Site Rolling Hills Estates California United States 90274
10 Investigative Site Sacramento California United States 95817
11 Investigative Site Doral Florida United States 33166
12 Investigative Site Gainesville Florida United States 32607
13 Investigative Site Hialeah Florida United States 33016
14 Investigative Site Miami Florida United States 33122
15 Investigative Site Miami Florida United States 33125
16 Investigative Site Miami Florida United States 33155
17 Investigative Site Miami Florida United States 33173
18 Investigative Site Miami Florida United States 33186
19 Investigative Site Miramar Florida United States 33027
20 Investigative Site North Miami Florida United States 33169
21 Investigative Site Palmetto Bay Florida United States 33157
22 Investigative Site Pembroke Pines Florida United States 33024
23 Investigative Site Pompano Beach Florida United States 33064
24 Investigative Site Tampa Florida United States 33614
25 Investigative Site Tampa Florida United States 33615
26 Investigative Site Atlanta Georgia United States 30315
27 Investigative Site Atlanta Georgia United States 30318
28 Investigative Site Decatur Georgia United States 30030
29 Investigative Site Stockbridge Georgia United States 30281
30 Investigative Site Idaho Falls Idaho United States 83404
31 Investigative Site Mishawaka Indiana United States 46544
32 Investigative Site Lake Charles Louisiana United States 70601
33 Investigative Site Marrero Louisiana United States 70072
34 Investigative Site Baltimore Maryland United States 21230
35 Investigative Site Caro Michigan United States 48768
36 Investigative Site Hazelwood Missouri United States 63042
37 Investigative Site Las Vegas Nevada United States 89109
38 Investigative Site Las Vegas Nevada United States 89130
39 Investigative Site Santa Fe New Mexico United States 87505
40 Investigative Site Bronx New York United States 10456
41 Investigative Site Asheboro North Carolina United States 27203
42 Investigative Site Charlotte North Carolina United States 28208
43 Investigative Site Columbus Ohio United States 43215
44 Investigative Site Smithfield Pennsylvania United States 15478
45 Investigative Site Chattanooga Tennessee United States 37421
46 Investigative Site Austin Texas United States 78705
47 Investigative Site Baytown Texas United States 77521
48 Investigative Site Beaumont Texas United States 77702
49 Investigative Site Denton Texas United States 76210
50 Investigative Site El Paso Texas United States 79935
51 Investigative Site Forney Texas United States 75126
52 Investigative Site Houston Texas United States 77017
53 Investigative Site Houston Texas United States 77024
54 Investigative Site Houston Texas United States 77073
55 Investigative Site Houston Texas United States 77090
56 Investigative Site Humble Texas United States 77338
57 Investigative Site Laredo Texas United States 78041
58 Investigative Site McAllen Texas United States 78504
59 Investigative Site Mesquite Texas United States 75149
60 Investigative Site Sugar Land Texas United States 77478
61 Investigative Site Kirkland Washington United States 98034
62 Investigative Site Seattle Washington United States 98109
63 Investigative Site Vienna Austria 1090
64 Investigative Site Vienna Austria 1100
65 Investigative Site Belo Horizonte Minas Gerais Brazil 30.110-934
66 Investigative Site Maringá Parana Brazil 87083-240
67 Investigative Site Natal Rio Grande Do Norte Brazil 59025050
68 Investigative Site Passo Fundo Rio Grande Do Sul Brazil 99010-120
69 Investigative Site Porto Alegre Rio Grande Do Sul Brazil 90020-090
70 Investigative Site Porto Alegre Rio Grande Do Sul Brazil 90035-007
71 Investigative Site Chapecó Santa Catarina Brazil 89801-355
72 Investigative Site Santo André Sao Paulo Brazil 09030-010
73 Investigative Site Vila Assuncao Sao Paulo Brazil 05615-190
74 Investigative Site Campinas São Paulo Brazil 13060-904
75 Investigative Site Sarnia Ontario Canada N7T 4X3
76 Investigative Site Toronto Ontario Canada M9V 4B4
77 Investigative Site Québec Quebec Canada G2J0C4
78 Investigative Site Bellavista Callao Peru 7016
79 Investigative Site El Agustino Lima Peru 15007
80 Investigative Site Huaral Lima Peru 15131
81 Investigative Site San Isidro Lima Peru 15036
82 Investigative Site Bella Vista Peru 07006
83 Investigative Site Lima Peru 15082
84 Investigative Site Terrassa Barcelona Spain 8221
85 Investigative Site Albacete Spain 02006
86 Investigative Site Centelles Spain 08540
87 Investigative Site Girona Spain 17005
88 Investigative Site Granada Spain 18014
89 Investigative Site Granada Spain 18300
90 Investigative Site Vigo Spain 36312
91 Investigative Site Belfast United Kingdom

Sponsors and Collaborators

  • Vir Biotechnology, Inc.
  • GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT04545060
Other Study ID Numbers:
  • VIR-7831-5001
  • GSK Study 214367
First Posted:
Sep 10, 2020
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vir Biotechnology, Inc.
SARS-CoV-2
coronavirus
coronavirus disease 2019
COVID-19
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Sep 27, 2021