Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04913675
Collaborator
GlaxoSmithKline (Industry)
983
Enrollment
50
Locations
3
Arms
13.7
Anticipated Duration (Months)
19.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: VIR-7831
  • Biological: VIR-7831
  • Biological: VIR-7831
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
983 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients.
Actual Study Start Date :
Jun 10, 2021
Actual Primary Completion Date :
Sep 18, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: VIR-7831 (Sotrovimab) 500mg IV

VIR-7831 given by intravenous infusion

Biological: VIR-7831
500mg IV

Experimental: VIR-7831 (Sotrovimab) 500mg IM

VIR-7831 given by intramuscular injection

Biological: VIR-7831
500mg IM

Experimental: VIR-7831 (Sotrovimab) 250mg IM

VIR-7831 given by intramuscular injection

Biological: VIR-7831
250mg IM

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants who have progression of COVID-19 [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 (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [Up to 24 weeks]

  5. Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab [Up to 24 weeks]

  6. Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR [Up to Day 8]

  7. Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR [Up to Day 8]

  8. Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) [Up to Day 8]

  9. Proportion of participants who progress to develop severe and/or critical respiratory corona virus disease- 2019 (COVID-19) as manifest by requirement for and method of supplemental oxygen [Up to Day 29]

  10. Serum concentration at end of intravenous infusion (IV) [Up to 24 Weeks]

  11. Intravenous serum concentration (IV) [at Day 29]

  12. Intramuscular serum concentration (IM) [at Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participant must be aged 12 years or older at time of consent 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 7 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

  • Known hypersensitivity to any constituent present in the investigational product

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Investigative SiteAnnistonAlabamaUnited States36207
2Investigative SiteMesaArizonaUnited States85210
3Investigative SiteTucsonArizonaUnited States85712
4Investigative SiteLos AngelesCaliforniaUnited States90017
5Investigative SiteRolling Hills EstatesCaliforniaUnited States90274
6Investigative SiteBradentonFloridaUnited States34208
7Investigative SiteDoralFloridaUnited States33126
8Investigative SiteDoralFloridaUnited States33166
9Investigative SiteGainesvilleFloridaUnited States32607
10Investigative SiteHialeahFloridaUnited States33012
11Investigative SiteHialeahFloridaUnited States33013
12Investigative SiteHialeahFloridaUnited States33016
13Investigative SiteMiamiFloridaUnited States33032
14Investigative SiteMiamiFloridaUnited States33125
15Investigative SiteMiamiFloridaUnited States33126
16Investigative SiteMiamiFloridaUnited States33135
17Investigative SiteMiamiFloridaUnited States33144
18Investigative SiteMiamiFloridaUnited States33155
19Investigative SiteMiamiFloridaUnited States33175
20Investigative SiteMiamiFloridaUnited States33176
21Investigative SiteMiamiFloridaUnited States33180
22Investigative SiteNorth Miami BeachFloridaUnited States33169
23Investigative SiteOrmond BeachFloridaUnited States32174
24Investigative SitePalmetto BayFloridaUnited States33157
25Investigative SitesPembroke PinesFloridaUnited States33024
26Investigative SitePompano BeachFloridaUnited States33064
27Investigative SiteTampaFloridaUnited States33614
28Investigative SiteTampaFloridaUnited States33615
29Investigative SiteAtlantaGeorgiaUnited States30318
30Investigative SiteIdaho FallsIdahoUnited States83404
31Investigative SiteMishawakaIndianaUnited States46544
32Investigative SiteSterling HeightsMichiganUnited States48126
33Investigative SiteLas VegasNevadaUnited States89113
34Investigative SiteBronxNew YorkUnited States10456
35Investigative SiteHigh PointNorth CarolinaUnited States27262
36Investigative SiteMount AiryNorth CarolinaUnited States27030
37Investigative SiteColumbusOhioUnited States43215
38Investigative SiteSmithfieldPennsylvaniaUnited States15478
39Investigative SiteBaytownTexasUnited States77521
40Investigative SiteForneyTexasUnited States75126
41Investigative SiteHoustonTexasUnited States77017
42Investigative SiteHoustonTexasUnited States77024
43Investigative SiteHoustonTexasUnited States77090
44Investigative SiteLaredoTexasUnited States78041
45Investigative SiteMesquiteTexasUnited States75149
46Investigative SitePharrTexasUnited States78577
47Investigative SiteKirklandWashingtonUnited States98034
48Investigative SiteSeattleWashingtonUnited States98109
49Investigative SiteLimogesHaute-ViennaFrance87042
50Investigative SiteKyivUkraine02000

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:
NCT04913675
Other Study ID Numbers:
  • VIR-7831-5008
First Posted:
Jun 4, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 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.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021