Covid19Phase 2/3COMET-ICENCT04545060
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
A Phase 2/3 study testing VIR-7831 (sotrovimab) in people with Covid19, run by Vir Biotechnology, Inc. at 91 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- VIR-7831 (sotrovimab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,057 participants
- Where
- 91 sitesin 7 countries
- Study dates
- 27 Aug 2020to 2 Sep 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
91 sites in 7 countries.
91 sites in 7 countries
United States63 sites
Investigative Site
Anniston, Alabama, 36207
Investigative Site
Asheboro, North Carolina, 27203
Investigative Site
Atlanta, Georgia, 30315
Investigative Site
Atlanta, Georgia, 30318
Investigative Site
Austin, Texas, 78705
Investigative Site
Baltimore, Maryland, 21230
Investigative Site
Baytown, Texas, 77521
Investigative Site
Beaumont, Texas, 77702
Investigative Site
Caro, Michigan, 48723
Investigative Site
Charlotte, North Carolina, 28208
Investigative Site
Chattanooga, Tennessee, 37421
Investigative Site
Columbus, Ohio, 43215
Investigative Site
Cullman, Alabama, 35055
Investigative Site
Dallas, Texas, 75231
Investigative Site
Decatur, Georgia, 30030
Investigative Site
Denton, Texas, 76210
Investigative Site
Doral, Florida, 33166
Investigative Site
El Paso, Texas, 79935
Investigative Site
Forney, Texas, 75126
Investigative Site
Gainesville, Florida, 32607
Investigative Site
Hazelwood, Missouri, 63042
Investigative Site
Hialeah, Florida, 33016
Investigative Site
Houston, Texas, 77017
Investigative Site
Houston, Texas, 77024
Investigative Site
Houston, Texas, 77058
Investigative Site
Houston, Texas, 77090
Investigative Site
Humble, Texas, 77338
Investigative Site
Idaho Falls, Idaho, 83404
Investigative Site
Kirkland, Washington, 98034
Investigative Site
Lake Charles, Louisiana, 70601
Investigative Site
Laredo, Texas, 78041
Investigative Site
Las Vegas, Nevada, 89109
Investigative Site
Las Vegas, Nevada, 89130
Investigative Site
Los Angeles, California, 90017
Investigative Site
Los Angeles, California, 90036
Investigative Site
Marrero, Louisiana, 70072
Investigative Site
McAllen, Texas, 78504
Investigative Site
Mesa, Arizona, 85210
Investigative Site
Mesquite, Texas, 75149
Investigative Site
Miami, Florida, 33122
Investigative Site
Miami, Florida, 33125
Investigative Site
Miami, Florida, 33155
Investigative Site
Miami, Florida, 33173
Investigative Site
Miami, Florida, 33186
Investigative Site
Miramar, Florida, 33027
Investigative Site
Mishawaka, Indiana, 46544
Investigative Site
North Miami, Florida, 33169
Investigative Site
Northridge, California, 91325
Investigative Site
Oxnard, California, 93030
Investigative Site
Palmetto Bay, Florida, 33157
Investigative Site
Pembroke Pines, Florida, 33024
Investigative Site
Pompano Beach, Florida, 33064
Investigative Site
Rolling Hills Estates, California, 90274
Investigative Site
Sacramento, California, 95817
Investigative Site
Santa Fe, New Mexico, 87505
Investigative Site
Seattle, Washington, 98109
Investigative Site
Smithfield, Pennsylvania, 15478
Investigative Site
Stockbridge, Georgia, 30281
Investigative Site
Sugar Land, Texas, 77478
Investigative Site
Tampa, Florida, 33614
Investigative Site
Tampa, Florida, 33615
Investigative Site
The Bronx, New York, 10456
Investigative Site
Tucson, Arizona, 85712
Brazil10 sites
Investigative Site
Belo Horizonte, Minas Gerais, 30110-934
Investigative Site
Campinas, São Paulo, 13060-904
Investigative Site
Chapecó, Santa Catarina, 89801-355
Investigative Site
Maringá, Paraná, 87083-240
Investigative Site
Natal, Rio Grande do Norte, 590250-50
Investigative Site
Passo Fundo, Rio Grande do Sul, 99010-120
Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-903
Investigative Site
Santo André, São Paulo, 09030-010
Investigative Site
Vila Assuncao, São Paulo, 05615-190
Peru6 sites
Investigative Site
Bella Vista, 07006
Investigative Site
Bellavista, Provincia Constitucional del Callao, 7016
Investigative Site
El Agustino, Lima region, 15007
Investigative Site
Huaral, Lima region, 15131
Investigative Site
Lima, 15082
Investigative Site
San Isidro, Lima region, 15036
Spain6 sites
Investigative Site
Albacete, 02006
Investigative Site
Centelles, Barcelona, 08540
Investigative Site
Girona, 17005
Investigative Site
Granada, 18014
Investigative Site
Terrassa, Barcelona, 08221
Investigative Site
Vigo, 36312
Canada3 sites
Investigative Site
Québec, Quebec, G2J0C4
Investigative Site
Sarnia, Ontario, N7T 4X3
Investigative Site
Toronto, Ontario, M9V 4B4
About this study
Official title: A Phase II/III 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
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.
- Conditions
- Covid19
- Being tested
- VIR-7831 (sotrovimab), Placebo
- Keywords
- SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-7831 (sotrovimab)Biological
VIR-7831 (sotrovimab) given by intravenous infusion (single dose)
PlaceboDrug
Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)
| Study group | Role | What they receive |
|---|---|---|
| VIR-7831 (Sotrovimab) | Experimental | Participants received 500 mg sotrovimab administered intravenously (IV) Receives: Biological: VIR-7831 (sotrovimab) |
| Placebo | Placebo comparator | Participants received placebo administered intravenously (IV) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Progression of COVID-19 Through Day 29
COVID-19 progression defined as hospitalization >24 hours or death
Measured: Through Day 29
Secondary outcomes (28)
Number of Participants With Adverse Events (AEs)
Measured: Up to 24 weeks
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to 24 weeks
Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions
Measured: Up to 24 weeks
Number of Participants With Cardiac Events of Special Interest
Measured: Up to 24 weeks
Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab
Measured: Up to 24 weeks
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab
Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.
Measured: Up to 24 Weeks
Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Clearance (CL) of VIR-7831 After IV Administration
Measured: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Number of Participants Who Had Progression of COVID-19
COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death
Measured: Through Day 29
Mean Change in FLU PRO Plus Total Score (AUC)
Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score.
The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach.
Measured: Through Day 7
Time to Symptom Alleviation Using FLU-PRO Plus
Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for >=48 hours. Participants could only achieve sustained symptom alleviation following >=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation.
The FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste.
Measured: Through Day 21
Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8
Measured: Baseline and Day 8
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8
Measured: Through Day 8
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15
Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.
Measured: Through Day 15
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22
Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.
Measured: Through Day 22
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29
Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.
Measured: Through Day 29
29-day All-cause Mortality
Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal
Measured: Through Day 29
60-day All-cause Mortality
Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal
Measured: Through Day 60
90-day All-cause Mortality
Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal
Measured: Through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start27 Aug 2020
- Primary completion8 Apr 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545060
- Sponsor's protocol ID
- VIR-7831-5001
- Other IDs
- GSK Study 214367
- Acronym
- COMET-ICE
- Status last verified
- Oct 2022
- First submitted
- 4 Sep 2020
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Maher MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A. Antibody therapy reverses biological signatures of COVID-19 progression. Cell Rep Med. 2022 Aug 16;3(8):100721. doi: 10.1016/j.xcrm.2022.100721.
PubMed 35977462Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1236-1246. doi: 10.1001/jama.2022.2832.
PubMed 35285853Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
PubMed 34706189Subramanian S, Schnell G, Iulio JD, Gupta AK, Shapiro AE, Sarkis EH, Lopuski A, Peppercorn A, Aldinger M, Hebner CM, Cathcart AL. Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study. Future Virol. 2023 Nov:10.2217/fvl-2023-0146. doi: 10.2217/fvl-2023-0146. Epub 2023 Dec 7.
PubMed 38074312Satram S, Ghafoori P, Reyes CM, Keeley TJH, Birch HJ, Brintziki D, Aldinger M, Alexander E, Lopuski A, Sarkis EH, Gupta A, Shapiro AE, Powers JH 3rd. Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19. J Patient Rep Outcomes. 2023 Sep 13;7(1):92. doi: 10.1186/s41687-023-00621-8.
PubMed 37702920Keeley TJH, Satram S, Ghafoori P, Reyes C, Birch HJ, Raymond K, Gelhorn HL, Kosinski M, Saucier CD, Mitchell Foster A, Lopuski A, Powers JH 3rd. Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus(c)) instrument in patients with COVID-19. Qual Life Res. 2023 Jun;32(6):1645-1657. doi: 10.1007/s11136-022-03336-3. Epub 2023 Jan 27.
PubMed 36703019Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PubMed 35713300Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III 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
- ClinicalTrials.gov ID
- NCT04545060
- Acronym / sponsor ID
- COMET-ICE / VIR-7831-5001
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIR-7831 (Sotrovimab) | Experimental | Biological: VIR-7831 (sotrovimab)Participants received 500 mg sotrovimab administered intravenously (IV) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered intravenously (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIR-7831 (sotrovimab)VIR-7831 (sotrovimab) given by intravenous infusion (single dose) | Biological | VIR-7831 (Sotrovimab) |
| PlaceboSterile normal saline (0.9% NaCl) given by intravenous infusion (single dose) | Drug | Placebo |
Primary outcome
Number of Participants Who Had Progression of COVID-19 Through Day 29
Time frame: Through Day 29
COVID-19 progression defined as hospitalization >24 hours or death
28 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to 24 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 24 weeks
Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions
Time frame: Up to 24 weeks
Number of Participants With Cardiac Events of Special Interest
Time frame: Up to 24 weeks
Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab
Time frame: Up to 24 weeks
Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab
Time frame: Up to 24 Weeks
Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Clearance (CL) of VIR-7831 After IV Administration
Time frame: Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169
Number of Participants Who Had Progression of COVID-19
Time frame: Through Day 29
Mean Change in FLU PRO Plus Total Score (AUC)
Time frame: Through Day 7
Time to Symptom Alleviation Using FLU-PRO Plus
Time frame: Through Day 21
Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8
Time frame: Baseline and Day 8
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8
Time frame: Through Day 8
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15
Time frame: Through Day 15
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22
Time frame: Through Day 22
Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29
Time frame: Through Day 29
29-day All-cause Mortality
Time frame: Through Day 29
60-day All-cause Mortality
Time frame: Through Day 60
90-day All-cause Mortality
Time frame: Through Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35977462Maher MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A. Antibody therapy reverses biological signatures of COVID-19 progression. Cell Rep Med. 2022 Aug 16;3(8):100721. doi: 10.1016/j.xcrm.2022.100721.
- Results publication: PubMed 35285853Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1236-1246. doi: 10.1001/jama.2022.2832.
- Results publication: PubMed 34706189Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.
- Derived from this study: PubMed 38074312Subramanian S, Schnell G, Iulio JD, Gupta AK, Shapiro AE, Sarkis EH, Lopuski A, Peppercorn A, Aldinger M, Hebner CM, Cathcart AL. Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study. Future Virol. 2023 Nov:10.2217/fvl-2023-0146. doi: 10.2217/fvl-2023-0146. Epub 2023 Dec 7.
- Derived from this study: PubMed 37702920Satram S, Ghafoori P, Reyes CM, Keeley TJH, Birch HJ, Brintziki D, Aldinger M, Alexander E, Lopuski A, Sarkis EH, Gupta A, Shapiro AE, Powers JH 3rd. Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19. J Patient Rep Outcomes. 2023 Sep 13;7(1):92. doi: 10.1186/s41687-023-00621-8.
- Derived from this study: PubMed 36703019Keeley TJH, Satram S, Ghafoori P, Reyes C, Birch HJ, Raymond K, Gelhorn HL, Kosinski M, Saucier CD, Mitchell Foster A, Lopuski A, Powers JH 3rd. Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus(c)) instrument in patients with COVID-19. Qual Life Res. 2023 Jun;32(6):1645-1657. doi: 10.1007/s11136-022-03336-3. Epub 2023 Jan 27.
- Derived from this study: PubMed 35713300Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VIR-7831 (sotrovimab) in people with Covid19, run by Vir Biotechnology, Inc. at 91 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Brazil, Peru, Spain, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Progression of COVID-19 Through Day 29 (time frame: Through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545060, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.