COMET-PEAK: Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Study Details
Study Description
Brief Summary
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Sotrovimab (Gen1) Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material | Biological: Sotrovimab (Gen1) Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material Biological: Sotrovimab (Gen2) Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection |
Active Comparator: Sotrovimab (Gen2) Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection | Biological: Sotrovimab (Gen2) Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection |
Outcome Measures
Primary Outcome Measures
- Occurrence of adverse events (AEs) in Part A participants [Through Day 29]
- Occurrence of serious adverse events (SAEs) in Part A participants [Through Day 29]
- Occurrence of adverse events of special interest (AESIs) in Part A participants [Through Day 29]
- Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Part A participants readings [Through Day 29]
- Occurrence of disease progression events (not classified as AEs) in Part A participants [Through Day 29]
- Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part B study participants [Day 1 through Day 8]
Measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in nasopharyngeal swab samples
- Mean area under the curve (AUC) of SARS-CoV-2 viral load in Part C study participants [Day 1 through Day 8]
Measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in nasopharyngeal swab samples
Secondary Outcome Measures
- Cmax [Through 24 weeks]
- Clast [Through 24 weeks]
- Tmax [Through 24 weeks]
- Tlast [Through 24 weeks]
- AUCD0-28 [Through 24 weeks]
- AUCinf [Through 24 weeks]
- AUClast [Through 24 weeks]
- %AUCexp [Through 24 weeks]
- t1/2 [Through 24 weeks]
- Vz [Through 24 weeks]
- Vss [Through 24 weeks]
- CL [Through 24 weeks]
- Occurrence of SAEs in Part A participants [Through 24 weeks]
- Occurrence of AESIs in Part A participants [Through 24 weeks]
- Occurrence of clinically significant abnormalities on 12-lead ECG readings in Part A participants [Through 12 weeks]
- Occurrence of disease progression events (not classified as AEs) in Part A participants [Through 24 weeks]
- Occurrence of non-serious AEs in Part A participants [Through 12 weeks]
- Occurrence of adverse events (AEs) in Parts B and C participants [Through Day 29]
- Occurrence of serious adverse events (SAEs) in Parts B and C participants [Through Day 29]
- Occurrence of adverse events of special interest (AESIs) in Parts B and C participants [Through Day 29]
- Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) in Parts B and C participants [Through Day 29]
- Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [Through Day 29]
- Occurrence of non-serious AEs in Parts B and C participants [Through 12 weeks]
- Occurrence of SAEs in Parts B and C participants [Through 24 weeks]
- Occurrence of AESIs in Parts B and C participants [Through 24 weeks]
- Occurrence of clinically significant abnormalities on 12-lead ECG readings in Parts B and C participants [Through 12 weeks]
- Occurrence of disease progression events (not classified as AEs) in Parts B and C participants [Through 24 weeks]
- Change from baseline in viral load at all visits in Part A participants [Through Day 29]
Measured by qRT-PCR from saliva and nasal mid-turbinate swabs samples
- Change from baseline in viral load at all visits in Parts B and C participants [Through Day 29]
Measured by qRT-PCR from nasopharyngeal (NP) swab samples
- Proportion of participants with undetectable viral load at all visits in Parts B and C participants [Through Day 29]
Measured by qRT-PCR from nasopharyngeal (NP) swab samples
- Mean area under the curve of SARS-CoV-2 viral load in Parts B and C participants [Day 1 through Day 5 and Day 1 through Day 11]
Measured by qRT-PCR
- Proportion of individuals with a persistently high viral load in Parts B and C participants [Day 8]
Assessed via qRT-PCR in NP swab samples
- Presence of SARS-CoV-2 viral resistance mutants [Baseline]
- Incidence (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [Through 24 weeks]
- Titers (if applicable) of serum anti-drug antibodies (ADA) to VIR-7831 [Through 24 weeks]
- Incidence (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies [Baseline]
- Titers (if applicable) of anti-nucleocapsid (anti-N), anti-spike (anti-S) and anti-receptor binding domain (anti-RBD) SARS-CoV-2 antibodies [Baseline]
- Incidence (if applicable) of anti-N SARS-CoV-2 antibodies [Day 29]
- Titers (if applicable) of anti-N SARS-CoV-2 antibodies [Day 29]
- Emergence of SARS-CoV-2 viral resistance mutants [Through 24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
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For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
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Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from onset of symptoms
Exclusion Criteria:
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Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
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Symptoms consistent with severe COVID-19
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Participants who, in the judgement of the investigator are likely to die in the next 7 days.
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Severely immunocompromised participants
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For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
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For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
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For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigative Site | Anniston | Alabama | United States | 36207 |
2 | Investigative Site | Bakersfield | California | United States | 93301 |
3 | Investigative Site | Northridge | California | United States | 91325 |
4 | Investigative Site | Fort Pierce | Florida | United States | 34982 |
5 | Investigative Site | Gainesville | Florida | United States | 32607 |
6 | Investigative Site | Hialeah | Florida | United States | 33016 |
7 | Investigative Site | Miami | Florida | United States | 33125 |
8 | Investigative Site | Miami | Florida | United States | 33135 |
9 | Investigative Site | Miami | Florida | United States | 33155 |
10 | Investigative Site | Miami | Florida | United States | 33176 |
11 | Investigative Site | Orlando | Florida | United States | 32803 |
12 | Investigative Site | Pembroke Pines | Florida | United States | 33024 |
13 | Investigative Site | Tampa | Florida | United States | 33614 |
14 | Investigative Site | Columbus | Georgia | United States | 31904 |
15 | Investigative Site | Winfield | Illinois | United States | 60190 |
16 | Investigative Site | Rockville | Maryland | United States | 20850 |
17 | Investigative Site | Bronx | New York | United States | 10456 |
18 | Investigative Site | Houston | Texas | United States | 77090 |
19 | Investigative Site | Sarnia | Ontario | Canada | N7T 4X3 |
20 | Investigative Site | Toronto | Ontario | Canada | M9V 4B4 |
21 | Investigative Site | Milano | Italy | 20132 | |
22 | Investigative Site | Daejeon | Korea, Republic of | 35015 | |
23 | Investigative Site | Alicante | Spain | 03010 | |
24 | Investigative Site | Barcelona | Spain | 08006 | |
25 | Investigative Site | Centelles | Spain | 08540 | |
26 | Investigative Site | Granada | Spain | 18014 | |
27 | Investigative Site | La Roca Del Vallès | Spain | 08430 | |
28 | Investigative Site | Madrid | Spain | 28031 | |
29 | Investigative Site | Madrid | Spain | 28040 | |
30 | Investigative Site | Pozuelo De Alarcón | Spain | 28223 | |
31 | Investigative Site | Vigo | Spain | 36312 |
Sponsors and Collaborators
- Vir Biotechnology, Inc.
- GlaxoSmithKline
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIR-7831-5006
- GSK Study 216912