Phase 2
N=30
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04779879 ↗Enrolled (actual)
30
Serious AEs
2.3%
Results posted
Nov 2022
Primary outcome: Primary: Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 — 0; 3; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sotrovimab (Gen1) (Biological); Sotrovimab (Gen2) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vir Biotechnology, Inc.
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29 |
0; 3; 0; 0 | — |
| PRIMARY Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29 |
0; 0; 6; 17 | — |
| PRIMARY Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 |
0; 0 | — |
| PRIMARY Part B: Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 (AUCD1-8) |
24.40; 25.28 | — |
| PRIMARY Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8) |
26.20; 26.72 | — |
| SECONDARY Part A: Number of Participants With Non-Serious AEs Through Week 12 |
0; 0 | — |
| SECONDARY Part A: Number of Participants With SAEs Through Week 24 |
0; 0 | — |
| SECONDARY Part A: Number of Participants With AESI Through Week 24 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points |
0; 0; 4; 13; 0; 0 | — |
| SECONDARY Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24 |
0; 0 | — |
| SECONDARY Part B: Number of Participants With All AEs and SAEs Through Day 29 |
8; 17; 1; 2 | — |
| SECONDARY Part B: Number of Participants With AESI Through Day 29 |
0; 1; 0; 10; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 |
1; 1; 43; 39 | — |
| SECONDARY Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 |
0; 3 | — |
| SECONDARY Part C: Number of Participants With All AEs and SAEs Through Day 29 |
10; 13; 1; 3 | — |
| SECONDARY Part C: Number of Participants With AESI Through Day 29 |
0; 0; 0; 4; 0; 0 | — |
| SECONDARY Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29 |
0; 0; 38; 37 | — |
| SECONDARY Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29 |
0; 0 | — |
| SECONDARY Part B: Number of Participants With Non-Serious AEs Through Week 12 |
8; 20 | — |
| SECONDARY Part B: Number of Participants With SAEs Through Week 36 |
1; 2 | — |
| SECONDARY Part B: Number of Participants With AESI Through Week 36 |
0; 1; 0; 10; 0; 0 | — |
| SECONDARY Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points |
1; 0; 33; 31; 0; 1 | — |
| SECONDARY Part B: Number of Participants With Disease Progression Events Through Week 36 |
2; 3 | — |
| SECONDARY Part C: Number of Participants With Non-Serious AEs Through Week 12 |
16; 16 | — |
| SECONDARY Part C: Number of Participants With SAEs Through Week 36 |
2; 3 | — |
| SECONDARY Part C: Number of Participants With AESI Through Week 36 |
0; 0; 0; 4; 0; 0 | — |
| SECONDARY Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points |
0; 0; 29; 28; 0; 0 | — |
| SECONDARY Part C: Number of Participants With Disease Progression Events Through Week 36 |
1; 4 | — |
| SECONDARY Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load |
-0.270; -1.114; -0.780; -2.620; -0.507; -2.605 | — |
| SECONDARY Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples |
-1.146; -0.611; -1.438; -1.306; -2.578; -2.352 | — |
| SECONDARY Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples |
-0.429; -0.519; -0.905; -1.123; -2.076; -1.967 | — |
| SECONDARY Part B: Percentage of Participants With Undetectable Viral Load |
10; 4; 11; 9; 23; 27 | — |
| SECONDARY Part C: Percentage of Participants With Undetectable Viral Load |
10; 5; 10; 14; 28; 16 | — |
| SECONDARY Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) |
16.14; 16.97 | — |
| SECONDARY Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) |
31.69; 32.39 | — |
| SECONDARY Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5) |
17.42; 17.56 | — |
| SECONDARY Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11) |
33.02; 33.63 | — |
| SECONDARY Part B: Percentage of Participants With a Persistently High Viral Load at Day 8 |
17; 11; 83; 89 | — |
| SECONDARY Part C: Percentage of Participants With a Persistently High Viral Load at Day 8 |
15; 13; 85; 87 | — |
| SECONDARY Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration |
147.1; 204.7 | — |
| SECONDARY Part B: Cmax of VIR-7831 After IV Administration |
156.5 | — |
| SECONDARY Part B: Cmax of VIR-7831 After IM Administration |
28.8 | — |
| SECONDARY Part C: Cmax of VIR-7831 After IV Administration |
137.4 | — |
| SECONDARY Part C: Cmax of VIR-7831 After IM Administration |
11.1 | — |
| SECONDARY Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration |
6.9; 8.1 | — |
| SECONDARY Part B: Clast of VIR-7831 After IV Administration |
7.0 | — |
| SECONDARY Part B: Clast of VIR-7831 After IM Administration |
7.9 | — |
| SECONDARY Part C: Clast of VIR-7831 After IV Administration |
10.5 | — |
| SECONDARY Part C: Clast of VIR-7831 After IM Administration |
2.6 | — |
| SECONDARY Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration |
0.042; 0.042 | — |
| SECONDARY Part B: Tmax of VIR-7831 After IV Administration |
0.026 | — |
| SECONDARY Part B: Tmax of VIR-7831 After IM Administration |
6.878 | — |
| SECONDARY Part C: Tmax of VIR-7831 After IV Administration |
0.014 | — |
| SECONDARY Part C: Tmax of VIR-7831 After IM Administration |
27.866 | — |
| SECONDARY Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration |
161.333; 162.248 | — |
| SECONDARY Part B: Tlast of VIR-7831 After IV Administration |
167.715 | — |
| SECONDARY Part B: Tlast of VIR-7831 After IM Administration |
167.670 | — |
| SECONDARY Part C: Tlast of VIR-7831 After IV Administration |
162.458 | — |
| SECONDARY Part C: Tlast of VIR-7831 After IM Administration |
168.912 | — |
| SECONDARY Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration |
1355.2; 1738.8 | — |
| SECONDARY Part B: AUCD1-29 of VIR-7831 After IV Administration |
1442.9 | — |
| SECONDARY Part B: AUCD1-29 of VIR-7831 After IM Administration |
686.9 | — |
| SECONDARY Part C: AUCD1-29 of VIR-7831 After IV Administration |
1405.4 | — |
| SECONDARY Part C: AUCD1-29 of VIR-7831 After IM Administration |
327.1 | — |
| SECONDARY Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration |
3982.7; 5238.4 | — |
| SECONDARY Part B: AUC(0-inf) of VIR-7831 After IV Administration |
4449.3 | — |
| SECONDARY Part B: AUC(0-inf) of VIR-7831 After IM Administration |
3194.4 | — |
| SECONDARY Part C: AUC(0-inf) of VIR-7831 After IV Administration |
4255.3 | — |
| SECONDARY Part C: AUC(0-inf) of VIR-7831 After IM Administration |
1441.0 | — |
| SECONDARY Part A: Area Under the Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration |
3456.5; 4528.5 | — |
| SECONDARY Part B: AUClast of VIR-7831 After IV Administration |
3848.5 | — |
| SECONDARY Part B: AUClast of VIR-7831 After IM Administration |
2446.5 | — |
| SECONDARY Part C: AUClast of VIR-7831 After IV Administration |
3492.6 | — |
| SECONDARY Part C: AUClast of VIR-7831 After IM Administration |
1185.8 | — |
| SECONDARY Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration |
14.9; 12.6 | — |
| SECONDARY Part B: %AUCexp of VIR-7831 After IV Administration |
13.1 | — |
| SECONDARY Part B: %AUCexp of VIR-7831 After IM Administration |
15.0 | — |
| SECONDARY Part C: %AUCexp of VIR-7831 After IV Administration |
13.6 | — |
| SECONDARY Part C: %AUCexp of VIR-7831 After IM Administration |
15.0 | — |
| SECONDARY Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration |
63.196; 55.547 | — |
| SECONDARY Part B: t1/2 of VIR-7831 After IV Administration |
55.735 | — |
| SECONDARY Part B: t1/2 of VIR-7831 After IM Administration |
59.347 | — |
| SECONDARY Part C: t1/2 of VIR-7831 After IV Administration |
60.938 | — |
| SECONDARY Part C: t1/2 of VIR-7831 After IM Administration |
61.867 | — |
| SECONDARY Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831 |
12.40; 7.88 | — |
| SECONDARY Part B: Vz of VIR-7831 After IV Administration |
9.97 | — |
| SECONDARY Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration |
18.14 | — |
| SECONDARY Part C: Vz of VIR-7831 After IV Administration |
10.93 | — |
| SECONDARY Part C: Vz/F of VIR-7831 After IM Administration |
20.24 | — |
| SECONDARY Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration |
11.42; 7.47 | — |
| SECONDARY Part B: Vss of VIR-7831 After IV Administration |
9.41 | — |
| SECONDARY Part C: Vss of VIR-7831 After IV Administration |
10.61 | — |
| SECONDARY Part A: Clearance (CL) of VIR-7831 After IV Administration |
136.8; 98.7 | — |
| SECONDARY Part B: CL of VIR-7831 After IV Administration |
120.3 | — |
| SECONDARY Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration |
216.2 | — |
| SECONDARY Part C: CL of VIR-7831 After IV Administration |
130.5 | — |
| SECONDARY Part C: CL/F of VIR-7831 After IM Administration |
237.8 | — |
| SECONDARY Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Three Dose Levels (250 mg IM in Part C, 500 mg IM in Part B and 500 mg IV in Parts B and C) |
5.52; 4.86; 8.40 | — |
| SECONDARY Dose-normalized Least Square Geometric Mean Ratio of AUCinf for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) |
5.56; 4.86 | — |
| SECONDARY Dose-normalized Least Square Geometric Mean Ratio of AUClast for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) |
4.31; 4.05 | — |
| SECONDARY Dose-normalized Least Square Geometric Mean Ratio of AUCD1-D29 for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) |
1.17; 1.06 | — |
| SECONDARY Dose-normalized Least Square Geometric Mean Ratio of Cmax for VIR-7831 Gen2 Between the Two IM Dose Levels (250 mg IM in Part C and 500 mg IM in Part B) |
0.05; 0.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- For Part A, participants must be aged 18 years or older at the time of obtaining informed consent
- For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent
- 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
- 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
- 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)
- For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion
- 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)
Data sourced from ClinicalTrials.gov (NCT04779879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.