Clinical trial NCT04779879: Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants With Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: SARS-CoV-2
coronavirus
coronavirus disease 2019
COVID-19
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2021-03-03
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Part A: Number of Participants With All Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Day 29
timeFrame: Up to Day 29
measure: Part A: Number of Participants With Adverse Events of Special Interest (AESI) Through Day 29
timeFrame: Up to Day 29
measure: Part A: Number of Participants With Worst-case Post Baseline Abnormal Electrocardiogram (ECG) Findings Through Day 29
timeFrame: Up to Day 29
measure: Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
timeFrame: Up to Day 29
measure: 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)
timeFrame: Day 1 to Day 8
measure: Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 (AUCD1-8)
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Part A: Number of Participants With Non-Serious AEs Through Week 12
timeFrame: Up to Week 12
measure: Part A: Number of Participants With SAEs Through Week 24
timeFrame: Up to Week 24
measure: Part A: Number of Participants With AESI Through Week 24
timeFrame: Up to Week 24
measure: Part A: Number of Participants With Abnormal ECG Findings at Indicated Time Points
timeFrame: Days 1, 5, 11 and 85 (Week 12)
measure: Part A: Number of Participants With Disease Progression Events (Disease-Related Events) Through Week 24
timeFrame: Up to Week 24
measure: Part B: Number of Participants With All AEs and SAEs Through Day 29
timeFrame: Up to Day 29
measure: Part B: Number of Participants With AESI Through Day 29
timeFrame: Up to Day 29
measure: Part B: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
timeFrame: Up to Day 29
measure: Part B: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
timeFrame: Up to Day 29
measure: Part C: Number of Participants With All AEs and SAEs Through Day 29
timeFrame: Up to Day 29
measure: Part C: Number of Participants With AESI Through Day 29
timeFrame: Up to Day 29
measure: Part C: Number of Participants With Worst-case Post Baseline Abnormal ECG Findings Through Day 29
timeFrame: Up to Day 29
measure: Part C: Number of Participants With Disease Progression Events (Disease-Related Events) Through Day 29
timeFrame: Up to Day 29
measure: Part B: Number of Participants With Non-Serious AEs Through Week 12
timeFrame: Up to Week 12
measure: Part B: Number of Participants With SAEs Through Week 36
timeFrame: Up to Week 36
measure: Part B: Number of Participants With AESI Through Week 36
timeFrame: up to Week 36
measure: Part B: Number of Participants With Abnormal ECG Findings at Indicated Time Points
timeFrame: Days 1, 5, 11 and 85 (Week 12)
measure: Part B: Number of Participants With Disease Progression Events Through Week 36
timeFrame: Up to Week 36
measure: Part C: Number of Participants With Non-Serious AEs Through Week 12
timeFrame: Up to Week 12
measure: Part C: Number of Participants With SAEs Through Week 36
timeFrame: Up to Week 36
measure: Part C: Number of Participants With AESI Through Week 36
timeFrame: Up to Week 36
measure: Part C: Number of Participants With Abnormal ECG Findings at Indicated Time Points
timeFrame: Days 1, 5, 11 and 85 (Week 12)
measure: Part C: Number of Participants With Disease Progression Events Through Week 36
timeFrame: Up to Week 36
measure: Part A: Change From Baseline in SARS-CoV-2 Saliva and Nasal Mid-Turbinate Viral Load
timeFrame: Baseline, Days 2, 5, 8, 11, 15, 22 and 29
measure: Part B: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
timeFrame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
measure: Part C: Change From Baseline in Viral Load as Measured by qRT-PCR From Nasopharyngeal Swab Samples
timeFrame: Baseline, Days 2, 3, 5, 8, 11, 15, 22 and 29
measure: Part B: Percentage of Participants With Undetectable Viral Load
timeFrame: Days 2, 3, 5, 8, 11, 15, 22 and 29
measure: Part C: Percentage of Participants With Undetectable Viral Load
timeFrame: Days 2, 3, 5, 8, 11, 15, 22 and 29
measure: Part B: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
timeFrame: Day 1 to Day 5
measure: Part B: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
timeFrame: Day 1 to Day 11
measure: Part C: Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 5 (AUCD1-5)
timeFrame: Day 1 to Day 5
measure: Part C: Mean Area Under the Curve (AUC) of SARS-CoV-2 Viral Load From Day 1 to Day 11 (AUCD1-11)
timeFrame: Day 1 to Day 11
measure: Part B: Percentage of Participants With a Persistently High Viral Load at Day 8
timeFrame: Day 8
measure: Part C: Percentage of Participants With a Persistently High Viral Load at Day 8
timeFrame: Day 8
measure: Part A: Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Cmax of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Cmax of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Cmax of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: Cmax of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Concentration at Last Quantifiable Time-point (Clast) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Clast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Clast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Clast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: Clast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Time to Reach Cmax (Tmax) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Tmax of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Tmax of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Tmax of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: Tmax of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Tlast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Tlast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Tlast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: Tlast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: AUC From Day 1 to 29 (AUCD1-29) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29
measure: Part B: AUCD1-29 of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
measure: Part B: AUCD1-29 of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
measure: Part C: AUCD1-29 of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
measure: Part C: AUCD1-29 of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
measure: Part A: Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUC[0-inf]) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: AUC(0-inf) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: AUC(0-inf) of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: AUC(0-inf) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: AUC(0-inf) of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: 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
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: AUClast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: AUClast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: AUClast of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: AUClast of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Percentage of AUC(Infinity) Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: %AUCexp of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: %AUCexp of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: %AUCexp of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: %AUCexp of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: t1/2 of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: t1/2 of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: t1/2 of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: t1/2 of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Apparent Volume of Distribution During the Elimination Phase Following Intravascular Administrtion (Vz) of VIR-7831
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Vz of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Apparent Volume of Distribution During the Elimination Phase Following Extravascular Administration (Vz/F) of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Vz of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: Vz/F of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: Vss of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: Vss of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part A: Clearance (CL) of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion and at 1, 2, 6, and 8 hours following end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, and 169 (+/-12 days)
measure: Part B: CL of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part B: Apparent Clearance (CL/F) of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-7 days)
measure: Part C: CL of VIR-7831 After IV Administration
timeFrame: Day 1: Pre-dose, end of infusion; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: Part C: CL/F of VIR-7831 After IM Administration
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: 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)
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: 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)
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: 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)
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
measure: 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)
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29 (+/-2 days)
measure: 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)
timeFrame: Day 1: Pre-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 141, and 169 (+/-18 days)
Other outcomes:
measure: Part A: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part B: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part C: Number of Participants With Presence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part A: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part B: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part C: Number of Participants With Emergence of SARS-CoV-2 Viral Resistance Mutants Against VIR-7831
timeFrame: Up to Day 28
measure: Part A: Number of Participants With the Presence of Anti-VIR-7831 Antibody
timeFrame: Up to Week 24
measure: Part B: Number of Participants With the Presence of Anti-VIR-7831 Antibody
timeFrame: Up to Week 24
measure: Part C: Number of Participants With the Presence of Anti-VIR-7831 Antibody
timeFrame: Up to Week 24
measure: Part A: Titers of Anti-drug Antibody to VIR-7831
timeFrame: Up to Week 24
measure: Part B: Titers of Anti-drug Antibody to VIR-7831
timeFrame: Up to Week 24
measure: Part C: Titers of Anti-drug Antibody to VIR-7831
timeFrame: Up to Week 24
measure: Part A: Number of Participants With the Presence of Anti-nucleocapsid (Anti-N), Anti-spike (Anti-S) and Anti-Receptor Binding Domain (Anti-RBD) SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part B: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part C: Number of Participants With the Presence of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part A: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part B: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part C: Titers of Anti-N, Anti-S and Anti-RBD SARS-CoV-2 Antibodies at Baseline
timeFrame: Baseline (Day 1)
measure: Part A: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
measure: Part B: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
measure: Part C: Number of Participants With the Presence of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
measure: Part A: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
measure: Part B: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
measure: Part C: Titers of Anti-N SARS-CoV-2 Antibodies at Day 29
timeFrame: Day 29
Locations:
city: Anniston
country: United States
facility: Investigative Site
state: Alabama
city: Bakersfield
country: United States
facility: Investigative Site
state: California
city: Northridge
country: United States
facility: Investigative Site
state: California
city: Fort Pierce
country: United States
facility: Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: Columbus
country: United States
facility: Investigative Site
state: Georgia
city: Winfield
country: United States
facility: Investigative Site
state: Illinois
city: Rockville
country: United States
facility: Investigative Site
state: Maryland
city: Bronx
country: United States
facility: Investigative Site
state: New York
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Sarnia
country: Canada
facility: Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Investigative Site
state: Ontario
city: Milano
country: Italy
facility: Investigative Site
city: Daejeon
country: Korea, Republic of
facility: Investigative Site
city: Alicante
country: Spain
facility: Investigative Site
city: Barcelona
country: Spain
facility: Investigative Site
city: Centelles
country: Spain
facility: Investigative Site
city: Granada
country: Spain
facility: Investigative Site
city: La Roca Del Vallès
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Pozuelo De Alarcón
country: Spain
facility: Investigative Site
city: Vigo
country: Spain
facility: Investigative Site
Study officials:
References:
citation: Kreuzberger 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.