Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
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| ClinicalTrials.gov Identifier: NCT04913675 |
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Recruitment Status :
Active, not recruiting
First Posted : June 4, 2021
Results First Posted : May 26, 2023
Last Update Posted : May 26, 2023
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Sponsor:
Vir Biotechnology, Inc.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vir Biotechnology, Inc.
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Brief Summary:
The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim is the evaluation of the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Covid19 | Biological: sotrovimab Biological: Sotrovimab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | June 10, 2021 |
| Actual Primary Completion Date : | July 19, 2022 |
| Estimated Study Completion Date : | July 24, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
Drug Information available for:
Sotrovimab
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Main Study - Sotrovimab 500 mg IV |
Biological: sotrovimab
Sotrovimab 500 mg given by intravenous infusion over 15 min |
| Experimental: Main Study - Sotrovimab 500 mg IM |
Biological: sotrovimab
Sotrovimab 500 mg given by intramuscular injection |
| Experimental: Main Study - Sotrovimab 250 mg IM |
Biological: sotrovimab
Sotrovimab 250 mg given by intramuscular injection |
| Experimental: Substudy (Cohort A) - Sotrovimab 2000 mg IV |
Biological: sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 60 min |
| Experimental: Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV |
Biological: Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 30 min |
| Experimental: Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV |
Biological: Sotrovimab
Sotrovimab 2000 mg given by intravenous infusion over 15 min |
| Experimental: Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV |
Biological: Sotrovimab
Sotrovimab up to 3000 mg given by intravenous infusion over 90 min |
Primary Outcome Measures :
- Number of Participants Who Had Progression of COVID-19 Through Day 29 by Hospitalization >24 Hours or Death Due to Any Cause [ Time Frame: Up to Day 29 ]Progression of COVID-19 through Day 29 as defined by hospitalization >24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.
Secondary Outcome Measures :
- Number of Participants With Common Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 36 ]An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, significant medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed before. Adverse events which were not serious were considered as non-serious adverse events. Common (>=1%) non-SAEs and SAEs are presented.
- Number of Participants With Any Infusion- or Injection-related Reaction Including Hypersensitivity [ Time Frame: Up to Week 36 ]Data for number of participants with any infusion- or injection-related reaction including hypersensitivity has been presented.
- Number of Participants With Any Local Site Reaction by Maximum Severity After IM Administration [ Time Frame: Up to Week 36 ]An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included any solicited local site reactions. AESI were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007, Food and Drug Administration, where Grade 1=Mild toxicity; Grade 2=Moderate toxicity; Grade 3=Severe toxicity; and Grade 4= Potentially life-threatening toxicity. Higher Grade indicates higher severity. Data for any worst case post-Baseline has been presented.
- Number of Participants With Any Disease Related Events [ Time Frame: Up to Week 36 ]AEs related to expected progression, signs, or symptoms of COVID-19, unless more severe than expected for the participant's current clinical status and medical history, were reported as a disease related events.
- Number of Participants With Treatment-emergent Positive Anti-drug Antibody [ Time Frame: Up to Week 24 ]Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample.
- Titers of Anti-drug Antibodies Against Sotrovimab [ Time Frame: Up to Week 24 ]Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD. Titer Median and range from treatment emergent and unaffected are described below. Immunogenicity results were categorized as treatment- induced, treatment-boosted, and treatment-unaffected. Treatment-induced=those who are ADA negative or missing data at baseline and who have at least one post-dose ADA positive sample; Treatment boosted=those who are ADA positive at baseline and have a >4*Baseline titer; Treatment unaffected=those who are positive at baseline and post-Baseline titer <=4*Baseline titer or all post- Baseline negative. Treatment emergent = treatment induced or treatment boosted.
- Number of Participants Who Had Progression of COVID-19 Through Day 29 by Emergency Room Visit or Hospitalization or Death (Weekly Imputation) [ Time Frame: Up to Day 29 ]Progression of COVID-19 through Day 29 as defined by visit to a hospital emergency room for management of illness or hospitalization for acute management of illness for any duration and for any cause or death. Percentage values are rounded off.
- Number of Participants Who Progress to Develop Severe and/or Critical Respiratory COVID-19 by Visit [ Time Frame: Day 8, Day 15, Day 22, and Day 29 ]Participants were defined as progressing to develop 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 progressing to develop critical respiratory COVID-19 if they required invasive mechanical ventilation or extracorporeal membrane oxygenation. Percentage values are rounded off.
- Mean Area Under the Curve (AUC) of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Viral Load From Day 1 to Day 8 [ Time Frame: Day 1 to Day 8 ]AUC of SARS-CoV-2 viral load was measured by Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 in nasopharyngeal swab samples.
- Mean AUC of SARS-CoV-2 Viral Load From Day 1 to Day 8 After Administration of Sotrovimab 500 mg IV and IM [ Time Frame: Day 1 to Day 8 ]AUC of SARS-CoV-2 viral load was measured by qRT-PCR from Day 1 to Day 8 in nasopharyngeal swab samples. Least squares geometric mean and 90 percent (%) confidence interval has been presented.
- Change From Baseline in Viral Load as Measured by qRT-PCR at Day 8 [ Time Frame: Baseline (Day 1) and at Day 8 ]Viral load was based on nasopharyngeal swab samples and was measured by qRT-PCR. Baseline was defined as the latest non-missing value prior to dosing (or latest value on or prior to nominal Day 1 for participants that were not dosed). Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
- Percentage of Participants With Persistently High SARS-CoV-2 Viral Load at Day 8 [ Time Frame: At Day 8 ]Percentage of participants with a persistently high viral load were categorized as >=4.1 log10 copies/mL and <4.1 log10 copies/mL. Percentage of participants with a persistently high SARS-CoV-2 viral load at Day 8 was assessed via qRT-PCR in nasopharyngeal swab samples. Percentage values are rounded off.
- Serum Concentration of Sotrovimab After Intravenous Administration [ Time Frame: Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24 ]Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Sotrovimab.
- Serum Concentration of Sotrovimab After Intramuscular Administration [ Time Frame: Day 1: Pre-dose, Day 8, Day 15, Day 29, Week 12, Week 20 and Week 24 ]Blood samples were collected at indicated time points for PK analysis of Sotrovimab.
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Main Study participant must be aged 12 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
- Sub-Study participants must be aged 18 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04913675
Locations
Show 50 study locations
Sponsors and Collaborators
Vir Biotechnology, Inc.
GlaxoSmithKline
Study Documents (Full-Text)
Documents provided by Vir Biotechnology, Inc.:
Documents provided by Vir Biotechnology, Inc.:
Study Protocol [PDF] October 4, 2021
Statistical Analysis Plan [PDF] October 19, 2021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vir Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT04913675 |
| Other Study ID Numbers: |
VIR-7831-5008 |
| First Posted: | June 4, 2021 Key Record Dates |
| Results First Posted: | May 26, 2023 |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Vir Biotechnology, Inc.:
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SARS-CoV-2 coronavirus disease 2019 COVID-19 early treatment |
Additional relevant MeSH terms:
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Sotrovimab Antiviral Agents Anti-Infective Agents |