A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of VIR-7831 in Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Phase 1

• Conditions: on-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19); MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000724-35-ES
• Lead Sponsor: Vir Biotechnology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-29
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

Age
1. Part A: Participant must be aged 18 years or older at the time of obtaining informed consent.
Part B and C: Participant must be aged =18 years to <70 years at the time of obtaining informed consent. The additional age restriction of <70 years for Part B and C is for logistical purposes such that this study and the COMET-TAIL study (a study administering VIR-7831 via IM injection for which planning is currently ongoing), which are enrolling similar populations (non-hospitalized patients with mild to moderate COVID-19), can utilize many of the same sites for participant enrollment. The COMET-TAIL study, which requires that a participant is at high risk for progression to severe disease and/or =55 years of age, will be enrichingenrollment for participants =70 years of age or older.

Type of Participant and Disease Characteristics
2. Participants who have a positive SARS-CoV-2 test result (by any validated test e.g. RT-PCR on any respiratory type) =7 days prior to enrollment
AND
Oxygen saturation =94% on room air
AND
Have COVID-19 defined by one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertion
AND
=7 days from onset of symptoms
Sex and Contraceptive/Barrier Requirements
3. No gender restrictions
4. Female participants must meet and agree to abide by the following contraceptive criteria. Contraception use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
a. Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4 del Protocolo
OR
b. Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 of the protocol during the study intervention period and for up to 36 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. See Section 8.4.7 Pregnancy Testing of the protocol.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Additional requirements for pregnancy testing during and after study intervention are located in Section 1.3 of the protocol.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an
early undetected pregnancy.
Informed Consent
5. Capable of giving signed informed consent as described in Section 10.1.3 del protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. OR If participants are not capable of giving written informed consent, alternative consent procedures will be followed as described in Section 10.1.3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 ye

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours.
2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen.
3. Participants who, in the judgement of the investigator are likely to die in the next 7 days.
4. Severely immunocompromised participants including but not limited to cancer patients receiving immunosuppressive chemotherapy or immunotherapy, those with a solid organ transplant or allogeneic stem cell transplant within the last 3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to =20 mg a day of prednisone or the systemic equivalent for over 2 weeks).
5. Known hypersensitivity to any constituent present in the investigational product.
6. Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
7. For Part B and Part C of the study – Participant has any condition that would prohibit receipt of intramuscular injections in the investigator’s opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia
Prior/ Concurrent Clinical Study Experience
8. Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 halflives of the investigational compound, whichever is longer.
9. Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
Other Exclusions
10. The following exclusions related to vaccination are applicable:
a. Part A and Part B only: Prior receipt of a SARS-CoV-2 vaccine at any time. Vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing.
NOTE FOR PART C : Previous receipt of an authorized or approved SARS-CoV-2 vaccine is NOT an exclusion criteria.
b. Part A, Part B, and Part C: Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not be allowed for 90 days after dosing.
11. Receipt of convalescent plasma from a recovered COVID-19 patient or anti- SARS-CoV-2 mAb within the last 3 months.
12. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified