Safety, tolerability, pharmacokinetics, and pharmacodynamics of second generation VIR-7831 material administered intravenously (IV) and intramuscularly (IM) in non-hospitalized participants with mild to moderate coronavirus disease 2019 (COVID-19)
- 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: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000724-35-IT
- Lead Sponsor
- Vir Biotechnology, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Age
Part A: The participant must be 18 years of age or older at the time of signing the informed consent.
- Part B and C: Participants must be =18 years of age and <70 at the time of obtaining informed consent. The additional restriction of age <70 years for Part B and C is for logistical purposes, due to the fact that the present study and the COMET-TAIL study (a study that will administer VIR-7831 via IM injection whose planning is currently underway), which are enrolling similar populations (non-hospitalised patients with mild to moderate COVID-19), may use many of the same centres to enrol participants. The COMET-TAIL study, which requires a participant to be at high risk for progression to severe disease and/or aged =55 years, will enrich enrollment for participants aged 70 years or older.
Type of participants and disease characteristics
2. Participants who have a positive SARS-CoV-2 test result (by any validated test, e.g. RT-PCR) = 7 days prior to enrolment and oxygen saturation =94% in room air and have at least one of the following symptoms from COVID-19: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, altered sense of smell and taste, vomiting, diarrhoea, dyspnoea on exertion and = since onset of symptoms
Requirements for sexual intercourse and contraceptive/barrier methods
3. No gender restrictions
4. Female participants should meet and agree to meet the following criteria related to contraception. The use of contraceptives consistent with local regulations regarding methods of contraception for those participating in clinical trials.
A female participant is eligible for participation if she is not pregnant or lactating, and if any of the following conditions apply:
a. she is a Woman of Non-Chilbearing Potential (WONCBP) as defined in Section 10.4 of the Protocol
b. She is a Woman of Childbearing Potential (WOCBP) and is using a highly effective contraceptive method with a failure rate of <1% as described in Section 10.4 of the Protocol during the study treatment period up to 24 weeks after the last administration of the study treatment. The investigator should assess the potential for failure of the contraceptive method (e.g., non-adherence, recent onset) in relation to the administration of the first dose of study treatment.
A WOCBP should have a negative high sensitivity pregnancy test (on urine or serum as required by local regulations) prior to the first administration of study treatment. Refer to Section 8.4.7 Pregnancy Testing of the Protocol.
- If a urine pregnancy test cannot be confirmed as negative (e.g. the result is ambiguous), a serum pregnancy test is required. In such cases, the participant shall be excluded from participation if the result of the serum pregnancy test is positive.
- Section 1.3 of the Protocol contains additional requirements for pregnancy testing during and after study treatment.
The investigator is responsible for reviewing the history, menstrual history and recent sexual activity in order to decrease the risk of including a woman with an undetected early pregnancy.
Informed Consent
5.Able to give signed informed consent as described in section
10.1.3 of the protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
O
If participants are unable to give written informed consent,
alternative consent procedures will be followed as described in section
10.1.3 of the proto
Medical conditions
1. patients currently hospitalised or judged by the investigator to be likely to require hospitalisation in the next 24 hours.
2. Symptoms consistent with severe COVID-19 identified by: shortness of
Symptoms consistent with severe COVID-19 identified by: shortness of breath at rest, difficulty breathing or need for supplemental oxygen.
3.Participants judged by the investigator to be likely to die within the next 7 days.
4. Severely immunocompromised participants, including but not limited to
cancer patients undergoing 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 transplantation, or administration of long-term high dose corticosteroid therapy (equivalent to =20 mg per day of prednisone or the systemic equivalent for more than 2 weeks).
5. Known hypersensitivity to any component present in the investigational product.
6. Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
7. For Part B and Part C of the trial
- The participant, in the opinion of the investigator, has conditions for which he/she cannot receive intramuscular injections, e.g. coagulation disorders, haemorrhagic diathesis, or thrombocytopenia.
- Previous/current participation in another clinical trial
8. Enrollment in any study with investigational vaccines within the last 180 days or in any other study with an investigational drug within 30 days prior to Day 1 or within 5 half-lives of the investigational product, whichever is longer.
9. Enrollment in any study of an investigational vaccine for SARS-CoV-2.
Other exclusions
10. The following vaccination-related exclusions apply:
a. Part A and Part B only: Receipt of a SARS-CoV-2 vaccine at any time. Vaccination with a licensed and approved SARS-CoV-2 vaccine will not be allowed for 90 days following treatment.
NOTE TO PART C: Having received a licensed and approved SARS-CoV-2 vaccine is NOT an exclusion criterion.
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 administration.
11.Receipt of convalescent plasma from a patient cured of COVID-19 or
mAb anti SARS-CoV-2 within the last 3 months.
12.Participants who, in the opinion of the investigator, will not meet the protocol requirements until day 29.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method