A RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF MONOCLONAL ANTIBODY VIR-7831 FOR THE EARLY TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED PATIENTS
- Conditions
- -B342 Coronavirus infection, unspecified siteCoronavirus infection, unspecified siteB342
- Registration Number
- PER-095-20
- Lead Sponsor
- Vir Biotechnology, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 1
1. Participant must be aged 18 years or older AND at high risk of progression of
COVID-19 based on presence of one or more of the following risk factors:
diabetes (requiring medication), obesity (BMI>30), chronic kidney disease
(i.e., eGFR <60 by MDRD), congestive heart failure (NYHA class II or more),
chronic obstructive pulmonary disease (history of chronic bronchitis, chronic
obstructive lung disease, or emphysema with dyspnea on physical exertion), and
moderate to severe asthma (participant requires an inhaled steroid to control
symptoms or has been prescribed a course of oral steroids in the past year)
OR
2. Participant ≥ 55 years old, irrespective of co-morbidities.
3. Participants who have a positive SARS-CoV-2 test result (by any validated test
e.g. RT-PCR on any specimen type)
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
Less than or equal to 5 days from onset of symptoms.
4. No gender restrictions
5. 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.
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 24 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 8.3.7 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.
6. Capable of giving signed informed consent as described in Section 10.1 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.
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 ≥ 20mg 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. 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 half-lives of the investigational compound, whichever is longer.
8. Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
9. Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not
be allowed for 4 weeks after dosing.
10. Receipt of convalescent plasma from a recovered COVID-19 patient or
anti-SARS-CoV-2 mAb within the last 3 months.
11. 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:1. Hospitalization > 24 hours for acute<br>management of illness<br>OR<br>2. Death<br>Measure:Proportion of participants who have<br>progression of COVID-19 through Day<br>29 as defined by:<br>1. Hospitalization > 24 hours for acute<br>management of illness<br>OR<br>2. Death<br>Timepoints:Up to day 29<br>
- Secondary Outcome Measures
Name Time Method