Last updated: February 3, 2023
Sponsor: AB Science
Overall Status: Active - Recruiting
Phase
2
Condition
Covid-19
Sars-cov-2
Treatment
N/AClinical Study ID
NCT05047783
AB21002
2021-002620-20
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Male or non-pregnant female with: A. Symptomatic ambulatory male or non-pregnant femaleadult ≥ 18 years of age at time of enrolment with mild COVID-19 with score 2 or 3 of the 10-score WHO clinical progression scale OR B. Hospitalized male or non-pregnant femaleadult ≥ 18 years of age at time of enrolment with COVID-19 with score 4 or 5 of the 10-score WHO clinical progression scale.
- Symptoms consistent with COVID-19, as determined by investigator, with onset ≤5 daysbefore randomization
- Positive test for COVID-19 ≤72 hours prior to randomization
- Negative test for the IgG anti-SARS-CoV-2
Exclusion
Key Exclusion Criteria:
- Any use of anti-viral medications up to 7 days before participating in the study
- Receipt of plasma from a person who recovered from COVID-19 (convalescent plasma) anytime before participating in the study
- Receipt of last recommended dose of a SARS-CoV-2 vaccine up to 30 days beforeparticipating in the study
- Receipt of a monoclonal antibodies up to 30 days before participating in the study. Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Total Participants: 78
Study Start date:
November 23, 2021
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Intensive Care Unit, CHU Gabriel-Montpied
Clermont-Ferrand,
FranceSite Not Available
Gabrichevsky Institute of Epidemiology and Microbiology
Moscow,
Russian FederationActive - Recruiting
Scientific Research Center Eco-Safety
Saint Petersburg,
Russian FederationActive - Recruiting
City Clinical Hospital No. 14
Yekaterinburg,
Russian FederationActive - Recruiting
Netcare Jakaranda Hospital
Pretoria, Gauteng
South AfricaActive - Recruiting
Langeberg Clinical Trials
Cape Town, Western Cape
South AfricaActive - Recruiting
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