AV-001 for Hospitalized Patients With COVID-19 Disease
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
A Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation study in patients
hospitalized with confirmed severe coronavirus disease 2019 (COVID-19). The purpose of this
study is to examine the safety, tolerability and efficacy of AV-001 Injection administration
daily to the earlier of day 28 or EOT (day prior to hospital discharge) to patients with
severe COVID-19 disease. A total of 120 eligible patients (20 patients in each of cohort 1, 2
and 3 and 60 patients in cohort 4) will be recruited from up to 20 participating
institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001
Injection or AV-001 placebo Injection, together with standard of care (SOC).