Clazakizumab (Anti-IL- 6 Monoclonal) Compared to Placebo for COVID19 Disease
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a single center, randomized, double-blind, placebo-controlled, exploratory phase II
study enrolling 60 patients. We propose the administration of a blinded dose of an
investigational product (IP) (clazakizumab or placebo[0.9% saline]) in patients with COVID-19
disease and signs of pulmonary involvement who have not yet required mechanical ventilation
and/or ECMO. If a patient progresses to mechanical ventilation and/or ECMO or develops
clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious
adverse events(SAEs), within the initial 14 day period after the first dose of the IP, at the
discretion of the investigator or treating physician, open-label clazakizumab 25mg IV X 1
dose may be administered. A minimum of 24 hours should elapse between the first dose of IP
and this dose of open-label clazakizumab. The patient will remain blinded as to the identity
of the IP administered in the first dose.