COVID-19 Pneumonia Clinical Trial
Official title:
A Phase 1/2 Randomized, Placebo-Controlled Trial of ACT-20 in Patients With Severe COVID-19 Pneumonia
The primary objective of this study is determine the safety and efficacy of ACT-20-MSC (allogenic human umbilical derived mesenchymal stem cells) and ACT-20-CM (allogenic human umbilical derived mesenchymal stem cells in conditioned media) in patients with moderate to severe COVID-19 pneumonia.
This study will assess the safety and efficacy of ACT-20-MSC and ACT-20-CM administered
intravenously to subjects with moderate to severe COVID-19 related pneumonia in two parts.
Part 1 is an open-label study of 10 subjects, 5 with moderate COVID-19 pneumonia and 5 with
severe COVID-19 pneumonia. Of these 10 subjects, 5 will receive ACT-20-CM and 5 will receive
ACT-20-MSC resuspended in ACT-20-CM.
Part 2 is a randomized, blinded, placebo-controlled study of 60 patients, 30 with moderate
COVID-19 pneumonia and 30 with severe COVID-19 pneumonia. Randomization will be 1:1:1
ACT-20-MSC in ACT-20-CM, ACT-20-CM or placebo. The placebo is MEM-α, a widely used sterile
culture media that contains non-essential amino acids, nucleosides, vitamins, glucose, sodium
pyruvate and lipoic acid.
Subjects treated at each investigative site will provide written informed consent prior to
the conduct of any study-related procedures. Thereafter, they will be screened and those
meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the
study procedures including the intravenous administration of the investigational medical
product (IMP = ACT-20-MSC in ACT-20-CM or ACT-20-CM) or placebo. The IMP will be administered
in addition to any standard of care treatment the subject is receiving.
Subjects will be assessed daily while in hospital. Following discharge from hospital,
subjects will be following for an additional three month period.
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