COVID-19 Clinical Trial
Official title:
A Randomized, Open Label, Controlled Clinical Study to Evaluate the Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) in Adult Patients With COVID-19
This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.
This is a small pilot study investigating whether there is any efficacy signal that warrants
a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It
is not expected to produce statistically significant results in the major endpoints. The
investigators will examine all of the biologic, physiological, and clinical data to determine
whether a Phase 2B trial is warranted.
Primary efficacy analysis will be carried only on patients receiving at least 4 doses of
active drug. Safety analysis will be carried out on all patients receiving at least one dose
of active drug.
It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to
have at least 12 evaluable patients in each group.
Experimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of
care
Intervention duration: up to 7 days of therapy
No planned interim analysis.
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