Beautiful. Thank you. I had missed that. Deta
Post# of 148147
(Total Views: 632)
Posted On: 09/18/2020 10:21:35 PM
Beautiful. Thank you. I had missed that.
There is MUCH, MUCH more leeway in what data can be shared at interim analysis that won't compromise the study or it's full term results....as long as it was written into the protocol.
Quote:
Detailed Description:
This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
There is MUCH, MUCH more leeway in what data can be shared at interim analysis that won't compromise the study or it's full term results....as long as it was written into the protocol.
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