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Posted On: 03/22/2021 2:06:08 PM
Post# of 154895
Re: melsdollars #83868
This is from CD12_COVID-19
This might be the explanation. We are in an open-label phase. Single arm. After completion of enrollment in the Randomized Phase of the Study.
Clear and plain English. The green quote was added to the trial.
So, we are in OLE under Follow-Up Period .... with new criteria for enrollment. But under Severe-Critical trial (with Critical criteria).
Does it make sense ??
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.
A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
This might be the explanation. We are in an open-label phase. Single arm. After completion of enrollment in the Randomized Phase of the Study.
Clear and plain English. The green quote was added to the trial.
So, we are in OLE under Follow-Up Period .... with new criteria for enrollment. But under Severe-Critical trial (with Critical criteria).
Does it make sense ??
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