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Posted On: 08/16/2020 3:14:33 PM
Post# of 153897
Re: clambottler #49916
Enrollment ratio is 2:1. They missed to clarify this in the clinicaltrials.gov entry.
Also, patients will be able to continue to receive drugs that are considered SOC:
"Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care."
See in the PRs:
"CD-12 is a Phase 3 randomized, double blind, placebo controlled, adaptive design multicenter two arm study to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients are randomized 2:1 (two leronlimab: one placebo) to receive weekly doses of 700 mg leronlimab or placebo via subcutaneous injection."
And on website:
"Also, CytoDyn has the approval to proceed with a Phase 2b/3 trial for 390 severely ill COVID-19 patients. This study is a double-blinded study with a 2:1 ratio (a drug to placebo ratio)."
Also, patients will be able to continue to receive drugs that are considered SOC:
"Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care."
See in the PRs:
"CD-12 is a Phase 3 randomized, double blind, placebo controlled, adaptive design multicenter two arm study to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients are randomized 2:1 (two leronlimab: one placebo) to receive weekly doses of 700 mg leronlimab or placebo via subcutaneous injection."
And on website:
"Also, CytoDyn has the approval to proceed with a Phase 2b/3 trial for 390 severely ill COVID-19 patients. This study is a double-blinded study with a 2:1 ratio (a drug to placebo ratio)."
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