Multi-site Adaptive Trials Using Pepcid, Hydroxycholoroquine for COVID-19

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Brief Summary:

The overall objective of the study will be to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC) combined with pharmaceutical antiviral management using hydroxychloroquine, or SOC with hydroxychloroquine combined with high-dose intravenous famotidine, in hospitalized patients meeting nucleic acid diagnostic and radiologic criteria for COVID-19 disease. The trial will statistically compare the clinical benefit afforded by the two treatment strategies to internal historical “standard of care” data from Northwell patents treated without benefit of either hydroxychloroquine or high-dose famotidine. We will compare clinical outcomes associated with hydroxychloroquine and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 600 COVID-19 patients hospitalized with moderate to severe disease into each of the two active treatment arms, with a total enrollment target of at least 1200 patients. The proposed trial has been designed for rapid enrollment and completion and powered to support two interim analyses that will enable prompt assessment of benefits and risks of the two treatment groups while maintaining the rigorous gold standard of a randomized double blind clinical trial structure. Trial design has been guided by practical consideration of the current clinical context involving rapidly escalating demands on hospital staff and resources, and incorporates a minimalist approach employing existing laboratory information management systems and a clinically relevant binary primary outcome of 30-day endpoint of death or survival.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: HCQ + Intravenous FamotidineDrug: HCQ + Placebo	Phase 3

Study Type :	Interventional  (Clinical Trial)
Estimated Enrollment :	1170 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Randomized, Double-Blind, Multi-Arm Historical Control, Comparative Trial
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multi-site, Randomized, Double-Blind, Multi-Arm Historical Control, Comparative Trial of the Safety and Efficacy of Hydroxychloroquine, and the Combination of HCQ and Famotidine for the Treatment of COVID-19
Actual Study Start Date :	April 7, 2020
Estimated Primary Completion Date :	September 7, 2020
Estimated Study Completion Date :	April 7, 2021

https://clinicaltrials.gov/ct2/show/NCT04370262