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 |
