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NCT04370262 · ClinicalTrials.gov registry record · Phase 3
Multi-site Adaptive Trials for COVID-19
A Phase 3 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT04370262 is a Phase 3 study that has completed, run by Northwell Health. The registered enrollment target is 233 participants.
The verdict
NCT04370262, a Phase 3 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
The overall objective of the study is to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients hospitalized and meeting radiologic criteria for COVID-19 disease. SOC for the treatment for COVID-19 has evolved since the initial conceptualization of this protocol and early recruitment of patients. Initially SOC included hydroxychloroquine and has progressed to include Remdesivir. This protocol is amended to allow the SOC to reflect the prevailing treatment for COVID-19. We will compare clinical outcomes associated with SOC and the addition of high-dose intravascular famotidine. The trial is designed to enroll at least 471 COVID-19 patients hospitalized with moderate to severe disease into each of the two treatment arms, with a total enrollment target of at least 942 patients. This trial has been designed and powered to support up to three 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.
Interventions
- DRUG SOC + Intravenous Famotidine
- DRUG SOC + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2020-09-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04370262
The ClinicalTrials.gov registry entry for NCT04370262 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 233 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SOC + Intravenous Famotidine is the first listed.
NCT04370262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04370262 about?
NCT04370262 is a clinical study titled "Multi-site Adaptive Trials for COVID-19". The overall objective of the study is to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients hospitalized and meeting radiologic criteria for COVID-19 disease. SOC for the treatment for COVID-19 has evolved since th...
What is the current status of trial NCT04370262?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2020-04-07. Estimated completion is 2020-09-07.
What interventions are being tested in trial NCT04370262?
The interventions under investigation include: SOC + Intravenous Famotidine (DRUG), SOC + Placebo (DRUG).
Who is sponsoring clinical trial NCT04370262?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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