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Cochrane COVID-19 Study Register
Study record
NCT04370262First Published: 2020 Apr 30Updated Date: 2021 Nov 5

A Multi-site, Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Standard of Care (SOC) Plus Famotidine vs SOC Plus Placebo for the Treatment of COVID-19 in Hospitalized Adults

  1. Study Type
  2. Interventional
  3. Adaptive/Platform
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (7)
  2. Male and Female
  3. COVID-19
  4. Adult
  5. Aged (65+)
  1. Intervention (2)
  2. Usual Care
  3. Famotidine
  1. Comparison (2)
  2. Usual Care
  3. Placebo
  1. Outcome (8)
  2. Lymphopenia
  3. Oxygen Supplementation
  4. SARS-CoV-2 Virus
  5. Hospitalization
  6. Death
  7. Mechanical ventilation
  8. National Early Warning Score
  9. COVID-19 Ordinal Outcomes Scale
Reference record

Multi-site Adaptive Trials for COVID-19

NCT04370262
First Published (first received 2020 April 30)ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT04370262)
Trial registry record
No Results
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
Reference record

Famotidine Use is Associated with Improved Clinical Outcomes in Hospitalized COVID-19 Patients: a Retrospective Cohort Study

Freedberg DE, Conigliaro J, Sobieszczyk ME, Markowitz DD, Gupta A, Donnell MR, Li J, Tuveson DA, Jin Z, Turner WC, Landry DW, Wang TC, Tracey KJ, Callahan MV, Abrams JA
Unpublished article (preprint)
Report Results
Background: The SARS-CoV-2 pandemic has resulted in enormous morbidity and mortality worldwide, yet no medications to date are proven to improve clinical outcomes in hospitalized COVID-19 patients. Famotidine is commonly used for gastric acid suppression but also has recently gained attention as an antiviral that may inhibit SARS-CoV-2 replication. Objective: To determine whether famotidine use is associated with improved clinical outcomes in patients with COVID-19 initially hospitalized to a non-intensive care setting. Design: Retrospective cohort study. Setting: Inpatients at a single academic medical center. Participants: Consecutive hospitalized patients with COVID-19 infection from February 25 to April 13, 2020. Measurements: Famotidine use (exposure); intubation or death (primary outcome) Results: 1,620 hospitalized patients with COVID-19 were analyzed including 84 (5.1%) who received famotidine within 24 hours of hospital admission. There were no differences between famotidine users and non-users in age, body mass index, or comorbidities including diabetes or hypertension. 340 (21%) patients met the study composite outcome of death or intubation. Use of famotidine was associated with reduced risk for death or intubation (adjusted hazard ratio (aHR) 0.40, 95% CI 0.20-0.81) and also with reduced risk for death alone (aHR 0.29, 95% CI 0.11-0.78). Proton pump inhibitors, which also suppress gastric acid, were not associated with reduced risk for death or intubation. In patients without COVID-19 hospitalized during the same time period, no association was observed between use of famotidine and death or intubation. Limitations: Retrospective analysis; non-randomized exposure. Conclusion: Famotidine use is associated with reduced risk of intubation or death in hospitalized COVID-19 patients. Randomized controlled trials are warranted to determine whether famotidine therapy improves outcomes in hospitalized COVID-19 patients.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was unfunded.Author DeclarationsAll relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.YesAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData will be made available by the corresponding author upon request, with appropriate safeguards for patient privacy. Preprints are preliminary reports of work that have not been peer reviewed. Refer to the original preprint or preprint server for specific information about the individual preprint