Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19

April 4, 2022 updated by: Tobias Janowitz, Northwell Health

A Randomized, Double-Blind, Comparative Trial of the Safety and Efficacy of Famotidine vs Placebo for the Treatment of Non-Hospitalized Symptomatic Adults With COVID-19

The overall objective of this study is to evaluate the clinical efficacy of oral famotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This study is expected to enroll up to 84 patients with mild to moderate symptoms divided into each of the two study arms. Clinical outcomes of the two treatment arms will be compared. This study will be conducted virtually/remotely.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The outbreak of coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was first reported in Wuhan, China, in 31 December 2019 and was declared as a global health emergency on 30 January 2020. Currently, there are no definitive vaccine, therapeutic antibody, or antiviral drug countermeasures currently authorized by the FDA for prevention or treatment of mild to moderate COVID-19 disease.

Famotidine is a histamine-2 receptor antagonist, widely available over-the-counter and at low cost, does not interact with other medications and is safely used for suppression of gastric acid production. This makes it a candidate medication for an ambulatory setting to alleviate the symptoms and shorten the symptomatic period in this population. In a case series of 10 patients with COVID-19 who self-medicated with oral famotidine, significant improvement of symptoms was associated with famotidine use after 24-48 hours. These effects were noted in patients who mostly took doses of 80mg three times daily suggesting that famotidine's action is either through its main known high affinity target, the histamine type 2 receptor or through combined inhibition of histamine receptors. Famotidine may work through reduction of H2R signaling on monocytes with a resulting reduction of cytokine release.

The working hypothesis is that famotidine will be superior to placebo in reducing disease related symptoms in non-hospitalized COVID-19 patients with mild or moderate disease. Patients will be monitored for the duration of the study, as well as be asked to record the severity of their symptoms through a daily questionnaire. Current standard of care (SOC) for patients with mild to moderate COVID-19 in the outpatient setting is to assess risk for severe disease and determine the need for an in-person visit, thromboprophylaxis and adjustment of home medication regimen. If the SOC for COVID-19 patients in the outpatient setting changes during the course of the study, a request will be submitted to modify sections of the protocol.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Adult ≥18 years of age at time of enrollment.
  4. Subject consents to randomization.
  5. Subject has confirmed COVID-19 disease < 72 hours prior to randomization.
  6. Subject has been experiencing symptoms for >1 day but ≤7 days.
  7. Able to use an electronic tablet and Bluetooth devices.

  8. Subject has mild to moderate COVID-19 which is defined as (equivalent to 1, 2 on the WHO scale):

    1. Patient does not require immediate admission to the hospital within 24 hrs of initial assessment
    2. Patient does not require supplemental oxygen due to COVID-19
    3. Patient has a score of 2 ("moderate") in at least 3 of the symptoms in the COVID- 19 symptom score

Exclusion Criteria:

  1. Any exposure to investigational medications targeting COVID-19 during the present disease. These include recently approves antibodies (passive immunization) for treatment of COVID-19.
  2. Use of famotidine within the last 30 days for any indication, e.g. medicating gastric ulcer or recent off label use for COVID-19.
  3. Severe COVID-19 disease at time of enrollment requiring admission to hospital.
  4. History of Stage 3 severe chronic kidney disease, i.e. eGFR of < 60ml/min.
  5. Allergy to famotidine or non-medical ingredients of the study tablet.
  6. Known to be immunocompromised by treatment for existing disease due to the immunomodulatory effects of famotidine and therefore possible effects on the pre- existing disease or the immunosuppressive therapy.
  7. Patients currently using tizanidine.
  8. Documented deficiency of any of the following minerals: Al, Cu, Mn, Fe and Zn.
  9. Inability to perform the tasks required for the patient reported outcome measure recordings, including but not restricted to limited language proficiency.
  10. Have symptoms of dysphagia or inability to swallow size #000 capsules.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Famotidine
Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.
Drug: Famotidine
Standard or care treatment plus prescribed famotidine
Placebo Comparator: Placebo
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Drug: Placebo
Standard of care treatment plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of symptom resolution
Time Frame: Day 28
Measured by the cumulative incidence of symptom resolution using the "COVID-19 Symptom Score" derived from the answers to a questionnaire based on the NIH endorsed guidelines and the recent FDA guidelines for studying COVID-19 in an outpatient setting. A shorter version has been utilized as a scoring system in the case series of famotidine use in non-hospitalized patients with COVID-19.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of symptom resolution
Time Frame: Day 28
Assessed by modelling the resolution of cumulative symptoms over time
Day 28
Cumulative incidence of symptom resolution
Time Frame: Day 60
Assessed using the "COVID-19 Symptom Score"
Day 60
Relative change of symptoms
Time Frame: Day 7
Assessed using the "COVID-19 Symptom Score"
Day 7
Assessment of Serious Adverse Events
Time Frame: Day 60
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Day 60
Clinical improvement
Time Frame: Day 28
Assessed using the 9-point ordinal scale recommended by the WHO for trials enrolling patients with COVID-19.
Day 28
Improvement in peripheral oxygen saturation
Time Frame: Day 7
Measured by pulse oximetry in % oxygen saturation.
Day 7
Mortality
Time Frame: Day 28
Assessed by counting mortality in each arm
Day 28
Comparative proportions of hospitalized patients
Time Frame: Day 0-28
Measured by the proportions of patients having been hospitalized by Day 28.
Day 0-28
Change in CRP
Time Frame: Day 7, 14, and 28.
Measured by CRP [mg/L]
Day 7, 14, and 28.
Change in procalcitonin
Time Frame: Day 7, 14, and 28.
procalcitonin [microg/L]
Day 7, 14, and 28.
Change in ferritin
Time Frame: Day 7, 14, and 28.
ferritin [microg/L]
Day 7, 14, and 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

Cold Spring Harbor Laboratory

Investigators

  • Principal Investigator: Tobias Janowitz, MD, PhD, Cold Spring Harbor Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

May 3, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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