Status:
ACTIVE_NOT_RECRUITING
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Cold Spring Harbor Laboratory
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
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 dec...
Eligibility Criteria
Inclusion
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Adult ≥18 years of age at time of enrollment.
- Subject consents to randomization.
- Subject has confirmed COVID-19 disease \< 72 hours prior to randomization.
- Subject has been experiencing symptoms for \>1 day but ≤7 days.
- Able to use an electronic tablet and Bluetooth devices.
- Subject has mild to moderate COVID-19 which is defined as (equivalent to 1, 2 on the WHO scale):
- Patient does not require immediate admission to the hospital within 24 hrs of initial assessment
- Patient does not require supplemental oxygen due to COVID-19
- Patient has a score of 2 ("moderate") in at least 3 of the symptoms in the COVID- 19 symptom score
Exclusion
- Any exposure to investigational medications targeting COVID-19 during the present disease. These include recently approves antibodies (passive immunization) for treatment of COVID-19.
- Use of famotidine within the last 30 days for any indication, e.g. medicating gastric ulcer or recent off label use for COVID-19.
- Severe COVID-19 disease at time of enrollment requiring admission to hospital.
- History of Stage 3 severe chronic kidney disease, i.e. eGFR of \< 60ml/min.
- Allergy to famotidine or non-medical ingredients of the study tablet.
- 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.
- Patients currently using tizanidine.
- Documented deficiency of any of the following minerals: Al, Cu, Mn, Fe and Zn.
- Inability to perform the tasks required for the patient reported outcome measure recordings, including but not restricted to limited language proficiency.
- Have symptoms of dysphagia or inability to swallow size #000 capsules.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04724720
Start Date
January 19 2021
End Date
June 1 2022
Last Update
April 12 2022
Active Locations (1)
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1
Northwell Health
Lake Success, New York, United States, 11042