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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: Cold Spring Harbor Laboratory
• Treatments: Famotidine

Criteria

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.