COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04724720

Tobias Janowitz, MD, PhD

janowitz@cshl.edu

2021-01-26

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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

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.

2

Northwell Health

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

56

Cumulative incidence of symptom resolution

None

Phase 2

[{"arm_notes": "", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]