Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19 (NCT04724720) | Clinical Trial Compass
CompletedPhase 2
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
United States56 participantsStarted 2021-01-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested famotidine — which is basically a common heartburn medication — against a placebo for COVID-19 in people who weren't hospitalized; is that something worth discussing as an option for my situation, or is it too far outside standard care?
2Since this was a Phase 2 trial, what does that mean for how confident we can be about whether famotidine actually helped with symptom resolution, and are there larger studies that followed up on these results?
3The trial focused on symptom resolution as its main goal — do you know yet whether the results showed famotidine made a meaningful difference compared to the placebo group?
4Given that this study is now completed, has the data been published anywhere, and would the findings change how you'd approach my treatment compared to current standard COVID-19 options?
5Famotidine is already widely available and used for other conditions — if the results looked promising, would there be any reason not to discuss trying it, or are there interactions with my current medications I should be aware of?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject has mild to moderate COVID-19 which is defined as (equivalent to 1, 2 on the WHO scale):
Exclusion criteria
. 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.