The Efficacy of Famotidine in Improvement of Outcomes in Hospitalized COVID-19 Patients: A Phase III Randomized Clinical Trial

Background & Aims: As the first randomized clinical trial, this study evaluated the effect of Famotidine on the improvement of
outcomes of hospitalized patients with COVID-19.
Materials & Methods: This phase III randomized clinical trial which was designed with two parallel arms, is a placebo-controlled,
single-blind, and concealed allocation study, and recruited 20 patients (10 of them received Famotidine as treatment group and 10
received Placebo as control group). Oral Famotidine 160 mg four times a day was given to the COVID-19 patients until the discharge
day or for a maximum of 14 days. Patients’ temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase
(LDH) level, and complete blood count (CBC) were measured at the baseline (before the intervention) and on day 14 after the
intervention or on discharge day. Length of stay in the hospital and length of stay in the ICU were also measured as secondary outcomes
of the study.
Results: The results showed a significant decrease in LDH (P=0.01), mean WBC (P=0.04) and length of stay (P=0.04) of patients with
COVID-19 in the group treated with Famotidine compared to the control group. There was also a significant increase in oxygen
saturation (P=0.01) in the group treated with Famotidine compared to the control group. Cough improvement was also higher in the
oral Famotidine group compared to the control group (P=0.02).
Conclusion: This was the first clinical trial on the effect of Famotidine on the improvement of hospitalized COVID-19 patients, which
indicated that high-dose Famotidine improves patients’ clinical signs and reduces the severity of the disease and duration of
hospitalization.