Famotidine for mild-to-moderate COVID-19 succeeds in phase II trial

Use of famotidine in the treatment of outpatients with mild-to-moderate COVID-19 is safe and well tolerated, leading to rapid resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity, according to the results of a phase II trial.

A total of 55 adult patients (median age 35 years, 64 percent female, 33 percent African American) were randomized to receive 80-mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Treatment was self-administered.

There were no significant between-group differences in baseline total symptom scores (median 18 for both) and average symptom durations (median 4 days for both). Physiological measurements were in the normal range for most patients, including average oxygen saturation at 99 percent.

Time to resolution of symptoms was the primary endpoint, rate of symptom resolution was secondary, and resolution of inflammation was exploratory.

Fifty-two patients (95 percent) completed the trial, contributing 1,358 electronic symptom surveys. There was no significant improvement in time to symptom resolution with either treatment group (p=0.4), whereas the rate of symptom resolution was higher among patients taking famotidine (p<0.0001).

Overall baseline symptom scores were halved by 8.2 days (95 percent confidence interval [CI], 7–9.8) with famotidine vs 11.4 days (95 percent CI, 10.3–12.6) with placebo. The differences were independent of sex, race, or ethnicity.

Self-limiting adverse events occurred in two patients on famotidine and three on placebo (40 percent and 60 percent, respectively). At day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were comparable between the two treatment groups.