Role of H₂ receptor blocker famotidine over the clinical recovery of COVID-19 patients: A randomized controlled trial

Abstract

BACKGROUND Coronavirus disease 2019 (COVID-19) is a global pandemic putting the population at a high risk of infection-related health hazards, mortality and a potential failure of proper medical therapies. Therefore, it is necessary to evaluate the potential use of the existing drugs that could be used as options for the medical management of COVID-19 patients. AIM To evaluate the role of the H 2 receptor blocker “famotidine” in COVID-19 illness. METHODS This study was done on seriously ill COVID-19 patients admitted to the intensive care unit (ICU) from different institutes in Bangladesh. Patients were divided into famotidine treatment group “A” (famotidine 40 mg to 60 mg oral formulation every 8 h with other treatment as given), and control group “B” (treatment as given). National early warning score (NEWS)-2, and sequential organ failure assessment day-1 score was calculated to evaluate the outcome. Outcomes were evaluated by the time required for clinical improvement, characterized as duration required from enrollment to the achievement of NEWS-2 of ≤ 2 maintained for 24 h; time to symptomatic recovery, defined as the duration in days (from randomization) required for the recovery of the COVID-19 symptoms; mortality rate; duration of ICU and hospital stay; total period of hospitalization; the rate of supplementary oxygen requirement; the computed tomography (CT) chest recovery (%), the time required for the viral clearance and “NEWS-2” on discharge. RESULTS A total of 208 patients were enrolled in this study with 104 patients in each group. The famotidine treatment group had comparatively better recovery of 75% and a low mortality of 25% than the control with a recovery of 70% and a mortality of 30%. Duration of clinical improvement (group A 9.53 d, group B 14.21 d); hospitalization period among the recovered patients (group A 13.04 d, group B 16.31 d), pulmonary improvement in chest CT (group A 21.7%, group B 13.2%), and the time for viral clearance (group A 20.7 d, group B 23.8 d) were found to be statistically significant P ≤ 0.05. However, the Kaplan Meier survival test was not significant among the two study groups, P = 0.989. CONCLUSION According to our study, treatment with famotidine achieved a better clinical outcome compared to the control group in severe COVID-19 illness, although no significant survival benefit was found.

Famotidina en el tratamiento de pacientes hospitalizados con COVID-19. Revisión sistemática y metaanálisis

“…Se evaluó también el tiempo de estancia hospitalaria, en el que Samimagham, Pahwani y Mohiuddin 24,28,35 evidenciaron una reducción significativa en los días de hospitalización para los pacientes tratados con famotidina. No obstante, la calidad y cantidad de los estudios incluidos no nos permite determinar esta asociación como un resultado confiable, siendo necesario la evaluación posterior con estudios con mayor escala y un diseño sólido.…”

“…La gran expectativa sobre este fármaco llevó a los investigadores a realizar ensayos clínicos aleatorizados, entre ellos uno doble ciego que involucra grandes dosis de famotidina intravenosa en comparación con hidroxicloroquina o remdesivir (NCT04370262) 23 , aunque al momento de la búsqueda solo se han reportado los resultados de mortalidad. Otros ensayos clínicos con altas dosis de famotidina también se están realizando en países como Bangladesh (NCT04504240) e Irán 24,25 .…”

Vagus nerve SARS‐CoV‐2 infection and inflammatory reflex dysfunction: Is there a causal relationship?

“…Famotidine is a histamine 2 receptor antagonist used for decades in the clinic to inhibit gastric acid production. Surprisingly, recent clinical observations, and subsequent clinical trials, revealed that famotidine attenuates the clinical course of COVID-19 [67][68][69][70][71][72]. The mechanism of the famotidine inhibition of cytokine storm was revealed to be by pharmacological stimulation of the vagus nerve inflammatory reflex [73].…”