Clinical Trials Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 16, 2022; 10(23): 8170-8185
Published online Aug 16, 2022. doi: 10.12998/wjcc.v10.i23.8170
Role of H2 receptor blocker famotidine over the clinical recovery of COVID-19 patients: A randomized controlled trial
Abu Taiub Mohammed Mohiuddin Chowdhury, Aktar Kamal, Md Kafil Uddin Abbas, Md Rezaul Karim, Md Ahsan Ali, Shubhashis Talukder, H M Hamidullah Mehedi, Hamid Hassan, Abul Hossain Shahin, Yarui Li, Shuixiang He
Abu Taiub Mohammed Mohiuddin Chowdhury, Yarui Li, Shuixiang He, Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, China
Abu Taiub Mohammed Mohiuddin Chowdhury, Ministry of Health and Family Welfare (OSD-DGHS), Dhaka 1212, Bangladesh
Aktar Kamal, Critical Care Unit, M Abdur Rahim Medical College Hospital, Dinajpur 5200, Bangladesh
Md Kafil Uddin Abbas, Critical Care Unit, Cox's Bazar 250 Bed District Sadar Hospital, Cox's Bazar 4700, Bangladesh
Md Rezaul Karim, Department of Neurology, University Hospital Limerick, Limerick V94 T9PX, Ireland
Md Ahsan Ali, Department of Histology, Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, China
Shubhashis Talukder, Intensive Care Unit, 250 Bed Chattogram General Hospital, Chittagong 4000, Bangladesh
H M Hamidullah Mehedi, Department of Medicine, 250 Bed Chattogram General Hospital, Chittagong 4000, Bangladesh
Hamid Hassan, Department of Emergency, Chattogram Medical College Hospital, Chittagong 4000, Bangladesh
Abul Hossain Shahin, Department of Cardiology, 250 Bed Chattogram General Hospital, Chittagong 4000, Bangladesh
Author contributions: Mohiuddin Chowdhury ATM created the research concept and performed project management, patient selection, treatment, data collection, statistical analysis, and manuscript writing and editing; Kamal A, Abbas MKU, Hassan H and Talukder S contributed to the patient selection, treatment, follow-up and data collection; Karim MR contributed to the manuscript writing and editing; Ali MA contributed to the statistical analysis; Li YR, Hamidullah Mehedi H M and Hossain M contributed to the data interpretation; and He SX carried out a critical review of the manuscript and research supervision, and ensured the quality of the research.
Institutional review board statement: The study was reviewed and approved by the ERC of 250 Bedded General Hospital Chattogram Institutional Review Board Approval No. 980 (Date 18/07/2020).
Clinical trial registration statement: ClinicalTrials.gov ID: NCT04504240.
Informed consent statement: Informed written consent was obtained from each of the patients after explaining the protocol.
Conflict-of-interest statement: None to declare.
Data sharing statement: Consent was not obtained but the presented data are anonymized and the risk of identification is low, therefore anonymized data could be shared upon request to the first and the corresponding authors.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Shui-Xiang He, PhD, Professor, Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Yanta Road, Xi'an 710061, Shaanxi Province, China. dyyyjxk@mail.xjtu.edu.cn
Received: March 5, 2022
Peer-review started: March 5, 2022
First decision: March 27, 2022
Revised: March 30, 2022
Accepted: July 5, 2022
Article in press: July 5, 2022
Published online: August 16, 2022
ARTICLE HIGHLIGHTS
Research background

Famotidine is a histamine-2 receptor antagonist that suppresses gastric acid production. In vitro, famotidine inhibits human immunodeficiency virus replication. Recently, computational methods were applied to predict structures of proteins encoded by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) genome and identified famotidine as one of the drugs most likely to inhibit the 3-chymotrypsin-like protease which processes proteins essential for viral replication. Famotidine use was associated with a reduced risk of intubation and mortality among the patients hospitalized with coronavirus disease 2019 (COVID-19). Therefore, it is necessary to evaluate the potential use of the existing drugs like famotidine that could be used as options for the medical management of COVID-19 patients.

Research motivation

COVID-19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Thus, clinicians and scientists all over the world are struggling with the treatment of this disease. Besides antiviral drugs, immunosuppressive agents and symptomatic therapy like the H2 receptor blocker famotidine came to the limelight due to its role in reducing the symptoms of COVID-19 patients.

Research objectives

To evaluate the role of H2 receptor blocker “famotidine” in COVID-19 illness.

Research methods

COVID-19 patients admitted in the intensive care unit (ICU) of Chattogram General hospital, M. Abdur Rahim Medical College Hospital, and 250 bed Cox’s Bazar Sadar Hospital Bangladesh from July 20, 2020 and onward were enrolled in this study. Patients were divided into famotidine treatment group “A” (famotidine 40 mg to 60 mg oral formulation at 8 h intervals 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 of the patients.

Research results

(1) The recovery (75% in group A and 70% in group B and death (25% in group A and 30% in group B) were found preferable in group A than that in group B; (2) Superior improvement of the computed tomography (CT) chest findings was observed in the famotidine treatment group; (3) Among the group A survivors, the duration of ICU and hospital stays were low; (4) However, the difference between the time to symptomatic recovery, ICU stay duration and the time to clinical failure/death among the groups were not significant, P ≥ 0.05; (5) Group A achieved a reduction of hospital stay and rapid recovery; (6) Viral recovery was delayed in the control group; and (7) The Kaplan Meier survival analysis was performed. The difference involving survival among the two study groups did not show any statistical significance (P = 0.989).

Research conclusions

The famotidine treatment group demonstrated a comparatively better clinical outcome than the control. A rapid recovery time, less duration of ICU stay among the survivors, favorable improvement in the CT findings and an earlier viral clearance was observed in the famotidine treatment group; and were statistically significant in a t-test with the control. However, survival benefit was not significant with the famotidine treatment for severe COVID-19 disease.

Research perspectives

The results of this study will add up to an important point in treating the SARS-CoV-2 infection during this time of desperate need which will have an overall effect in the long run from every perspective.