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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
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
Processing time: 149 Days and 4.8 Hours
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 H2 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.
Core Tip: Treatment with famotidine demonstrated a comparatively better outcome in the survival rates of patients. A rapid recovery time, less duration of intensive care unit (ICU) stay among the survivors, favorable improvement in the computed tomography findings and an earlier viral clearance were observed in the famotidine treatment group which differ significantly in a t-test (P ≤ 0.05). The difference between the time to symptomatic recovery, ICU stay duration and the national early warning score-2 on discharge was not significant however, mean values were relatively less than the control. Nevertheless, survival benefit was not significant with the famotidine as an added treatment for severe coronavirus disease 2019.
