Role of Famotidine in the Clinical Improvement of COVID-19 Patients.

Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.

This study is aimed to investigate the effect of Famotidine in the clinical recovery of COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there is no specific medication against it. Like other countries of the world, Besides antiviral drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail history of each participant with comorbidity will be taken and will be examined carefully. The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study. Critically ill patients who require ventilator support will not be included in this study. The outcome of the Famotidine treatment will be evaluated and compared with a control group.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Famotidine 20 MG

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bangladesh
  • Chittagong, Bangladesh, 4000
    • Chattogram General Hospital
  • Dinājpur, Bangladesh
    • M. Abdur Rahim Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
• Severe COVID-19 patients require hospitalization under HDU/ICU.

Exclusion Criteria:

• Patients with severe and/or uncontrolled medical conditions with significantly compromised organ function.
• Patients who were hospitalized from the before due to other reasons.
• Contraindication / possible drug interaction with Famotidine with existing therapy.
• Immunocompromised patients.
• Pregnancy, Pulmonary Tuberculosis, AIDS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: FAMOTIDINE treatment group; FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.	Drug: Famotidine 20 MG; Famotidine; tablet Famotac 20mg oral form.; Other Names: Famotac 20mg
Active Comparator: Group B: Control group; Treatment as given with a PPI.	Drug: Famotidine 20 MG; Famotidine; tablet Famotac 20mg oral form.; Other Names: Famotac 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Clinical Improvement (TTCI)	Time to clinical improvement (TTCI) was defined as time from randomization to National Early Warning Score 2 (NEWS2) Score of ≤2 maintained for 24 Hours.	Following randomization 30days.
Time to symptomatic recovery.	Time to Symptomatic recovery was defined as the duration (in days) that required for the relief of the COVID-19 symptoms from the day of hospitalization.	Following randomization 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Mortality Rate in percentage in study groups.	Following randomization 30 days.
Duration of ICU Stay.	Duration of ICU Stay in days.	Following randomization 30 days.
Total hospital stay.	Time from randomization to hospital discharge or "Ready for discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient Air or ≤4L supplemental oxygen).	Following randomization 30 days.
Time to clinical failure or death.	Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first).	Following randomization 30 days.
Time to Viral clearance / COVID-19 recovery.	This was defined as the duration (in days) from the first positive PCR to the first negative PCR (Confirmed by a repeat negative PCR after 7days) for SARS-Cov-2 infection following hospital discharge.	Following randomization 60 days.

Collaborators and Investigators

• Sponsor: Chattogram General Hospital
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; M Abdur Rahim Medical College and Hospital
• Investigators: Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: COVID 19; Famotidine; Bangladesh
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine
• Other Study ID Numbers: 10000753/980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No