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

• Sponsor: Chattogram General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04504240
• Collaborator: M Abdur Rahim Medical College and Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other)
• Enrollment: 208
• Locations: 2
• Arms: 2
• Actual Duration (Months): 8.4
• Patients Per Site: 104
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Famotidine 20 MG	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
• Actual Study Start Date: Aug 1, 2020
• Actual Primary Completion Date: Apr 15, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to Clinical Improvement (TTCI) [Following randomization 30days.]

   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.

2. Time to symptomatic recovery. [Following randomization 30 days.]

   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.

Secondary Outcome Measures

1. Mortality Rate [Following randomization 30 days.]

   Mortality Rate in percentage in study groups.

2. Duration of ICU Stay. [Following randomization 30 days.]

   Duration of ICU Stay in days.

3. Total hospital stay. [Following randomization 30 days.]

   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).

4. Time to clinical failure or death. [Following randomization 30 days.]

   Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first).

5. Time to Viral clearance / COVID-19 recovery. [Following randomization 60 days.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chattogram General Hospital	Chittagong		Bangladesh	4000
2	M. Abdur Rahim Medical College Hospital	Dinājpur		Bangladesh

Sponsors and Collaborators

• Chattogram General Hospital
• M Abdur Rahim Medical College and Hospital
• First Affiliated Hospital Xi'an Jiaotong University

Investigators

• Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abu Taiub Mohammed Mohiuddin Chowdhury, Doctoral Resident, First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT04504240
• Other Study ID Numbers: 10000753/980
• First Posted: Aug 7, 2020
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abu Taiub Mohammed Mohiuddin Chowdhury, Doctoral Resident, First Affiliated Hospital Xi'an Jiaotong University: COVID 19; Famotidine; Bangladesh
• Additional relevant MeSH terms: COVID-19; Famotidine

Study Results

No Results Posted as of Oct 26, 2021