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

Phase 3

Completed

• Conditions: Covid19
• Interventions: Drug: Famotidine 20 MG

• Registration Number: NCT04504240
• Lead Sponsor: Chattogram General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-23
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: Control group	Famotidine 20 MG	Treatment as given with a PPI.
Group A: FAMOTIDINE treatment group	Famotidine 20 MG	FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
Mortality Rate	Following randomization 30 days.	Mortality Rate in percentage in study groups.
Duration of ICU Stay.	Following randomization 30 days.	Duration of ICU Stay in days.
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).
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).

Trial Locations

Locations (2)

M. Abdur Rahim Medical College Hospital; 🇧🇩 Dinājpur, Bangladesh

Chattogram General Hospital; 🇧🇩 Chittagong, Bangladesh