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

NCT04504240 | Completed Phase 3 DMC

• 1 other identifier: 10000753/980
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

COVID 19; Famotidine; Bangladesh

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mortality Rate

  Following randomization 30 days.

• Duration of ICU Stay.

  Following randomization 30 days.

• Total hospital stay.

  Following randomization 30 days.

• Time to clinical failure or death.

  Following randomization 30 days.

• Time to Viral clearance / COVID-19 recovery.

  Following randomization 60 days.

Study Arms (2)

Group A: FAMOTIDINE treatment group

EXPERIMENTAL

FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.

Drug: Famotidine 20 MG

Group B: Control group

ACTIVE COMPARATOR

Treatment as given with a PPI.

Drug: Famotidine 20 MG

Interventions

Famotidine 20 MG DRUG

Famotidine; tablet Famotac 20mg oral form.

Also known as: Famotac 20mg

Group A: FAMOTIDINE treatment group; Group B: Control group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Chattogram General Hospital

Chittagong, 4000, Bangladesh

Location

M. Abdur Rahim Medical College Hospital

Dinājpur, Bangladesh

Location

MeSH Terms

Conditions

COVID-19

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Resident

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)