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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04504240
Enrollment
208
Registered
2020-08-07
Start date
2020-08-01
Completion date
2021-04-15
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID 19, Famotidine, Bangladesh

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.

Interventions

Famotidine; tablet Famotac 20mg oral form.

Sponsors

M Abdur Rahim Medical College and Hospital
CollaboratorOTHER_GOV
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Chattogram General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Duration of ICU Stay.Following randomization 30 days.Duration of ICU Stay in days.
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).
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.
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).
Mortality RateFollowing randomization 30 days.Mortality Rate in percentage in study groups.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026