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Completed

NCT Number: NCT04504240

Role of Famotidine in the Clinical 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chattogram General Hospital, Chittagong, Bangladesh

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

famotidine 20 mg

Drug

Famotidine; tablet Famotac 20mg oral form.

Other names: Famotac 20mg

Primary outcomes

  1. Time to Clinical Improvement (TTCI)

    Time frame: 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.

    Time frame: 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 outcomes

  1. Mortality Rate

    Time frame: Following randomization 30 days.

    Mortality Rate in percentage in study groups.

  2. Duration of ICU Stay.

    Time frame: Following randomization 30 days.

    Duration of ICU Stay in days.

  3. Total hospital stay.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chattogram General Hospital

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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