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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504240
Recruitment Status : Active, not recruiting
First Posted : August 7, 2020
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
M Abdur Rahim Medical College and Hospital
First Affiliated Hospital Xi'an Jiaotong University
Information provided by (Responsible Party):
Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : August 1, 2020
Estimated Primary Completion Date : April 10, 2021
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Famotac 20mg




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504240


Locations
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Bangladesh
Chattogram General Hospital
Chittagong, Bangladesh, 4000
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
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Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD First Affiliated Hospital Xi'an Jiaotong University
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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: August 7, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, First Affiliated Hospital Xi'an Jiaotong University:
COVID 19
Famotidine
Bangladesh
Additional relevant MeSH terms:
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Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs