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

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ClinicalTrials.gov Identifier: NCT04504240
Recruitment Status : Completed
First Posted : August 7, 2020
Last Update Posted : October 26, 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

Tracking Information
First Submitted Date  ICMJE August 6, 2020
First Posted Date  ICMJE August 7, 2020
Last Update Posted Date October 26, 2021
Actual Study Start Date  ICMJE August 1, 2020
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Symptomatic improvement [ Time Frame: Following randomization 10 days. ]
    The number of participants with "Symptomatic improvement" determined by the improvement of individual presenting symptoms of the COVID-19 disease. Major symptoms, fever, cough, respiratory distress, chest tightness, sore throat, and myalgia will be rerecorded daily. This will be done by the investigators in the case of the hospitalized patients and the patient itself by a daily self assessment cart in the case of OPD patients.
  • "Clinical status (Stable or Deteriorate clinical state)" [ Time Frame: Following randomization 15 days. ]
    The number of participants with "Clinical status (Stable or Deteriorate clinical state)" determined by the chart or the judgment of the investigators. This will be defined as OPD patients require hospitalization, Hospitalized patients require High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
  • Mortality Rate [ Time Frame: Following randomization 30 days. ]
    Mortality Rate in percentage in study groups.
  • Duration of ICU Stay. [ Time Frame: Following randomization 30 days. ]
    Duration of ICU Stay in days.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
Adverse effects [ Time Frame: Following randomization 15 days. ]
The number of participants with "adverse effects" determined by the existence of the pharmacological side effects of the particular drug (Famotidine) during treatment. The adverse effect will define as the symptoms expressed by the participants following the starting of the treatment other than the disease symptoms, those are within the proven/enlisted pharmacological side effects of the particular drug therapy. Adverse effects will be evaluated by the investigators during follow-ups or communication on phone or during the final collection of the recovery chart.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Famotidine in the Clinical Improvement of COVID-19 Patients.
Official Title  ICMJE Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE Drug: Famotidine 20 MG
Famotidine; tablet Famotac 20mg oral form.
Other Name: Famotac 20mg
Study Arms  ICMJE
  • Experimental: Group A: FAMOTIDINE treatment group
    FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.
    Intervention: Drug: Famotidine 20 MG
  • Active Comparator: Group B: Control group
    Treatment as given with a PPI.
    Intervention: Drug: Famotidine 20 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2021)
208
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
200
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04504240
Other Study ID Numbers  ICMJE 10000753/980
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor  ICMJE Chattogram General Hospital
Collaborators  ICMJE
  • M Abdur Rahim Medical College and Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
Investigators  ICMJE
Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD First Affiliated Hospital Xi'an Jiaotong University
PRS Account Chattogram General Hospital
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP