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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Famotidine 20 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: FAMOTIDINE treatment group<br>FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments. | Drug: Famotidine 20 MG<br>* Famotidine; tablet Famotac 20mg oral form.<br>* Other names: Famotac 20mg;|
| Active Comparator: Group B: Control group<br>Treatment as given with a PPI. | Drug: Famotidine 20 MG<br>* Famotidine; tablet Famotac 20mg oral form.<br>* Other names: Famotac 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Mortality Rate in percentage in study groups. | Following randomization 30 days. | 
| Duration of ICU Stay. | Duration of ICU Stay in days. | Following randomization 30 days. | 
| Total hospital stay. | 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). | Following randomization 30 days. | 
| Time to clinical failure or death. | Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first). | Following randomization 30 days. | 
| Time to Viral clearance / COVID-19 recovery. | 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. | Following randomization 60 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID 19, Famotidine, Bangladesh