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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504240
• Other study ID #: 10000753/980
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: October 2021
• Source: Chattogram General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Famotidine 20 MG
Famotidine; tablet Famotac 20mg oral form.

Locations

Country	Name	City	State
Bangladesh	Chattogram General Hospital	Chittagong
Bangladesh	M. Abdur Rahim Medical College Hospital	Dinajpur

Sponsors (3)

Lead Sponsor	Collaborator
Chattogram General Hospital	First Affiliated Hospital Xi'an Jiaotong University, M Abdur Rahim Medical College and Hospital

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Mortality Rate	Mortality Rate in percentage in study groups.	Following randomization 30 days.
Secondary	Duration of ICU Stay.	Duration of ICU Stay in days.	Following randomization 30 days.
Secondary	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.
Secondary	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.
Secondary	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.