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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

Bangladesh

Study Type

Interventional

Intervention

Famotidine 20 MG

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID 19, Famotidine, Bangladesh

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chattogram General Hospital
M. Abdur Rahim Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: FAMOTIDINE treatment group

Group B: Control group

Arm Description

FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.

Treatment as given with a PPI.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Mortality Rate

Mortality Rate in percentage in study groups.

Duration of ICU Stay.

Duration of ICU Stay in 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).

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).

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.

Full Information

NCT ID

NCT04504240

First Posted

August 6, 2020

Last Updated

October 23, 2021

Sponsor

Chattogram General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04504240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

April 15, 2021 (Actual)

Study Completion Date

April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chattogram General Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID 19, Famotidine, Bangladesh

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: FAMOTIDINE treatment group

Arm Type

Experimental

Arm Description

FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.

Arm Title

Group B: Control group

Arm Type

Active Comparator

Arm Description

Treatment as given with a PPI.

Intervention Type

Drug

Intervention Name(s)

Famotidine 20 MG

Other Intervention Name(s)

Famotac 20mg

Intervention Description

Famotidine; tablet Famotac 20mg oral form.

Primary Outcome Measure Information:

Title

Time to Clinical Improvement (TTCI)

Description

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 Frame

Following randomization 30days.

Title

Time to symptomatic recovery.

Description

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.

Time Frame

Following randomization 30 days.

Secondary Outcome Measure Information:

Title

Mortality Rate

Description

Mortality Rate in percentage in study groups.

Time Frame

Following randomization 30 days.

Title

Duration of ICU Stay.

Description

Duration of ICU Stay in days.

Time Frame

Following randomization 30 days.

Title

Total hospital stay.

Description

Time Frame

Following randomization 30 days.

Title

Time to clinical failure or death.

Description

Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first).

Time Frame

Following randomization 30 days.

Title

Time to Viral clearance / COVID-19 recovery.

Description

Time Frame

Following randomization 60 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Study Chair

Facility Information:

Facility Name

Chattogram General Hospital

City

Chittagong

ZIP/Postal Code

4000

Country

Bangladesh

Facility Name

M. Abdur Rahim Medical College Hospital

City

Dinājpur

Country

Bangladesh

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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