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

NCT ID: NCT04504240

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-04-15

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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: FAMOTIDINE treatment group

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

Group Type EXPERIMENTAL

Famotidine 20 MG

Intervention Type DRUG

Famotidine; tablet Famotac 20mg oral form.

Group B: Control group

Treatment as given with a PPI.

Group Type ACTIVE_COMPARATOR

Famotidine 20 MG

Intervention Type DRUG

Famotidine; tablet Famotac 20mg oral form.

Interventions

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Famotidine 20 MG

Famotidine; tablet Famotac 20mg oral form.

Intervention Type DRUG

Other Intervention Names

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Famotac 20mg

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M Abdur Rahim Medical College and Hospital

OTHER_GOV

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Chattogram General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Abu Taiub Mohammed Mohiuddin Chowdhury

Doctoral Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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Chattogram General Hospital

Chittagong, , Bangladesh

Site Status

M. Abdur Rahim Medical College Hospital

Dinājpur, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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10000753/980

Identifier Type: -

Identifier Source: org_study_id