Role of Famotidine in the Clinical Improvement of COVID-1... | NCT04504240

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

NCT04504240

Sponsor

Chattogram General Hospital

Status

Completed

Last Update Posted

Oct 26, 2021Actual

Enrollment

208Actual

Phase

Phase 3

Conditions

Covid19

Interventions

Famotidine 20 MG

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Apr 15, 2021Actual

Completion Date

Apr 15, 2021Actual

First Submitted Date

Aug 6, 2020

First Submission Date that Met QC Criteria

Aug 6, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2021

Last Update Posted Date

Oct 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abu Taiub Mohammed Mohiuddin Chowdhury, Doctoral Resident, First Affiliated Hospital Xi'an Jiaotong UniversityPrincipal Investigator

Lead Sponsor

Chattogram General HospitalOTHER_GOV

Collaborators

Name	Class
M Abdur Rahim Medical College and Hospital	OTHER_GOV
First Affiliated Hospital Xi'an Jiaotong University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: FAMOTIDINE treatment group	Experimental	FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.	Drug: Famotidine 20 MG
Group B: Control group	Active Comparator	Treatment as given with a PPI.	Drug: Famotidine 20 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Famotidine 20 MG	Drug	Famotidine; tablet Famotac 20mg oral form.	Group A: FAMOTIDINE treatment group Group B: Control group

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD	First Affiliated Hospital Xi'an Jiaotong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chattogram General Hospital		Chittagong		4000	Bangladesh
M. Abdur Rahim Medical College Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015738	Famotidine

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided