Covid19Phase 3NCT04504240
Role of Famotidine in the Clinical Improvement of COVID-19 Patients.
A Phase 3 study testing Famotidine 20 MG in people with Covid19, run by Chattogram General Hospital at 2 sites in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Famotidine 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesBangladesh
- Study dates
- 1 Aug 2020to 15 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
- Severe COVID-19 patients require hospitalization under HDU/ICU.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Chattogram General Hospital
Chittagong, 4000
M. Abdur Rahim Medical College Hospital
Dinājpur
About this study
Official title: Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
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.
- Conditions
- Covid19
- Being tested
- Famotidine 20 MG
- Keywords
- COVID 19, Famotidine, Bangladesh
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famotidine 20 MGDrug
Also called Famotac 20mg
Famotidine; tablet Famotac 20mg oral form.
| Study group | Role | What they receive |
|---|---|---|
| Group A: FAMOTIDINE treatment group | Experimental | FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments. Receives: Drug: Famotidine 20 MG |
| Group B: Control group | Active comparator | Treatment as given with a PPI. Receives: Drug: Famotidine 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Following randomization 30 days.
Secondary outcomes (5)
Mortality Rate
Mortality Rate in percentage in study groups.
Measured: Following randomization 30 days.
Duration of ICU Stay.
Duration of ICU Stay in days.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Following randomization 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Aug 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattogram General Hospital
- Sponsor type
- Other government
- Collaborators
- M Abdur Rahim Medical College and Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504240
- Sponsor's protocol ID
- 10000753/980
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.
- ClinicalTrials.gov ID
- NCT04504240
- Acronym / sponsor ID
- 10000753/980
- Conditions
- Covid19
- Keywords
- COVID 19, Famotidine, Bangladesh
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Chattogram General HospitalOther government
- Collaborators
- M Abdur Rahim Medical College and Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: FAMOTIDINE treatment group | Experimental | Drug: Famotidine 20 MGFAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments. |
| Group B: Control group | Active comparator | Drug: Famotidine 20 MGTreatment as given with a PPI. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- SARS-CoV-2 infection confirmed by RT PCR or CT Chest.
- Severe COVID-19 patients require hospitalization under HDU/ICU.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Famotidine 20 MGAlso: Famotac 20mgFamotidine; tablet Famotac 20mg oral form. | Drug | Group A: FAMOTIDINE treatment group, Group B: Control group |
Primary outcome
Time to Clinical Improvement (TTCI)
Time frame: Following randomization 30days.
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 frame: Following randomization 30 days.
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.
5 secondary outcomes
Mortality Rate
Time frame: Following randomization 30 days.
Duration of ICU Stay.
Time frame: Following randomization 30 days.
Total hospital stay.
Time frame: Following randomization 30 days.
Time to clinical failure or death.
Time frame: Following randomization 30 days.
Time to Viral clearance / COVID-19 recovery.
Time frame: Following randomization 60 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD study chair
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Famotidine 20 MG in people with Covid19, run by Chattogram General Hospital at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Improvement (TTCI) (time frame: Following randomization 30days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.