COVID-19 PandemicNCT05122208
Famotidine in Covid-19 Intensive Care Unit
An observational study of COVID-19 Pandemic, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a pandemic with high mortality and morbidity. Since a fully proven treatment has not been developed, the efficacy of currently available treatments is being investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Famotidine Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 15 Aug 2021
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients followed in the Covid-19 Intensive Care Units
Who may be able to join
- Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR
Who cannot join
- immunosuppression
- end-stage renal disease
- liver disease
- G6PD deficiency
- long QT syndrome in ECG
- psoriasis
Show all 9Show fewer
- porphyria
- pregnant
- allergic reactions to famotidine or similar drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients
The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a pandemic with high mortality and morbidity. Since a fully proven treatment has not been developed, the efficacy of currently available treatments is being investigated. Famotidine, an H2Receptor blocker, is one of the drug treatments being investigated. In this study, we aimed to investigate the effect of Famotidine treatment on the clinic and mortality of Covid-19 patients treated in the intensive care unit.
Read the detailed description
The computer and written records of the patients followed in the Covid-19 Intensive Care Units of a research hospital during the pandemic process will be examined. Patients over the age of 18 who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR (Polymeraze Chaine Reaction) will be included in the study. Patients with immunosuppression, end-stage renal disease, liver disease, G6PD deficiency, ALT/AST >5, long QT syndrome in ECG, diagnosed with psoriasis, porphyria, pregnant, and allergic reactions to famotidine or similar drugs were excluded from the study. Patients' age, gender, comorbidities, smoking and APACHE II score will be recorded. Patients who were administered Famotidine 160 mg/day PO or nasogastric and were not given this treatment since their admission to the intensive care unit will be compared. The primary outcome will be the need for invasive mechanical ventilation, intensive care mortality, and both. As a secondary outcome, serum markers indicating the severity of the disease (Leukocytes, lymphocytes, neutrophils/leukocytes, platelets, ferritin, CRP, D-Dimer, fibrinogen, procalcitonin, IL-6, troponin, creatinine, AST, ALT, P/F ratio and lactate) will be recorded.
- Conditions
- COVID-19 Pandemic
- Being tested
- Famotidine Tablets
- Keywords
- COVID-19 Intensive Care Unit, Famotidine, mortality, entubation
- 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 TabletsDrug
160 mg/day Famotidine
| Study group | Role | What they receive |
|---|---|---|
| Famotidine Group | Patients who were administered Famotidine 160 mg/day PO or nasogastric. Receives: Drug: Famotidine Tablets | |
| Control Group | Patients who were not administered Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who died in intensive care
Mortality in intensive care
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Number of patients who were intubated in intensive care
Development of respiratory distress requiring intubation in the patient
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Secondary outcomes (5)
Ferritin
Ferritin in nonogram/miiliter
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
CRP
C-Reactive protein in miligram/liter
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
D-Dimer
D-Dimer in nonogram/miiliter
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Fibrinogen
Fibrinogen in nonogram/miiliter
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Procalcitonin
Procalcitonin in nonogram/miiliter
Measured: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Mar 2020
- Primary completion30 Mar 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mesure gul nihan ozden, Istanbul Medeniyet University
- Investigators
- mesure Gul Nihan Ozden, MD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122208
- Sponsor's protocol ID
- istanbulMU intensive care
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients
- ClinicalTrials.gov ID
- NCT05122208
- Acronym / sponsor ID
- istanbulMU intensive care
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19 Intensive Care Unit, Famotidine, mortality, entubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 16 Nov 2021 (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.
The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a pandemic with high mortality and morbidity. Since a fully proven treatment has not been developed, the efficacy of currently available treatments is being investigated. Famotidine, an H2Receptor blocker, is one of the drug treatments being investigated. In this study, we aimed to investigate the effect of Famotidine treatment on the clinic and mortality of Covid-19 patients treated in the intensive care unit.
Detailed description
The computer and written records of the patients followed in the Covid-19 Intensive Care Units of a research hospital during the pandemic process will be examined. Patients over the age of 18 who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR (Polymeraze Chaine Reaction) will be included in the study. Patients with immunosuppression, end-stage renal disease, liver disease, G6PD deficiency, ALT/AST >5, long QT syndrome in ECG, diagnosed with psoriasis, porphyria, pregnant, and allergic reactions to famotidine or similar drugs were excluded from the study. Patients' age, gender, comorbidities, smoking and APACHE II score will be recorded. Patients who were administered Famotidine 160 mg/day PO or nasogastric and were not given this treatment since their admission to the intensive care unit will be compared. The primary outcome will be the need for invasive mechanical ventilation, intensive care mortality, and both. As a secondary outcome, serum markers indicating the severity of the disease (Leukocytes, lymphocytes, neutrophils/leukocytes, platelets, ferritin, CRP, D-Dimer, fibrinogen, procalcitonin, IL-6, troponin, creatinine, AST, ALT, P/F ratio and lactate) will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Famotidine Group | – | Drug: Famotidine TabletsPatients who were administered Famotidine 160 mg/day PO or nasogastric. |
| Control Group | – | –Patients who were not administered Famotidine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients followed in the Covid-19 Intensive Care Units
Key inclusion criteria (1 listed)
- Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR
Key exclusion criteria (9 listed)
- immunosuppression
- end-stage renal disease
- liver disease
- G6PD deficiency
- long QT syndrome in ECG
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 Tablets160 mg/day Famotidine | Drug | Famotidine Group |
Primary outcome
Number of patients who died in intensive care
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Mortality in intensive care
Number of patients who were intubated in intensive care
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Development of respiratory distress requiring intubation in the patient
5 secondary outcomes
Ferritin
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
CRP
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
D-Dimer
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Fibrinogen
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Procalcitonin
Time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
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 19 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
mesure Gul Nihan Ozden, MD principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 inclusion and 9 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
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?
Number of patients who died in intensive care (time frame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date). 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 19 Apr 2022.