Clinical trial NCT05122208: Famotidine in Covid-19 Intensive Care Unit
Official title: Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Keywords: COVID-19 Intensive Care Unit
Famotidine
mortality
entubation
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients followed in the Covid-19 Intensive Care Units

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR

Exclusion Criteria:

* immunosuppression
* end-stage renal disease
* liver disease
* G6PD deficiency
* long QT syndrome in ECG
* psoriasis
* porphyria
* pregnant
* allergic reactions to famotidine or similar drugs

Primary outcomes:
measure: Number of patients who died in intensive care
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
measure: Number of patients who were intubated in intensive care
timeFrame: 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:
measure: Ferritin
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
measure: CRP
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
measure: D-Dimer
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
measure: Fibrinogen
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
measure: Procalcitonin
timeFrame: Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: mesure Gul Nihan Ozden, MD
role: PRINCIPAL_INVESTIGATOR
References: