Famotidine in Covid-19 Intensive Care Unit
- Registration Number
- NCT05122208
- Lead Sponsor
- Istanbul Medeniyet University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR
- immunosuppression
- end-stage renal disease
- liver disease
- G6PD deficiency
- long QT syndrome in ECG
- psoriasis
- porphyria
- pregnant
- allergic reactions to famotidine or similar drugs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Famotidine Group Famotidine Tablets Patients who were administered Famotidine 160 mg/day PO or nasogastric.
- Primary Outcome Measures
Name Time Method Number of patients who died in intensive care 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 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
- Secondary Outcome Measures
Name Time Method CRP Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date C-Reactive protein in miligram/liter
D-Dimer 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 in nonogram/miiliter
Fibrinogen Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date Fibrinogen in nonogram/miiliter
Procalcitonin Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date Procalcitonin in nonogram/miiliter
Ferritin Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date Ferritin in nonogram/miiliter
Trial Locations
- Locations (1)
Istanbul Medeniyet University
🇹🇷İ̇stanbul, Turkey