Famotidine in Covid-19 Intensive Care Unit

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Drug: Famotidine Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Famotidine Group<br>Patients who were administered Famotidine 160 mg/day PO or nasogastric. | Drug: Famotidine Tablets<br>* 160 mg/day Famotidine<br>|
| Control Group<br>Patients who were not administered Famotidine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who died in intensive care | Mortality 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 | 
| Number of patients who were intubated in intensive care | Development of respiratory distress requiring intubation in the patient | Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin | Ferritin in nonogram/miiliter | 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 | 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 | 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 | 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 | Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Intensive Care Unit, Famotidine, mortality, entubation