Famotidine in Covid-19 Intensive Care Unit

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122208
• Other study ID #: istanbulMU intensive care
• Status: Completed
• Start date: March 20, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: April 2022
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Drug:
• Famotidine Tablets
160 mg/day Famotidine

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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