Famotidine in Covid-19 Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Drug: Famotidine Tablets

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey, 34730
    • İstanbul medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients followed in the Covid-19 Intensive Care Units

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Famotidine Group; Patients who were administered Famotidine 160 mg/day PO or nasogastric.	Drug: Famotidine Tablets; 160 mg/day Famotidine
Control Group; Patients who were not administered Famotidine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: mesure Gul Nihan Ozden, MD, İstanbul medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: mortality; Famotidine; COVID-19 Intensive Care Unit; entubation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine
• Other Study ID Numbers: istanbulMU intensive care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No