Famotidine in Covid-19 Intensive Care Unit

NCT05122208 | Completed

• 1 other identifier: istanbulMU intensive care
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

COVID-19 Intensive Care Unit; Famotidine; mortality; entubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Ferritin

  Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

• CRP

  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

  Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

• Fibrinogen

  Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

• Procalcitonin

  Within 17 days from the patient's admission to the intensive care unit or if he dies within this period, to this date

Study Arms (2)

Famotidine Group

Patients who were administered Famotidine 160 mg/day PO or nasogastric.

Drug: Famotidine Tablets

Control Group

Patients who were not administered Famotidine

Interventions

Famotidine Tablets DRUG

160 mg/day Famotidine

Famotidine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients followed in the Covid-19 Intensive Care Units

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34730, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• mesure Gul Nihan Ozden, MD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: March 20, 2020
• Primary Completion: March 30, 2021
• Study Completion: August 15, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

TU (1)