Famotidine in Covid-19 Intensive Care Unit

• Sponsor: Istanbul Medeniyet University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05122208
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 16.9
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pandemic	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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Clinical Effects of Famotidine Use in Intensive Care Covid-19 Patients
• Actual Study Start Date: Mar 20, 2020
• Actual Primary Completion Date: Mar 30, 2021
• Actual Study Completion Date: Aug 15, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. 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

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University	İ̇stanbul		Turkey	34730

Sponsors and Collaborators

• Istanbul Medeniyet University

Investigators

• Principal Investigator: mesure Gul Nihan Ozden, MD, Istanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mesure gul nihan ozden, Principal Investigator, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05122208
• Other Study ID Numbers: istanbulMU intensive care
• First Posted: Nov 16, 2021
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by mesure gul nihan ozden, Principal Investigator, Istanbul Medeniyet University: COVID-19 Intensive Care Unit; Famotidine; mortality; entubation
• Additional relevant MeSH terms: COVID-19; Famotidine

Study Results

No Results Posted as of Apr 19, 2022