Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit

Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience

Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience

Study Overview

• Status: Completed
• Conditions: Mortality; Intensive Care Unit

Detailed Description

Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34771
    • SisliHamidiye Etfal Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study

Description

Inclusion Criteria:

• 18 Years and older

Exclusion Criteria:

• patients younger than 18 years old
• patients who have received both lopinavir-ritonavir and favipiravir sepuentially

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Favipiravir therapy; Favipiravir was advised to all patients with severe pneumonia and progressing pneumonia findings or worsening clinical manifestations except pregnant, breast feeding, postpartum woman. PCR results were not waited to start favipiravir in this group of patients and continued if it would be negative but tomography findings were consistent with COVID-19. Loading dose was 1600 mg twice a day. Maintenance dose was 600 mg per 12 hours for four days.
Lopinavir-ritonavir therapy; Lopinavir-ritonavir therapy was used in selected ICU patients before widespread availability of favipiravir (23 March 2020) and/or if favipiravir was contraindicated. Combination of lopinavir 200 mg-ritonavir 50 mg tablet was the given form. It was given as double tablets twice daily for 10-14 days. Patients were accepted as under favipiravir therapy if they had incomplete course of lopinavir-ritonavir therapy (less than 5 days) and followed by favipiravir for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality for ICU	If the patient dies, we have reached an outcome	14 days
hospital stay	If the hospital stay exceeds 14 days, we have reached an outcome	14 days

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: sultan acar sevinc, Sisli Hamidiye Etfal Education and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: November 7, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: covid 19; favipiravir
• 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
• Other Study ID Numbers: 2854

Drug and device information, study documents

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