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

NCT04645433 | Completed

• 1 other identifier: 2854
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mortality; Intensive Care Unit

Keywords

covid 19; favipiravir

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Years and older

You may not qualify if:

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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

SisliHamidiye Etfal Education and Training Hospital

Istanbul, 34771, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• sultan acar sevinc

  Sisli Hamidiye Etfal Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 27, 2020
• Study Start: March 15, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

TU (1)