An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients with Mild Pneumonia- An open-label randomized controlled study

Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium0 sites150 target enrollmentAugust 13, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium
Enrollment: 150
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

August 13, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium

•1\)Age: 18 to 74 years (at the time of informed consent)
•2\)Gender: Male or female
•3\)Patients who meet all of the following criteria 1\), 2\), and 3\) at the time of enrolment
•oPatients with SARS\-CoV\-2\-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT\-PCR test
•oPatients with new lung lesions on chest images
•oPatients with a fever of 37\.5°C or more
•4\)For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug
•5\)Patients who understand the contents of this study and are able to provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\)Fever (37\.5°C) more than 10 days after the onset of fever
•2\)Patients with SpO2 less than 95% without oxygen therapy
•3\)Patients who show increased procalcitonin levels before the start of study drug administration or are suspected to have concurrent bacterial infection
•4\)Patients with suspected concomitant fungal infections prior to initiation of study drug.
•5\)Patients with concurrent congestive heart failure (NYHA III\-IV)
•6\)Patients with severe hepatic impairment equivalent to Grade C on Child\-Pugh classification
•7\)Patients with renal impairment requiring dialysis
•8\)Patients with disturbed consciousness such as disturbed orientation
•9\)Pregnant or possibly pregnant patients
•10\)Female patients who are woman of childbearing potential and unable to consent to the use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone\-based contraceptive; Tubal ligation.