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

Vilnius University Hospital Santaros klinikos0 sites96 target enrollmentNovember 4, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 4, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Vilnius University Hospital Santaros klinikos

•(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 enrollment
•3\.1\)Patients with SARS\-CoV\-2\-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT\-PCR test
•3\.2\)Patients with new lung lesions on chest images
•3\.3\)Patients 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 and are suspected to have concurrent bacterial infection
•(4\)Patients with suspected concomitant fungal infections prior to initiation of study drug 1\-3\-ß glucan (for example, 30 pg/ml or higher)
•(5\)Patients who, for example, show abnormal NT\-pro BNP levels (100 pg/mL or higher) and are suspected to have concurrent congestive heart failure
•(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 unable to consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 14 days after the end of favipiravir administration