Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia-A randomized, double blind, placebo- controlled study

Phase 1

• Conditions: Patients diagnosed with COVID-19 by positive PCR for SARS-COV2; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002753-22-ES
• Lead Sponsor: Ferrer Internacional, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-20
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Adult age: from 18 to 85 years included (at the time of informed consent) of both genders
2.Patients with categories 3 to 5 on the ordinal scale
3.Patients who meet all of the following criteria 1), 2), 3), and 4) at the time of enrollment
1)Patients who tested positive for SARS-COV2 on RT-PCR test from respiratory specimen(s)
2)Patients with new lung lesions on chest images (chest x-ray, CT scan, etc.)
3)Patients with SpO2 < 94%
4)Patients who meet at least 2 of the following symptoms/findings:
-Fever of 37.5°C or higher
-Respiratory rate = 24/min
-Cough
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 or by legally authorized representative
6. During the influenza virus season, if the incidence is above the epidemic threshold, patients with a
negative test resul
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Patients who show increased procalcitonin levels (1 ng/ml or higher) before the start of study drug administration and are suspected to have concurrent bacterial infection
2.Patients who show abnormal NT-pro BNP levels (400 pg/mL or higher) and are suspected to have concurrent congestive heart failure
3.Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
4.Patients with renal impairment requiring dialysis
5.Patients with disturbed consciousness such as disturbed orientation (except with a nasogastric tube administration)
6.Pregnant or possibly pregnant patients and lactating or nursing female patients
7.Patients (and their partners) who desire to become pregnant during the study period or who cannot abstain from sex or who will not use contraceptives from the start of favipiravir until 14 days after end of administration
8.Male patients whose partner cannot agree to use the contraception method described above (criterion 7)
9.Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration
10.Patients with hereditary xanthinuria
11.Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi
12.Patients with a history of gout or on treatment for gout or hyperuricemia
13.Patients receiving immunosuppressants (tocilizumab and corticosteroids administration is permitted)
14.Other patients judged ineligible by the principal investigator or sub-investigator
15.Known allergy to any study medication and its excipients
16.Patients on the current treatment or who have been treated during last 7 days with remdesivir

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19;Secondary Objective: The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19;Primary end point(s): Time to clinical improvement measured as improvement for = two categories on a 7-point ordinal scale (Time frame: up to 28 days): <br>1. Not hospitalized, no limitations on activities <br>2. Not hospitalized, limitation on activities; <br>3. Hospitalized, not requiring supplemental oxygen; <br>4. Hospitalized, requiring supplemental oxygen; <br>5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; <br>6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); <br>7. Death.;Timepoint(s) of evaluation of this end point: Time frame: up to 28 days