Clinical trial of Favipiravir treatment of patients with COVID-19

Phase 1

• Conditions: Patients with new type of coronavirus (SARS-CoV-2) infection proven by RT-PCR test with mild pneumonia.; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002728-35-HU
• Lead Sponsor: Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-13
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

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.
11)Male patients who are unable to consent to the use of the barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm from the start up until 90 days after the end of favipiravir administration.
12)Female patients who intend to breastfeed from the start of favipiravir administration until 7 days after discontinuation of favipiravir administration
13)Patients with hereditary xanthinuria
14)Patients who have previously been diagnosed with hyperuricemia (> 1 mg/dL) or xanthine urinary calculi
15)Patients with a history of gout or on treatment for gout or hyperuricemia
16)Patients receiving immunosuppressants
17)Patients who have received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 9 days after fever onset (37.5°C or more)
18)Patients in whom this episode of infection is a recurrence or a reinfection with the SARS-CoV-2 infection
19)Patients who have previously received favipiravir (T-705a)
20)Other patients judged ineligible by the investigator, sub-investigator, or assigned physician

Study & Design

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