COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005214-18/LT

Vilnius University Hospital Santaros klinikos - National coordinator

greta.burneikaite@santa.lt

2020-11-04

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(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 without new lung lesions on chest images that are compatible with pneumonia 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

(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 (for example 1-3-β glucan: 30 pg/ml or higher) (5) Patients who show, for example, 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. (11) Male patients whose partner cannot agree to use the contraception method described in (10) above (12) Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration (13) Female patients who intend to breastfeed from start of favipiravir administration until 14 days after discontinuation of favipiravir administration (14) Patients with hereditary xanthinuria (15) Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi (16) Patients with a history of gout or on treatment for gout or hyperuricemia (17) Patients receiving immunosuppressants (18) 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 (37.5°C or more). (19) Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection (20) Patients who have previously received favipiravir (T-705a) (21) Other patients judged ineligible by the investigator, sub-investigator, or assigned physician

2

Vilnius University Hospital Santaros klinikos

18

74

Lithuania

Mild disease at enrollment

1: Mild disease at enrollment

75

The primary endpoint is the time from initiation of the study drug to the time of “improvement” in body temperature, SpO2, and chest imaging and negative SARS-CoV-2.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]