COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20200514001

Rujipas Sirijatuphat

rujipas.sir@mahidol.ac.th

2020-05-14

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

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 1) Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, airway aspirate, or saliva by RT-PCR test 2) Patients without lung lesions on chest images that compatible with pneumonia 3) Patients with a fever more than or equal to 37.5 degree celsius or symptoms of COVID-19 (including cough, malaise or fatigue, headache, sore throat, nasal congestion, chill or sweating, muscle or joint pain, chest pain, diarrhea, loss of taste and loss of smell) (4) For premenopausal female patients, patients who have been confirmed to be negative on a urine 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

(1) Fever (more than or equal to 37.5 degree celsius) more than 10 days after the onset of fever (2) Patients who have the following clinical symptoms 1), 2) and 3) 1) SpO2 less than 95% without oxygen therapy 2) Respiratory rate more than 24 breath/min 3) Blood pressure (SBP/DBP) less than 90/60 mmHg (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 (e.g., 1-3-beta glucan: 30 pg / ml or higher) (5) Patients who show, for example, abnormal NT-pro BNP levels (100 pg/mL or higher etc.) and/or 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 7 days after the end of favipiravir administration (13) Patients with hereditary xanthinuria (14) Patients who have previously ever been diagnosed with hypouricemia (less than 1 mg/dL) or xanthine urinary calculi (15) Patients receiving immunosuppressants (16) 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 degree celsius or more) or symptoms of COVID-19. (17) Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection (18) Patients who have previously received favipiravir (T-705a) (19) Other patients judged ineligible by the investigator, sub-investigator, or assigned physician (20) Patients who must take the following medication, pyrazinamide, repaglinide, theophylline, famciclovir and sulindac (21) Female patients who intend to have breastfeeding during starting favipiravir administration and until 7 days after stop favipiravir administration

2

Faculty of Medicine; Siriraj Hospital

18

74

Thailand

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

96

Time to improvement in body temperature and SpO2 without chest imaging findings, and negative SARS-C Day 1 to Day 28 Vital Sign, SpO2, and chest imaging

Phase 2/Phase 3

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