E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 Patients with Mild Pneumonia |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 Patients with Mild Pneumonia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To verify that the efficacy of favipiravir exceeds that of the supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild pneumonia, using the time required to improve clinical symptoms as the primary endpoint |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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
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E.4 | Principal 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 and are suspected to have concurrent bacterial infection (4) Patients with suspected concomitant fungal infections prior to initiation of study drug 1-3-β 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 (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
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E.5 End points |
E.5.1 | Primary end point(s) |
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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Definition of "Improvement": Body temperature, SpO2, and chest imaging findings all reach the following a) to c) and remain so for at least 2 days (not less than 48 hours) Definition of "Negative": when SARS-CoV-2 reaches d) below and remains so for more than 12 hours a) Body temperature: 37.4°C or less b) SpO2: 96% or more (without oxygen therapy) c) Improvement in chest imaging findings from the worst reading during the study d) SARS-CoV-2: negative on RT-PCR (qualitative) test
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control group (gets supportive care (symptomatic therapy)× 14 days (Maximum)) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |