|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Patients with PCR confirmed SARS-CoV-2 infection who are
asymptomatic or have mild symptoms will be enrolled
|Medical condition in easily understood language
|Patients with confirmed COVID-19 disease
|Diseases [C] - Virus Diseases [C02]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|10021881 - Infections and infestations
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|The primary objective is to assess the efficacy of Favipiravir-HU compared to placebo as add-on treatment on reducing SARS-CoV-2 virus copy number as measured by quantitative PCR by nasopharyngeal sampling.
|Secondary objectives of the trial
|Key secondary objectives
• To assess the study treatment’s effect on reduction of the time required for virus elimination.
• To assess the study treatment’s risk reduction effect.
• To assess the recovery time in patients who have developed symptoms, using clinical and radiological diagnostics
• To evaluate the safety and tolerability of the investigational product.
• To assess the study treatment’s risk reduction effect on overall mortality.
• To assess the study treatment’s risk reduction effect on achieving development of respiratory failure.
• To assess the study treatment’s risk reduction effect on need for intensive care unit.
• To assess the study treatment’s risk reduction effect on need for non-invasive respiratory support.
• To assess the study treatment’s risk reduction effect on need for invasive respiratory support.
• To assess the study treatment’s risk reduction effect on Acute Respiratory Distress Syndrome.
|Trial contains a sub-study
|Principal inclusion criteria
| Male or female patients between the ages of 18 and 65 years
Patients with PCR confirmed SARS-CoV-2 infection
Asymptomatic or have mild only symptoms
Signed Informed Consent Form and Patient Information Leaflet
|Principal exclusion criteria
| Pregnant or possibly pregnant patients or lactating females
Patients have moderate to severe or immediately life-threatening COVID-19
Major risk factor onset (Obesity, Diabetes, COPD, Hypertension)
Patients with SpO2 less than 95% without oxygen therapy
Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
Patients with renal impairment requiring dialysis
Patients with disturbed consciousness such as disturbed orientation
Female patients who are woman of childbearing potential and unable to consent to 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 orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation
Male patients whose are unable to consent to use of 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 in 90 days after the start of favipiravir administration.
Patients with hereditary xanthinuria
Patient with severe uncontrolled hyperuricaemia
Patients receiving immunosuppressant
Patients who 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 72 hours or Patients who receive forbidden concomitant medication
Any medical condition that the examining physician deems unsuitable for the patient to participate in the study
|E.5 End points
|Primary end point(s)
|<PRIM1> The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
|Timepoint(s) of evaluation of this end point
|Secondary end point(s)
|<KSEC1> Time to virus elimination: number of days from treatment start to virus elimination
<KSEC2> Proportion of patients achieving more severe stages of COVID-19
<KSEC3> Time to recovery in patients who have developed symptoms
<KSEC4> Number and proportion of patients with at least 1 adverse event related to study treatment
Secondary endpoints of the study are as follows:
<SEC1> Overall mortality rate
<SEC2> Proportion of patients with respiratory failure
<SEC3> Proportion of patients with need for intensive care
<SEC4> Proportion of patients with need for non-invasive respiratory support
<SEC5> Proportion of patients with need for invasive respiratory support
<SEC6> Proportion of patients with Acute Respiratory Distress Syndrome
|Timepoint(s) of evaluation of this end point
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days