Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Conditions
Brief summary
The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.
Interventions
DRUGFavipiravir HU 200 mg hard capsules
Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
DRUGPlacebo HU
Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules
Sponsors
Hungarian Ministry of Innovation and Technology
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients between the ages of 18 and 65 years. 2. Patients with PCR confirmed SARS-CoV-2 infection 3. Asymptomatic or have mild only symptoms and symptoms are onset less than 5 days 4. Signed Informed Consent Form and Patient Information Leaflet
Exclusion criteria
1. Pregnant or possibly pregnant patients or lactating females 2. Patients have moderate to severe or immediately life-threatening COVID-19 3. Major risk factor onset (Obesity, Diabetes, COPD, Hypertension) 4. Patients with SpO2 less than 95% without oxygen therapy 5. Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification 6. Patients with renal impairment requiring dialysis 7. Patients with disturbed consciousness such as disturbed orientation 8. 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 9. 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. 10. Patients with hereditary xanthinuria 11. Patient with severe uncontrolled hyperuricaemia 12. Patients receiving immunosuppressants 13. 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 14. Any medical condition that the examining physician deems unsuitable for the patient to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRIM1_ the percentage of virus copy number | 5 months | The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SEC2_respiratory failure | 6 months | Proportion of patients with respiratory failure |
| SEC3_ intensive care | 6 months | Proportion of patients with need for intensive care |
| SEC4_non-invasive respiratory support | 6 months | Proportion of patients with need for non-invasive respiratory support |
| SEC5_ invasive respiratory support | 6 months | Proportion of patients with need for invasive respiratory support |
| SEC6_ Acute Respiratory Distress Syndrome | 6 months | Proportion of patients with Acute Respiratory Distress Syndrome |
| SEC1_mortality rate | 6 months | Overall mortality rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| KSEC3_Time to recovery | 6 months | Time to recovery in patients who have developed symptoms |
| KSEC4_ adverse event | 6 months | Number and proportion of patients with at least 1 adverse event related to study treatment |
| KSEC2_severe stages of COVID-19 | 6 months | Proportion of patients achieving more severe stages of COVID-19 |
| KSEC1_Time to virus elimination | 5 months | Number of days from treatment start to virus elimination |
Countries
Hungary
Outcome results
None listed