Clinical trial NCT04940871: Study to Assess the Efficacy and Safety of Favipiravir-HU
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Favipiravir-HU Compared to Placebo as add-on Therapy to Standard of Care in Asymptomatic to Mild Severity COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Hungarian Ministry of Innovation and Technology
First posted: 2021-06-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PRIM1_ the percentage of virus copy number
timeFrame: 5 months
Secondary outcomes:
measure: SEC1_mortality rate
timeFrame: 6 months
measure: SEC2_respiratory failure
timeFrame: 6 months
measure: SEC3_ intensive care
timeFrame: 6 months
measure: SEC4_non-invasive respiratory support
timeFrame: 6 months
measure: SEC5_ invasive respiratory support
timeFrame: 6 months
measure: SEC6_ Acute Respiratory Distress Syndrome
timeFrame: 6 months
Other outcomes:
measure: KSEC1_Time to virus elimination
timeFrame: 5 months
measure: KSEC2_severe stages of COVID-19
timeFrame: 6 months
measure: KSEC3_Time to recovery
timeFrame: 6 months
measure: KSEC4_ adverse event
timeFrame: 6 months
Locations:
city: Szeged
country: Hungary
facility: University of Szeged - Internal Medicine
Study officials:
References: