Back to resultsStudy to Assess the Efficacy and Safety of Favipiravir-HU
Primary Purpose
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Status
Terminated
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
Favipiravir HU 200 mg hard capsules
Placebo HU
Sponsored by
About this trial
This is an interventional treatment trial for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Eligibility Criteria
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 and symptoms are onset less than 5 days
- Signed Informed Consent Form and Patient Information Leaflet
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 immunosuppressants
- 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
Sites / Locations
- University of Szeged - Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Favipiravir HU + SOC
Placebo HU + SOC
Arm Description
Favipiravir HU + SOC
Placebo HU + SOC
Outcomes
Primary Outcome Measures
PRIM1_ the percentage of virus copy number
The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
Secondary Outcome Measures
SEC1_mortality rate
Overall mortality rate
SEC2_respiratory failure
Proportion of patients with respiratory failure
SEC3_ intensive care
Proportion of patients with need for intensive care
SEC4_non-invasive respiratory support
Proportion of patients with need for non-invasive respiratory support
SEC5_ invasive respiratory support
Proportion of patients with need for invasive respiratory support
SEC6_ Acute Respiratory Distress Syndrome
Proportion of patients with Acute Respiratory Distress Syndrome
Full Information
NCT ID
NCT04940871
First Posted
May 20, 2021
Last Updated
November 4, 2022
Sponsor
University of Pecs
Collaborators
Hungarian Ministry of Innovation and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04940871
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs
Collaborators
Hungarian Ministry of Innovation and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blinded
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Favipiravir HU + SOC
Arm Type
Experimental
Arm Description
Favipiravir HU + SOC
Arm Title
Placebo HU + SOC
Arm Type
Placebo Comparator
Arm Description
Placebo HU + SOC
Intervention Type
Drug
Intervention Name(s)
Favipiravir HU 200 mg hard capsules
Intervention Description
Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
Intervention Type
Drug
Intervention Name(s)
Placebo HU
Intervention Description
Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules
Primary Outcome Measure Information:
Title
PRIM1_ the percentage of virus copy number
Description
The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
SEC1_mortality rate
Description
Overall mortality rate
Time Frame
6 months
Title
SEC2_respiratory failure
Description
Proportion of patients with respiratory failure
Time Frame
6 months
Title
SEC3_ intensive care
Description
Proportion of patients with need for intensive care
Time Frame
6 months
Title
SEC4_non-invasive respiratory support
Description
Proportion of patients with need for non-invasive respiratory support
Time Frame
6 months
Title
SEC5_ invasive respiratory support
Description
Proportion of patients with need for invasive respiratory support
Time Frame
6 months
Title
SEC6_ Acute Respiratory Distress Syndrome
Description
Proportion of patients with Acute Respiratory Distress Syndrome
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
KSEC1_Time to virus elimination
Description
Number of days from treatment start to virus elimination
Time Frame
5 months
Title
KSEC2_severe stages of COVID-19
Description
Proportion of patients achieving more severe stages of COVID-19
Time Frame
6 months
Title
KSEC3_Time to recovery
Description
Time to recovery in patients who have developed symptoms
Time Frame
6 months
Title
KSEC4_ adverse event
Description
Number and proportion of patients with at least 1 adverse event related to study treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 and symptoms are onset less than 5 days
Signed Informed Consent Form and Patient Information Leaflet
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 immunosuppressants
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
Facility Information:
Facility Name
University of Szeged - Internal Medicine
City
Szeged
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Assess the Efficacy and Safety of Favipiravir-HU
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