Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Phase 2NCT04940871
Study to Assess the Efficacy and Safety of Favipiravir-HU
A Phase 2 study testing Favipiravir HU 200 mg hard capsules in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- What is being tested?
- Favipiravir HU 200 mg hard capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteHungary
- Study dates
- 25 Nov 2021to 29 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Favipiravir HU 200 mg hard capsules, Placebo HU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favipiravir HU 200 mg hard capsulesDrug
Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
Placebo HUDrug
Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir HU + SOC | Experimental | Favipiravir HU + SOC Receives: Drug: Favipiravir HU 200 mg hard capsules |
| Placebo HU + SOC | Placebo comparator | Placebo HU + SOC Receives: Drug: Placebo HU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (6)
SEC1_mortality rate
Overall mortality rate
Measured: 6 months
SEC2_respiratory failure
Proportion of patients with respiratory failure
Measured: 6 months
SEC3_ intensive care
Proportion of patients with need for intensive care
Measured: 6 months
SEC4_non-invasive respiratory support
Proportion of patients with need for non-invasive respiratory support
Measured: 6 months
SEC5_ invasive respiratory support
Proportion of patients with need for invasive respiratory support
Measured: 6 months
SEC6_ Acute Respiratory Distress Syndrome
Proportion of patients with Acute Respiratory Distress Syndrome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 Nov 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Why it stopped: Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Innovation and Technology, Hungary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940871
- Sponsor's protocol ID
- HUN-FAVI-02
- Status last verified
- Nov 2022
- First submitted
- 20 May 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04940871
- Acronym / sponsor ID
- HUN-FAVI-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Ministry of Innovation and Technology, Hungary
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir HU + SOC | Experimental | Drug: Favipiravir HU 200 mg hard capsulesFavipiravir HU + SOC |
| Placebo HU + SOC | Placebo comparator | Drug: Placebo HUPlacebo HU + SOC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Favipiravir HU 200 mg hard capsulesDrug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules | Drug | Favipiravir HU + SOC |
| Placebo HUName: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules | Drug | Placebo HU + SOC |
Primary outcome
PRIM1_ the percentage of virus copy number
Time frame: 5 months
The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
6 secondary outcomes
SEC1_mortality rate
Time frame: 6 months
SEC2_respiratory failure
Time frame: 6 months
SEC3_ intensive care
Time frame: 6 months
SEC4_non-invasive respiratory support
Time frame: 6 months
SEC5_ invasive respiratory support
Time frame: 6 months
SEC6_ Acute Respiratory Distress Syndrome
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Favipiravir HU 200 mg hard capsules in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIM1_ the percentage of virus copy number (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.