COVID-19
Conditions
Interventions
Product Name: Favipiravir
Pharmaceutical Form: Tablet
INN or Proposed INN: Favipiravir
CAS Number: 259793-96-9
Current Sponsor code: na
Other descriptive name: FAVIPIRAVIR
Concentration unit: mg milli
Sponsors
Zhejiang Hisun Pharmaceutical Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures 2.Age 18-75 years (inclusive) at the time of signing ICF 3.Being confirmed with COVID-19-Moderate type according to Competent Authority and Ministry of Health and respective country guidelines and recommendations reported in Appendix 1(a, b, c, d) to the present protocol. Based on comprehensive analysis and judgement taking into account both the epidemiological history and clinical manifestations, the diagnosis is to be confirmed for suspected cases or suspected cases/clinically diagnosed cases with all of the following etiological evidences: -Positivity in RT-PCR 2019-nCov test on respiratory tract specimens; -High homology with known gene sequence of 2019-nCov in viral gene sequencing on respiratory tract specimens Note: The above criterion would be subject to any update of the respective country guidelines and recommendations reported in Appendix 1 (a, b, c, d) to the present protocol. In case any new etiologically detection methods/criteria or any new detectable specimens become available after confirmed diagnosis, it is at the discretion of the investigator whether or not to use the new methods or new specimens 4.Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia; if CT cannot be performed, Pneumonia confirmed by X-ray may be used. The method of chest imaging pneumonia diagnosis must be consistent all through the study period 5.Patients with pyrexia (axillary =37? or oral = 37.5?, or tympanic or rectal=38?) or either respiratory rate >24/min and 1 year, or having undergone chemotherapy-induced menopause with amenorrhea>1 year, or having undergone any contraceptive surgery (bilateral oophorectomy or hysterectomy) 8.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 3 months (in male) and 1 month (in female)following the last study treatment; in addition: a.For female participants of childbearing potential only h
Exclusion criteria
Exclusion criteria: 1. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely; 2. Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Favipiravir; 3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN; 4. Gout/history of gout or hyperuricemia (above the ULN); 5. Oxygen saturation (SPO2) =93% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) =300 mmHg; 6. Known allergy or hypersensitivity to Favipiravir or any of its excipients, or to placebo excipients (please see page 64); 7. Known severe renal impairment [creatinine clearance (CrCl) 1.5×ULN 8. Possibility of the subject being transferred to a non-study hospital within 72h; 9. Pregnant or lactating women; 10. Having used Favipiravir or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug or having received treatments with other Investigational Medicinal Products (IMPs) or previous therapies within two weeks or five times the half-life of the drug, whichever is longer, must lead to exclusion 11. Persons, who were placed in an institution due to official or legal orders should be excluded 12. Persons, who are dependent on the sponsor, the investigator or the trial site, meaning that the voluntary nature of their consent is no longer guaranteed, must be excluded from participation Note: Considering that COVID-19 requires immediate treatment, absence of severe hepatic/renal disorders (e.g., cirrhosis, long-term dialysis) in the medical record can be used as an evidence for eligibility determination. It is recommended that hepatic function and creatinine be examined whenever possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Time from randomization to clinical recovery Defined as: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h. Criteria for normalization or relief: - Pyrexia (body temperature): axillary =36.9?,or oral =37.4?,or rectal or axillary tympanic =37.9?; - Respiratory rate: =24/min without oxygen inhalation; - SPO2: >94% without oxygen inhalation; - Cough: Subject-perceived improvement or resolution of cough. ;Secondary Objective: Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization, Incidence of deterioration/aggravation of pneumonia within 28 days of randomization, Time from randomization to resolution of pyrexia within 28 days of randomization, Time from randomization to relief of cough within 28 days of randomization, It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0:Mild: Requires non-prescription treatment;Moderate: Requires medication treatment; limits instrumental activities of daily living;Severe: Limits self-care activities of daily living Time from randomization to relief of dyspnoea within 28 days of randomization, Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization;, ICU admission rate within 28 days of randomization, All-cause mortality within 28 days of randomization ;Primary end point(s): 1. Time from randomization to clinical recovery Defined as: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h. Criteria for normalization or relief: - Pyrexia (body temperature): axillary =36.9?,or oral =37.4?,or rectal or axillary tympanic =37.9?; - Respiratory rate: =24/mi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables: 1. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization; 2. Incidence of deterioration/aggravation of pneumonia (defined as SPO2 =93% or PaO2/FiO2 =300 mmHg or distressed RR =30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization; 3. Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization; 4. Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization; It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0: - Mild: Requires non-prescription treatment; - Moderate: Requires medication treatment; limits instrumental activities of daily living; - Severe: Limits self-care activities of daily living 5. Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization; 6. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization; 7. ICU admission rate within 28 days of randomization(except patients already enrolled in ICU which respect eligibility criteria); 8. All-cause mortality within 28 days of randomization.;Timepoint(s) of evaluation of this end point: 28 Days (+/-1) from randomization | — |
Countries
China, Germany
Contacts
Public ContactClinical Research Organization
Opera CRO Srl
Outcome results
None listed