This study evaluates treatment with Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.
This is a double-blind, placebo controlled, multicenter study that evaluates the performance and safety of the Favipiravir combined with supportive care for adult patients with COVID-19-moderate type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Dosage and method of administration: Day 1: 1800mg, BID; Day 2 and thereafter: 600mg, TID, for a maximum of 14 days. Where the subject has experienced an adverse event related to liver injury of grade≥3 (NCI CTCAE v5.0), the dose is to be reduced to 600mg BID. It is at the discretion of the investigator whether or not to perform dose reduction based on how the subject is benefiting from study treatment. The subject should be discontinued from treatment if he/she re-experiences any adverse event related to liver injury of grade≥3 after dose reduction
Dosage and method of administration: Day 1: 1800mg, BID; Day 2 and thereafter: 600mg, TID, for a maximum of 14 days. Where the subject has experienced an adverse event related to liver injury of grade≥3 (NCI CTCAE v5.0), the dose is to be reduced to 600mg BID. It is at the discretion of the investigator whether or not to perform dose reduction based on how the subject is benefiting from study treatment. The subject should be discontinued from treatment if he/she re-experiences any adverse event related to liver injury of grade≥3 after dose reduction
Asst Fatebenefratelli Sacco
Milan, Italy
Time from randomization to clinical recovery
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 72 hours.
Time frame: 90 days
Time from randomization to negativity in RT-PCR nucleic acid test
1\. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;
Time frame: 28 days
Incidence of deterioration/aggravation of pneumonia
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;
Time frame: 28 days
Time from randomization to resolution of pyrexia
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;
Time frame: 28 days
Time from randomization to relief of cough
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
Time frame: 28 days
Time from randomization to relief of dyspnoea
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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;
Time frame: 28 days
Rate of auxiliary oxygen therapy
6\. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization
Time frame: 28 days
ICU admission rate
ICU admission rate within 28 days of randomization
Time frame: 28 days
Mortality
All-cause mortality within 28 days of randomization
Time frame: 28 days