This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy of Favipiravir combined with supportive care for adult patients with COVID-19-Moderate type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
Favipiravir combined with supportive care recommended in the current National/Local guidelines. Favipiravir dosage and method of administration: Day 1 1800 mg x2; Day 2 up to a maximum of 14 days 600 mg x 3
Placebo combined with supportive care recommended in the current National/Local guidelines. Placebo dosage and method of administration: Day 1 1800 mg x2; Day 2 up to a maximum of 14 days 600 mg x 3
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Shangcheng District, China
Peking University First Hospital
Beijing, Xicheng District, China
Department of Internal Medicine Pneumology and infectious diseases Neukölln Clinic
Berlin, Germany
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 72h. Criteria for normalization or relief: * Pyrexia (body temperature): axillary ≤37℃,or oral≤37.5℃,or rectal or tympanic ≤38℃; * Respiratory rate: ≤24/min without oxygen inhalation; * SPO2: \>94% without oxygen inhalation; * Cough: Subject-perceived improvement or resolution of cough.
Time frame: 28 days
Negativity in RT-PCR nucleic acid test
Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov 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
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;
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical clinic and polyclinic IV Hospital of the University of Munich
München, Germany
Infectious Diseases Hospital Cluj-Napoca
Cluj-Napoca, Cluj, Romania
National Institute of Infectious Diseases "Prof.Dr.Matei Bals"
Bucharest, Ilfov, Romania
"Dr.Victor Babes" Infectious Diseases and Pneumoftiziology Clinical Hospital Timisoara
Timișoara, Timiș County, Romania
"Dr.Victor Babes" Infectious Diseases and Pneumoftiziology Clinical Hospital Timisoara
Timișoara, Timiș County, Romania
Dr.Victor Babes Infectious Diseases and Pneumoftiziology Clinical Hospital Timisoara
Timișoara, Timiș County, Romania
Emergency County Hospital "Pius Brinzeu"Timisoara
Timișoara, Timiș County, Romania
Time frame: 28 days
Time from randomization to relief of dyspnoea
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 or non-invasive ventilation
Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization;
Time frame: 28 days
ICU admission rate within 28 days of randomization
ICU admission rate within 28 days of randomization (except patients already enrolled in ICU which respect eligibility criteria);
Time frame: 28 days
All-cause mortality within 28 days of randomization.
All-cause mortality within 28 days of randomization.
Time frame: 28 days