COVID-19 Patients without Pneumonia
Conditions
Sponsors
Vilnius University Hospital Santaros klinikos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 74 years (at the time of informed consent) (2) Gender: Male or female (3) Patients who meet all of the following criteria 1), 2), and 3) at the time of enrollment 3.1) Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT-PCR test 3.2) Patients without new lung lesions on chest images that are compatible with pneumonia 3.3) Patients with a fever of 37.5°C or more (4) For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug (5) Patients who understand the contents of this study and are able to provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: (1) Fever (37.5°C) more than 10 days after the onset of fever (2) Patients with SpO2 less than 95% without oxygen therapy (3) Patients who show increased procalcitonin levels before the start of study drug administration and are suspected to have concurrent bacterial infection (4) Patients with suspected concomitant fungal infections prior to initiation of study drug (for example 1-3-ß glucan: 30 pg/ml or higher) (5) Patients who show, for example, abnormal NT-pro BNP levels (100 pg/mL or higher) and are suspected to have concurrent congestive heart failure (6) Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification (7) Patients with renal impairment requiring dialysis (8) Patients with disturbed consciousness such as disturbed orientation (9) Pregnant or possibly pregnant patients (10) Female patients who are unable to consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 14 days after the end of favipiravir administration. (11) Male patients whose partner cannot agree to use the contraception method described in (10) above (12) Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration (13) Female patients who intend to breastfeed from start of favipiravir administration until 14 days after discontinuation of favipiravir administration (14) Patients with hereditary xanthinuria (15) Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi (16) Patients with a history of gout or on treatment for gout or hyperuricemia (17) Patients receiving immunosuppressants (18) Patients who have 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 9 days after fever (37.5°C or more). (19) Patients in whom this episode of infection is a recurrence or reinfection of SARS-CoV-2 infection (20) Patients who have previously received favipiravir (T-705a) (21) Other patients judged ineligible by the investigator, sub-investigator, or assigned physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify that the efficacy of favipiravir exceeds that of the supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) without pneumonia, using the time required to improve clinical symptoms as the primary endpoint;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the time from initiation of the study drug to the time of “improvement” in body temperature, SpO2, and chest imaging and negative SARS-CoV-2.;Timepoint(s) of evaluation of this end point: Definition of "Improvement": Body temperature, SpO2, and chest imaging findings all reach the following a) to c) and remain so for at least 2 days (not less than 48 hours) Definition of "Negative": when SARS-CoV-2 reaches d) below and remains so for more than 12 hours a) Body temperature: 37.4°C or less b) SpO2: 96% or more (without oxygen therapy) c) Improvement in chest imaging findings from the worst reading during the study d) SARS-CoV-2: negative on RT-PCR (qualitative) test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Changes in patient status on a 5-point scale (2) Changes in the level of SARS-CoV-2 viral genome (3) Time to disappearance of SARS-CoV-2 (4) Duration of pyrexia, SpO2, and chest imaging findings (5) Changes in clinical symptoms (6) Changes in vital signs (7) Changes in NEWS (National Early Warning Score) (8) Changes in chest imaging findings on Days 4,7,10,13,16,19,22,25,28. (9) Percentage of patients requiring adjuvant oxygen therapy and average duration (10) Percentage of patients requiring mechanical ventilation therapy and average duration (11) White blood cell count, hemoglobin, platelet count, creatinine, blood glucose, total bilirubin, ALT, and AST over time as a part of the clinical laboratory evaluation ;Timepoint(s) of evaluation of this end point: Because this is a study to be conducted during the COVID-19 pandemic, the items that can be routinely evaluated in the clinical practice related to the chief complaint of general respiratory symptoms have been selected as endpoints in consideration of their imposed burden in the clinical setting. | — |
Countries
Lithuania
Contacts
Public ContactNational coordinator
Vilnius University Hospital Santaros klinikos
Outcome results
None listed