An Investigation of the Efficacy and Safety of Favipiravir in Hospitalized NON- SEVERE COVID-19 Patients - An Open-label Randomized Controlled Multi Center Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University of the Philippines
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Time from initiation of treatment to clinical improvement
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Detailed Description
Favipiravir is an antiviral agent whose indication in Japan is currently for influenza infections. There were earlier reports from China suggesting its promising potential for benefit in the treatment of COVID-19. This is an open label randomized controlled clinical trial was designed to verify the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care. This study will look at the potential of using this repurposed oral agent in managing non-severe cases of COVID19. Consenting patients admitted to hospitals or isolation/quarantine facilities will be randomized at a 2:1 ratio to either favipiravir versus best supportive care. Patients will be examined daily and will have xray and nasopharyngeal swabs every 3-4 days for close monitoring.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 to 74 years (at the time of informed consent)
- •Gender: Male or female
- •Patients with SARS-CoV-2-positive nasopharyngeal swab by RT-PCR test with non-severe presentation upon admission to clinical trial site hospitals or trial-supervised quarantine facilities or under trial -supervised home isolation;
- •For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug;
- •Patients who understand the contents of this study and can provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents
Exclusion Criteria
- •Patient has manifestation that meets case definition of Severe COVID-19: Adult with clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) plus one of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; or SpO2 \< 90% on room air.
- •Fever (37.5°C) more than 7 days after the onset of fever
- •Patients with suspected concomitant bacterial infections (e.g. 1 ng/ml or higher procalcitonin, etc.) prior to initiation of study drug
- •Patients with suspected concomitant fungal infections (e.g. 30 pg/ml or higher (1-3)-β-d-glucan, etc.) prior to initiation of study drug
- •Patients with suspected concurrent congestive heart failure (e.g. 100 pg/mL or higher NT-pro BNP levels, etc.) prior to initiation of study drug
- •Patients with severe hepatic impairment (\>Grade 3: ALT \>10 times of upper normal limit)
- •Patients with renal impairment requiring dialysis
- •Patients with disturbed consciousness such as disturbed orientation
- •Pregnant or possibly pregnant patients
- •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 during the 7 days after the start of favipiravir administration.
Outcomes
Primary Outcomes
Time from initiation of treatment to clinical improvement
Time Frame: 4 to 28 days
The duration from start of treatment (Favipiravir + Standard of care compared to Standard of care) to clinical improvement and maintained for at least 48 hours. Criteria for clinical improvement include all three must be reached: Body temperature: axillary ≤37.4°C Oxygen saturation measured by pulse oximeter of \>96% without oxygen inhalation Chest imaging findings with changes showing improvement
Secondary Outcomes
- Clinical effect of Favipiravir + Standard of Care compared to Standard of Care on patient status as measured by 7-point scale(4 to 14 days of therapy)
- Number of participants with conversion to negative level of SARS-COV2 viral genome(4 to 14 days of therapy)
- Number of participants with Changes in NEWS (National Early Warning Score)(4 to 14 days of therapy)
- Number of participants with improvement in chest imaging findings(4 to 14 days of therapy)