Covid19
Conditions
Keywords
COVID-19, Favipiravir, oseltamivir, adjuvant, effectivity
Brief summary
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
Detailed description
This open-label trial aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)
Interventions
DRUGFavipiravir
The favipiravir group received loading dose of 1600 mg twice a day (3200 mg/day) on the first day and continued with 600 mg twice a day (1200 mg/day) for the next 2nd - 7th day in addition to the standard therapy. Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
DRUGOseltamivir 75mg
The oseltamivir group was given twice a day of 75 mg of oseltamivir (150 mg/day) for 7 days in addition to standard therapy Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be divided into two groups: favipiravir and oseltamivir as adjuvant therapy in addition to standard therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. adult patients aged 18-75 years old 2. Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR COVID-19 IgM/IgG rapid test 3. No history of favipiravir or oseltamivir allergy 4. Consented to participate in the trial.
Exclusion criteria
1. Pregnant women 2. Breastfeeding mother 3. Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times from baseline level 4. Reduced kidney function with estimated glomerular filtration rate (eGFR) \<30 mL/min OR serum creatinine \> 2 mg/dL 5. Patients with history of heart failure 6. Tuberculosis infection that was treated with pyrazinamide 7. Asthma that was treated with theophylline 8. Type 2 diabetes that was treated with repaglinid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical radiologic changes | 14 days | Changes of lung infiltrate in chest xray AND/OR GGO in chest CT scan after 14 days of follow up period This outcome measured will displayed as improvement/no changes/deterioration of radiologic examination results |
| Percentage of RT-PCR test convertion | 14 days | Convertion of RT-PCR swab result from positive to negative at the end of 14 days study follow up This outcome measured will displayed as convertion OR no conversion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 14 days | Mild to moderate adverse event serious adverse event such as sever allergy and increased transaminase enzyme \>3x normal limit |
| Hospital length of stay (LOS) | 14 days | Days of hospitalization from the first dose of intervention |
| Case Fatality Rate (CFR) | 14 days | CFR is calculated from mortality rate during hospital admission |
Countries
Indonesia
Contacts
Primary ContactDante S Harbuwono, MD, PhD
Backup ContactCleopas M Rumende, MD, PhD
Outcome results
None listed