Mild to moderate COVID-19 without high-risk features Favipiravir, Ivermectin, Niclosamide, COVID-19, SARS-CoV-2
Conditions
Interventions
The first day is a 3600 mg per day loading dose, then the maintenance dose of favipiravir is 1600 mg/day. In obese patients, favipiravir is 4800 mg on the first day as a loading dose, then the mainten
Experimental Drug,Active Comparator Drug
Favipiravir-Ivermectin-Niclosamide treatment,Favipiravir
Sponsors
National Health Foundation
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 60 years old 2. Confirmed SARS-COV-2 infected cases by Reverse Transcriptase-Polymerase Chain from a nasopharyngeal specimen whose cycle threshold value is less than 25 3. Mild to moderate COVID-19 with the duration from onset within 5 days 4. Hospitalized or outpatient treatment 5. WHO clinical progression scale within or less than 2 6. Well-Thai communication for assessing adverse events and remote communication 7. accept the informed consent
Exclusion criteria
Exclusion criteria: 1. severe or critical COVID-19 according to WHO, IDSA, and NIH definitions: SpO2 less than 95, a respiratory rate more than 30 breaths to min, or lung infiltrates more than 50 percent. 2. High-risk comorbidities including kidney injury, heart abnormalities, liver disorder, retinal disease, or investigator stratified to high-risk condition 3. ALT or AST more than 5 times upper normal limit 4. estimated GFR less than 30 5. Pregnancy or breastfeeding 6. Received antiSARSCoV2 agents less than 2 months 7. received ivermectin within 1 year before enrollment 8. He received immunosuppressive agents or immunomodulatory drugs 9. History of Favipiravir, Ivermectin, or Niclosamide allergy 10. Received upregulating of GABA, including barbiturates, benzodiazepines, sodium oxybate, valproic acid, or receiving medications that prevent or inhibit the p-glycoprotein transport system such as amiodarone, carvedilol, clarithromycin, cyclosporine, erythromycin, itraconazole, ketoconazole, quinidine, ritonavir, tamoxifen, verapamil, amprenavir, clotrimazole, phenothiazines, rifampin, St. Johns Wart 11. Participate in the other clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of viral clearance Day 1-7, 10 Cycle threshold value change or viral load | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse and serious adverse events anytimes events,WHO progeression scale non-deterioration Day 1, 3, 6, 10 WHO progeression scale,Clinical non-deterioration Day 1, 3, 6, 10 Resolution, stable, worsening | — |
Countries
Thailand
Contacts
Public ContactTaweegrit Siripongboonsitti
Chulabhorn Hospital, Chulabhorn Royal Academy
Outcome results
None listed