mild-to-moderate/non-severe COVID-19 COVID-19
Conditions
Interventions
Bosenbergia extract 100 mg/capsule (containing Panduratin A of at least 20 mg/capsule)
- for patients whose weights are 70 kg or below - taking per oral 3 capsules three times a day for 5 days
- fo
Experimental Drug,Active Comparator Drug
Bosenbergia extract,Favipiravir
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age at least 18 year-old 2. Diagnosed with COVID-19 by ATK or RT-PCR 3. Initial onset of symptoms attributable to COVID-19 for less than or equal to 5 days prior to the day of randomization and at least 1 symptom attributable to COVID-19 on the day of randomization (symptoms: fever, myalgia, headache, cough, sputum, rhinorrhea, nasal congestion, sore throat, dyspnea, diarrhea) 4. Mild symptoms (WHO clinical progression scale score 2-3) 5. Absence or presence of only 1 medical condition associated with an increased risk of severe illness from COVID-19: 5.1 Age more than 60 year-old 5.2 Chronic obstructive pulmonary disease (COPD) or other chronic structural lung diseases 5.3 Chronic kidney disease (CKD) stage 1-3 5.4 Coronary heart disease or congenital heart disease 5.5 Previous cerebrovascular disease 5.6 Uncontrolled diabetes 5.7 Obesity (weight more than 90 kg or body mass index (BMI)at least 30 kg per square meter) 5.8 Chronic liver disease or cirrhosis (Child-Pugh class A) 5.9 Immunocompromised state: including HIV infection, active cancer, use of corticosteroid of at least 15 mg/day of prednisolone or equivalent for at least 3 weeks, use of other immunosuppressive drug(s) 5.10 Absolute lymphocyte count less than 1,000 cells/cumm 5.11 Not receiving or receives only one shot of COVID-19 vaccine
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Breastfeeding 3. Allergic to Bosenbergia or favipiravir 4. Unable to take oral medication 5. Body weight more than 120 kg 6. estimated glomerular filtration rate (eGFR) less than 30 ml/min 7. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) more than 3 times of upper normal limits 8. Presence of lung infiltration by chest radiography (plain film) 9. Receive Bosenbergia extract within 7 days before randomization 10. Receive other antiviral agents affecting SARS-CoV-2: Nirmatrelvir/ritonavir, Molnupiravir, Remdesivir or SARS-CoV-2 specific monoclonal antibody for the current episode of COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical recovery at visit (day 1-15) case record form, days | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction day 5, 15 case record form, percentage,Development of pneumonia day 5, 15 Chest radiography, percentage,Hospitalization related to COVID-19 day 15 case record form, percentage,Death from any cause day 15 case record form, percentage,serum C-reactive protein level day 5 ELISA,Viral clearance from nasopharyngeal swab day 15 nasopharyngeal swab RT-PCR,Pharmacokinetics of serum steady states levels of Panduratin A and Pinostrobin day 5 Mass spectrometry | — |
Countries
Thailand
Contacts
Public ContactSirawat Srichatrapimuk
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed