Mild to moderate COVID-19 (non-severe COVID-19) COVID-19, SARS-CoV-2, favipiravir, sotrovimab, convalescent plasma therapy, monoclonal neutralizing antibody
Conditions
Interventions
ABO blood group compatible high neutralizing antibodies titer (equal or more than 1 per 320) COVID19 Convalescent plasma (CCP) from National Blood Centre Thai Red Cross Society from male donors with p
Experimental Drug,Active Comparator Drug
High neutralizing antibodies titer of COVID19 convalescent plasma therapy plus favipiravir,Sotrovimab
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age equal or more than 20 years 2. Body weigh equal or more than 40 kilograms 3. SARS-CoV-2 detected from nasopharyngeal specimen by antigen test kit and confirmed with SARS-CoV-2 PCR 4. Symptomatic equal or less than 7 days after onset of a symptom: At least one of the following symptom; fever, cough, runny nose, sore throat, dyspnea, chest discomfort, diarrhea 5. Absence or presence <50%of pneumonia from chest X-ray or presence of pneumonia from chest CT with overall CT severity score 1-14 (mild to moderate pneumonia) 6. WHO clinical progression scale < /= 3 7. Thai language communicable 8. Accept to follow up according to outpatient treatment or home isolation protocol 9. At least one of the following risk factor to deteriorate to severe illness: age more than 60 years, obesity or BMI >/= 30 kg/ m2, diabetes mellitus, chronic kidney disease, heart disease and cardiovascular disease, COPD/ asthma, hypertension, liver disease with child pugh score A-B, receiving immunosuppressive therapy, cerebrovascular accident/stroke, intellectual disabilities, cancer with life expectancy more than 3 months, patients who disabilities and need medical intervention include tracheostomy, gastrostomy 10. Accept the informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Severe illness: including pneumonia with the following condition 2.1 Respiratory rates more than 24 per minute 2.2 Oxygen saturation less than 95% 3. Need for oxygen therapy 4. chronic oxygen therapy with the need to increase oxygen flow from the other pulmonary disease except from COVID-19 5. Patient who need hospitalization 6. Chest X-ray showed more than 50% bilateral infiltration, or chest CT showed multifocal consolidation, crazy paving pattern, ARDS 7. Intake the other anti-SARS-CoV-2 therapy more than 24 hours 8. Child-Pugh score C or end-stage-renal disease without dialysis or hemodialysis less than two times/week 9. Advanced stage cancer or palliative treatment (with life expectancy less than three months) 10. Bed-ridden and need hospitalization 11. Received neutralizing monoclonal antibody or plasma in 60 days 12. severe allergic reaction to favipiravir or sotrovimab 13. History of severe transfusion reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of hospitalization 14 days Non inferiority | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention of hospitalization 28 days Rate of hospitalization,Supplemental oxygen 14 days, 28 days Rate of Supplemental oxygen,Hospitalization and/or emergency department visit 14 days, 28 days Rate of hospitalization and emergency department visit,Emergency department visit 28 days Rate of emergency department visit,Mortality 14 days, 28 days Mortality rate,Length of stay 28 days Number of days of admission,Prevent deterioration day 2, 5, 14 No symptom deterioration,Improvement of radiologic pulmonary involvement Day 5, 14 Decrease pulmonary infiltration in COVID-19 pneumonia,Prevent radiologic progression Day 5, 14 Progression of pneumonia,Efficacy in different variant of concern Day 2, 5, 14 Clinical and radiologic improvement/ progression,Biomarkers 0, 2, 5, 14 days Change in biomarker levels,Virologic response/ clearance 0, 5, 14 days Change in Cycle threshold value,Level of SARS-CoV-2 antibody 0, 2, 5, 14 days Change in antibody level,Adverse events and side effects 0, 2, 5, 14 dys Rate of adverse events | — |
Countries
Thailand
Contacts
Public ContactTaweegrit Siripongboonsitti
Chulabhorn Royal Academy
Outcome results
None listed