COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20220319002

Taweegrit Siripongboonsitti

taweegrit.sir@cra.ac.th

2022-03-19

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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 &lt,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 &lt, /= 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 &gt,/= 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

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

2

Chulabhorn Royal Academy

20

100

Thailand

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

136

Prevention of hospitalization 14 days Non inferiority

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2432, "treatment_name": "Convalescent plasma+favipiravir", "treatment_type": "Convalescent plasma+antivirals", "pharmacological_treatment": "Biological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]