Efficacy of Combined Convalescent Plasma Therapy with Oral RNA-dependent RNA Polymerase Inhibitor versus Monoclonal Neutralizing Antibody Therapy among Mild to Moderate COVID-19 in Outpatients: Multicenter, Non-inferiority, Open-label Randomized Controlled Trial (PlasMab trail)

Chulabhorn Royal Academy0 sites136 target enrollmentMarch 19, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 19, 2022

End Date

April 23, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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

•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