The Outcome of Neutralizing Monoclonal Antibodies versus Favipiravir Treatment among Mild to Moderate COVID-19 in Middle-aged Patients and Special Populations in Outpatient Clinic

Completed

• Conditions: Mild to moderate COVID-19 in those aged 40-60 years, elderly, diabetes mellitus and obesity; COVID-19, favipiravir, monoclonal antibody, SARS-CoV-2, treatment

• Registration Number: TCTR20230912002
• Lead Sponsor: Chulabhorn Royal Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1410

Inclusion Criteria

1. Confirmed SARS-COV-2 infected cases by Reverse Transcriptase-Polymerase Chain Reaction or antigen test kit who were treated with outpatients, home isolation 2. Mild to moderate COVID-19 in those aged 40-60, elderly, diabetes mellitus, and obesity 3. Participants accept informed consent 4. body weight more than 40 kilograms
5. Asymptomatic or Symptomatic by present more than or equal to one of the following symptoms: fever, runny nose, sore throat, cough, myalgia, diarrhea, chest discomfort, dyspnea
6. Chest CT severity score 0-14
7. WHO clinical progression scale < 2
8. Age more than 18 years

Exclusion Criteria

1) Respiratory tract symptoms compatible with a bacterial infection 2) Previous receiving anti-SARS-CoV-2 agents more than 24 hours
3) severe COVID-19 or signs and symptoms deterioration at the first visit; respiratory rate more than 26, oxygen saturation less than 95, hypotension defined by SBP less than 90 and DBP less than 60
4.) Need oxygen therapy
5) Pregnancy or breastfeeding
6) Who needs an increased flow of oxygen supplemental in chronic respiratory illnesses
7) Who needs hospitalization for any cause
8) Chest X-ray presents bilateral infiltration or infiltration more than 50 percent or CT chest presence crazy paving pattern or ARDS pattern or CT severity score more than 15
9) Cirrhosis child C or end-stage renal disease who did not receive hemodialysis more than 2 times a week
10) Advanced malignancy (life expectancy less than 3 months)
11) Bedridden
12) who received neutralizing monoclonal antibodies for more than 60 days
13) Casirivimab imdevimab, sotrovimab or favipiravir

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergency room visit 28 days visit times

Secondary Outcome Measures

Name	Time	Method
Hospitalization 14 and 28 days Number of admission,Oxygen supplemental 28 days Numbers,ICU admission 28 days Numbers,Clinical improvement 5, 14 days Clinical assessment, WHO clinical progression scale,Radiologic change day 5 CT severity score,Virological response 5, 14 days Cycle threshold value ,Mortality 28 days Numbers,Inflammatory marker change 5, 14 days CRP, LDH, presepsin, ESR, D-dimer,Adverse events 28 days Number of adverse events