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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20230912002
Enrollment
192
Registered
2023-09-12
Start date
2021-09-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

loading dose of oral favipiravir 3600 mg on the initial day, then 1600 mg per day for 4 days (total 5 days) In obese patients, a loading dose of oral favipiravir 4800 mg on the initial day, then 2000
Treatment,Treatment
Favipiravir treated group,Neutralizing monoclonqal antibodies

Sponsors

Chulabhorn Royal Academy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Emergency room visit 28 days visit times

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactTaweegrit Siripongboonsitti

Chulabhorn Royal Academy

Taweegrit.sir@cra.ac.th0816924872

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026