Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community

PHASE4CompletedINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

June 21, 2022

Study Completion Date

June 21, 2022

Conditions
Treatment Efficacy
Interventions
DRUG

FluvoxaMINE Maleate 50 MG

"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime.~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."

COMBINATION_PRODUCT

Fluvoxamine, Bromhexine

"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."

COMBINATION_PRODUCT

Fluvoxamine, Cyproheptadine

"The subjects received fluvoxamine (immediate release) 50 mg, 1 tablet in the morning and 50 mg 2 tablets before bedtime, orally after meals. For a total of 14 days, the first two days and the last two days, 50 mg 1 tablet in the morning and 50 mg 1 tablet at bedtime. Co- administration with cyproheptadine 4 mg, 1 tablet, three times, orally after meals and should be taken every 8 hours apart, for 14 days.~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."

DRUG

Niclosamide Pill

"The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days.~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."

COMBINATION_PRODUCT

Niclosamide, Bromhexine

"The subjects received 1 tablet of niclosamide 1000 mg orally in divided doses twice a day. After meals in the morning and evening for a total of 14 days. Co-administration with bromhexine 8 mg, 1 tablet twice taken after meals and taken at least 8 hours apart, for 10 days.~All enrolled patients will be provided a thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. In addition, Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 0, 7 and 14. Fecal and blood samples will be collected for viral shedding as measured by PCR on days 0,7 and 14. A baseline fecal and oropharyngeal sample will be obtained on Day 0 prior to starting dosing of drugs."

Trial Locations (3)

10400

Rajvithi Hospital, Ratchathewi

10900

Vibhavadi Hospital, Bangkok

50200

Chiangmai Neurological Hospital, Chiang Mai

All Listed Sponsors
collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

collaborator

Ministry of Health, Thailand

OTHER_GOV

collaborator

Mahidol University

OTHER

collaborator

Ramathibodi Hospital

OTHER

collaborator

QIMR Berghofer Medical Research Institute

OTHER

collaborator

Yamagata Prefectural Central Hospital

UNKNOWN

collaborator

The University of Western Australia

OTHER

collaborator

Mae Fah Luang University

OTHER

collaborator

King Chulalongkorn Memorial Hospital

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Vibhavadi Hospital

UNKNOWN

collaborator

Thanyarak Pattani Hospital

UNKNOWN

lead

Chulalongkorn University

OTHER

NCT05087381 - Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community | Biotech Hunter | Biotech Hunter