Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community
1 other identifier
interventional
1,200
1 country
3
Brief Summary
There is an urgent need to identify effective treatments for SARS-CoV-2 infection that helps people recover quicker and reduces the need for hospital admission. The investigators develop an open, adaptive, platform trial to evaluate treatments, Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide suitable for use in the community for treating COVID-like-illness that might help people recover sooner and prevent hospitalisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2021
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2022
CompletedNovember 4, 2022
November 1, 2022
9 months
October 19, 2021
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hospital admission or mortality related to COVID-19
Contacts with health services reported by patients and/or captured by reports of patients' medical records
Within 28 days
Time taken to self- report recovery
Patient reports the day they feel recovered
Enrolment through final day of participation
Progression to severe COVID-19 Disease
O2 saturation \<92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death.
Enrolment through final day of participation
Secondary Outcomes (4)
Reduction (change) in GI viral shedding (by PCR)
Days 0,7,14
Change in respiratory viral clearance (by PCR)
Days 0,7,14
Time to resolution of a fever
Enrolment through final day of participation
Negative effects on well being
Days 0,7,15,28,60
Other Outcomes (1)
Incidence of Adverse Events (AEs)
Enrolment through 30 days after final day of participation
Study Arms (6)
Fluvoxamine Arm
EXPERIMENTALThe 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.
Fluvoxamine in Combination with Bromhexine Arm
EXPERIMENTALThe 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.
Fluvoxamine in Combination with Cyproheptadine Arm
EXPERIMENTALThe 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.
Niclosamide Arm
EXPERIMENTALThe 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.
Niclosamide in Combination with Bromhexine Arm
EXPERIMENTALThe 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.
Usual Care Arm
NO INTERVENTIONThe control group received treatment according to the latest usual care medical guidelines provide by ministry of Thailand at that time.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- COVID-1 9 patients with mild symptoms and the results were confirmed by Antigen Test Kit or PCR for SARS-CoV-2.
- People who have symptoms consistent with COVID-19 and test positive for SARS-CoV-2 infection within 48 hours of being known.
- Participants are 18 years of age or older.
You may not qualify if:
- Almost recovered (generally much improved and symptoms now mild or almost absent)
- Judgement of the recruiting clinician deems ineligible.
- Previous randomisation to an arm of the trial
- Pregnancy
- Breastfeeding
- Known severe hepatic impairment.
- Known severe renal impairment.
- Currently taking Fluvoxamine, Bromhexine, Cyproheptadine, or Niclosamide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Department of Medical Services Ministry of Public Health of Thailandcollaborator
- Ministry of Health, Thailandcollaborator
- Mahidol Universitycollaborator
- Ramathibodi Hospitalcollaborator
- QIMR Berghofer Medical Research Institutecollaborator
- Yamagata Prefectural Central Hospitalcollaborator
- The University of Western Australiacollaborator
- Mae Fah Luang Universitycollaborator
- King Chulalongkorn Memorial Hospitalcollaborator
- Washington University School of Medicinecollaborator
- Vibhavadi Hospitalcollaborator
- Thanyarak Pattani Hospitalcollaborator
Study Sites (3)
Rajvithi Hospital
Ratchathewi, Bangkok, 10400, Thailand
Vibhavadi Hospital
Bangkok, 10900, Thailand
Chiangmai Neurological Hospital
Chiang Mai, 50200, Thailand
Related Publications (1)
Wannigama DL, Hurst C, Phattharapornjaroen P, Hongsing P, Sirichumroonwit N, Chanpiwat K, Rad S M AH, Storer RJ, Ounjai P, Kanthawee P, Ngamwongsatit N, Kupwiwat R, Kupwiwat C, Brimson JM, Devanga Ragupathi NK, Charuluxananan S, Leelahavanichkul A, Kanjanabuch T, Higgins PG, Badavath VN, Amarasiri M, Verhasselt V, Kicic A, Chatsuwan T, Pirzada K, Jalali F, Reiersen AM, Abe S, Ishikawa H; COVID-EarlyMed Trial Team. Early treatment with fluvoxamine, bromhexine, cyproheptadine, and niclosamide to prevent clinical deterioration in patients with symptomatic COVID-19: a randomized clinical trial. EClinicalMedicine. 2024 Mar 14;70:102517. doi: 10.1016/j.eclinm.2024.102517. eCollection 2024 Apr.
PMID: 38516100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dhammika Leshan Wannigama, MD PhD
Chulalongkorn University
- STUDY CHAIR
Cameron Hurst, PhD
QIMR Berghofer Medical Research Institute
- STUDY CHAIR
Kanokpoj Chanpiwat, MD
Rajvithi Hospital
- STUDY CHAIR
Shuichi Abe, MD
Yamagata Prefectural Central Hospital
- STUDY DIRECTOR
Katika Akksilp, MD
Ministry of Health, Thailand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow and Scientist
Study Record Dates
First Submitted
October 19, 2021
First Posted
October 21, 2021
Study Start
October 1, 2021
Primary Completion
June 21, 2022
Study Completion
June 21, 2022
Last Updated
November 4, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share