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Completed

NCT Number: NCT05087381

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rajvithi Hospital, Ratchathewi, Bangkok, Thailand

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About this study

There is an urgent need to identify interventions against COVID-19 suitable for wide use in the community that have been proven to be effective in reducing symptom duration or hospitalisation. There is urgent need to know whether potential COVID-19 treatments such as Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide that are available for rapid pragmatic evaluation might modify the course of COVID-19 infections, particularly among those who are at higher risk of complications, such as those aged 50 years and over with comorbidity and those aged 65 years and over.

Most reported trials have been conducted in hospital settings, and there is little evidence from community settings, where most people with COVID-19 receive care and where deployment of effective early treatment could speed time to recovery and reduce complications. The investigators established a multi-arm, adaptive platform, randomised controlled trial for community treatment of COVID-19 syndromic illness in people at higher risk of an adverse illness course.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

FluvoxaMINE Maleate 50 MG

Drug

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.

Other names: Telehealth monitoring

Fluvoxamine, Bromhexine

Combination Product

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.

Other names: Telehealth monitoring

Fluvoxamine, Cyproheptadine

Combination Product

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.

Other names: Telehealth monitoring

Niclosamide Pill

Drug

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.

Other names: Telehealth monitoring

Niclosamide, Bromhexine

Combination Product

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.

Other names: Telehealth monitoring

Primary outcomes

  1. Hospital admission or mortality related to COVID-19

    Time frame: Within 28 days

    Contacts with health services reported by patients and/or captured by reports of patients' medical records

  2. Time taken to self- report recovery

    Time frame: Enrolment through final day of participation

    Patient reports the day they feel recovered

  3. Progression to severe COVID-19 Disease

    Time frame: Enrolment through final day of participation

    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.

Secondary outcomes

  1. Reduction (change) in GI viral shedding (by PCR)

    Time frame: Days 0,7,14

    Fecal swabs

  2. Change in respiratory viral clearance (by PCR)

    Time frame: Days 0,7,14

    Oropharyngeal swabs

  3. Time to resolution of a fever

    Time frame: Enrolment through final day of participation

    Online diary

  4. Negative effects on well being

    Time frame: Days 0,7,15,28,60

    WHO 5 Well Being Index via online diary or telephone

Other outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Enrolment through 30 days after final day of participation

    Composite counts by Adverse Events and Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand
  • King Chulalongkorn Memorial Hospital
  • Mae Fah Luang University
  • Mahidol University
  • Ministry of Health, Thailand
  • QIMR Berghofer Medical Research Institute
  • Ramathibodi Hospital
  • Thanyarak Pattani Hospital
  • The University of Western Australia
  • Vibhavadi Hospital
  • Washington University School of Medicine
  • Yamagata Prefectural Central Hospital

Registry information

Official study title

Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community With Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide in Decreasing Recovery Time

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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