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

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    1800
  • sponsor
    Chulalongkorn University
Updated on 16 November 2021

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.

Description

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.

Details
Condition Treatment outcome
Treatment FluvoxaMINE Maleate 50 MG, Fluvoxamine, Bromhexine, Fluvoxamine, Cyproheptadine, Niclosamide Pill, Niclosamide, Bromhexine
Clinical Study IdentifierNCT05087381
SponsorChulalongkorn University
Last Modified on16 November 2021

Eligibility

Yes No Not Sure

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
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