Clinical trial NCT05087381: Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community
Official title: Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community With Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide in Decreasing Recovery Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment Efficacy
Keywords: COVID-19
Coronavirus
Treatment
Viral shedding
Coronavirus Infections
Respiratory Tract Infections
Anti-Infective Agents
Fluvoxamine
Bromhexine
Cyproheptadine
Niclosamide
Pneumonia, Viral
Early treatment
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Department of Medical Services Ministry of Public Health of Thailand
name: Ministry of Health, Thailand
name: Mahidol University
name: Ramathibodi Hospital
name: QIMR Berghofer Medical Research Institute
name: Yamagata Prefectural Central Hospital
name: The University of Western Australia
name: Mae Fah Luang University
name: King Chulalongkorn Memorial Hospital
name: Washington University School of Medicine
name: Vibhavadi Hospital
name: Thanyarak Pattani Hospital
First posted: 2021-10-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, multiarm, prospective, randomised controlled trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital admission or mortality related to COVID-19
timeFrame: Within 28 days
measure: Time taken to self- report recovery
timeFrame: Enrolment through final day of participation
measure: Progression to severe COVID-19 Disease
timeFrame: Enrolment through final day of participation
Secondary outcomes:
measure: Reduction (change) in GI viral shedding (by PCR)
timeFrame: Days 0,7,14
measure: Change in respiratory viral clearance (by PCR)
timeFrame: Days 0,7,14
measure: Time to resolution of a fever
timeFrame: Enrolment through final day of participation
measure: Negative effects on well being
timeFrame: Days 0,7,15,28,60
Other outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Enrolment through 30 days after final day of participation
Locations:
city: Ratchathewi
country: Thailand
facility: Rajvithi Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Vibhavadi Hospital
city: Chiangmai
country: Thailand
facility: Chiangmai Neurological Hospital
Study officials:
affiliation: Chulalongkorn University
name: Dhammika Leshan Wannigama, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: QIMR Berghofer Medical Research Institute
name: Cameron Hurst, PhD
role: STUDY_CHAIR
affiliation: Rajvithi Hospital
name: Kanokpoj Chanpiwat, MD
role: STUDY_CHAIR
affiliation: Yamagata Prefectural Central Hospital
name: Shuichi Abe, MD
role: STUDY_CHAIR
affiliation: Ministry of Health, Thailand
name: Katika Akksilp, MD
role: STUDY_DIRECTOR
References: