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

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Collaborators: King Chulalongkorn Memorial Hospital; Mae Fah Luang University; Mahidol University; Ministry of Health, Thailand; QIMR Berghofer Medical Research Institute; Rajavithi Hospital; Ramathibodi Hospital; The University of Western Australia; Washington University School of Medicine; Yamagata Prefectural Central Hospital
• Treatments: Bromhexine; Cyproheptadine; Fluvoxamine; Niclosamide

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