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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Treatment Efficacy

Treatments: Combination Product: Niclosamide, Bromhexine; Combination Product: Fluvoxamine, Cyproheptadine; Combination Product: Fluvoxamine, Bromhexine; Drug: Niclosamide Pill; Drug: FluvoxaMINE Maleate 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05087381

64197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 6 patient groups

Fluvoxamine Arm

Experimental group

Description:

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.

Treatment:

Drug: FluvoxaMINE Maleate 50 MG

Fluvoxamine in Combination with Bromhexine Arm

Experimental group

Description:

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.

Treatment:

Combination Product: Fluvoxamine, Bromhexine

Fluvoxamine in Combination with Cyproheptadine Arm

Experimental group

Description:

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.

Treatment:

Combination Product: Fluvoxamine, Cyproheptadine

Niclosamide Arm

Experimental group

Description:

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.

Treatment:

Drug: Niclosamide Pill

Niclosamide in Combination with Bromhexine Arm

Experimental group

Description:

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.

Treatment:

Combination Product: Niclosamide, Bromhexine

Usual Care Arm

No Intervention group

Description:

The control group received treatment according to the latest usual care medical guidelines provide by ministry of Thailand at that time.