Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

Early Phase 1

• Conditions: Hydroxychloroquine; Antimalarials; Enzyme Inhibitors; Antirheumatic Agents
• Interventions: Drug: Hydroxychloroquine Sulfate; Drug: Bromhexine 8 MG

• Registration Number: NCT04340349
• Lead Sponsor: Instituto Nacional de Rehabilitacion

Brief Summary

This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine and Bromhexine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.

Detailed Description

This study will combine two drugs (hydroxychloroquine and Bromhexine) to see if hydroxychloroquine is better in combination with Bromhexine in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City. Hydroxychloroquine will be used in a low dose (200 mg every 24 hrs). Bromhexine will be 8mg every 8 hrs. The study groups will be the following: 1) HCQ 200mg/d + BHH placebo 2) HCQ placebo plus BHH placebo

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-09
• Study Start: 2021-02-01
• Primary Completion: 2021-05-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-26
• Last Update Posted: 2021-06-29
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Hydroxychloroquine plus Bromhexine	Hydroxychloroquine Sulfate	200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Experimental: Hydroxychloroquine plus Bromhexine	Bromhexine 8 MG	200 mg of Hydroxychloroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Hydroxychloroquine plus Bromhexine	Hydroxychloroquine Sulfate	200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months
Hydroxychloroquine plus Bromhexine	Bromhexine 8 MG	200 mg of Hydroxycholoroquine daily for 2 months 8 mg of Bromhexine every 8 hrs for 2 months

Primary Outcome Measures

Name	Time	Method
Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2	Day 60	Primary endpoint will be the proportion of health personnel infected by SARS-CoV-2 at day 60 after starting treatment, in both groups. The infection will be diagnosed using qRT-PCR for relative expression of the mRNA of SARS-CoV-2 and the measure of IgM and IgG antibodies anti-SARS-CoV-2 after day 7 of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM

Secondary Outcome Measures

Name	Time	Method
Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2	Day 90	The secondary endpoint will be the proportion of health personnel infected 90 days after starting treatment in both groups. The infection will be diagnosed using qRT-PCR for relative expression of the mRNA of SARS-CoV-2 and the measure of IgM and IgG antibodies anti-SARS-CoV-2 after day 7 of the start of treatment using rapid test Cellex qSARS-CoV-2 IgG/IgM

Trial Locations

Locations (1)

National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra; 🇲🇽 Mexico City, Cdmx, Mexico