Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the new SARS-CoV-2 coronavirus (COVID-19)

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.

• Registration Number: EUCTR2020-001194-69-ES
• Lead Sponsor: Félix Gutiérrez Rodero

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

People in close contact with adults diagnosed with COVID-19 who sign the informed consent. Close contact is defined as those who live at home with an infected person, who have had intimate relationships or whose job is less than two meters from the infected person.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Patients <18 years.
-Patients with symptoms suggestive of SARS-CoV-2 infection.
-Women who are pregnant or who intend to become pregnant for the next three months after taking the drug.
-Patients allergic to mefloquine or other quinine or quinidine-type medications.
-Patients with a neurological history (seizures, epilepsy, etc.).
-Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt).
-Patients with cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study.
-Patients in treatment with other medications such as valproic acid, antiarrhythmics, antihistamines H1, beta-blockers, calcium channel blockers, chloroquine, halofantrine, phenothiazines, quinidine and quinine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified