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)

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001194-69-ES

Enrollment

200

Registered

2020-04-07

Start date

2020-03-30

Completion date

Unknown

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

Trade Name: Lariam Pharmaceutical Form: Capsule, hard INN or Proposed INN: MEFLOQUINE CAS Number: 53230-10-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Ph

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the protective efficacy of mefloquine prophylaxis against placebo in close contacts of people with COVID-19.;Secondary Objective: -Establish if the preventive administration of mefloquine attenuates the clinical manifestations of COVID-19 in people who become infected. -Evaluate the safety of prophylactic mefloquine in this setting.;Primary end point(s): COVID-19 infection.;Timepoint(s) of evaluation of this end point: The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection.	—

Measure

Time frame

Main Objective: To determine the protective efficacy of mefloquine prophylaxis against placebo in close contacts of people with COVID-19.;Secondary Objective: -Establish if the preventive administration of mefloquine attenuates the clinical manifestations of COVID-19 in people who become infected. -Evaluate the safety of prophylactic mefloquine in this setting.;Primary end point(s): COVID-19 infection.;Timepoint(s) of evaluation of this end point: The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection.

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Secondary

Measure	Time frame
Secondary end point(s): Mortality, gravity of COVID-19 infection;Timepoint(s) of evaluation of this end point: The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection and effects	—

Countries

Spain

Contacts

Public ContactUnidad de Enfermedades Infecciosas

FISABIO

gutierrez_fel@gva.es34966616234

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026