Efficacy of Mefloquine as Prophylaxis Against COVID-19: A Placebo-control, Randomized Clinical Trial

• Status: Recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy and safety of Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed. This study is an open-label, randomized, placebo controlled trial.

A total of 1500 household contacts of COVID-19 confirmed cases who will attend triaging clinic of 5 Egyptian university centers (Helwan university hospital, Ain Shams university hospital, Assiut University Hospital, Fayoum university hospital and Tanta university hospital). The household contacts of COVID-19 confirmed subjects with a decision for home-isolation will be recruited to participate into this study. The recruited subjects from each center will be randomly assigned (locally in that center) into 2 groups (750 volunteer in each group). The 1st group will receive Mefloquine (1100-1650 mg according to body weight), orally, while the other group will receive the same number of placebo tablets (control group). Previous infection will be excluded for all recruited subjects by testing for the presence of anti-bodies against COVID-19 to exclude previous infection. Subjects who are tested negative will be allocated into one of the 2 study groups after randomization, and treatment will be started immediately (either mefloquine or placebo). In addition, a nasopharyngeal swap will be taken from each recruited subject and tested by PCR for COVID-19 to exclude current infection. After having the PCR results, positive cases will be analyzed separately to test for the disease severity.

Neurological and cardiac assessment will be done for all volunteers before recruitment to exclude the presence of any contraindication for Mefloquine intake. Both groups will be followed up clinically to detect any symptom or sign of COVID-19 infection for 2 weeks (during the period of home isolation). Nasopharyngeal swap with PCR for COVID-19 will be done for all included subjects at the end of the follow-up period (14 days), or at the appearance of symptoms or signs suggesting COVID-19 infection.

Primary end points of the study are either:

• End of follow up period (2 weeks)

• Confirmed diagnosis of COVID-19 infection during the study time Initial severity assessment of COVID-19 infection will be done in all infected subjects in both groups to compare severity, in addition to following up of the fate of the infected subjects.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helwan University
• Collaborators: Ain Shams University; Assiut University; Fayoum University; National Institute of Infectious Diseases, Tokyo, Japan; Tanta University
• Treatments: Mefloquine

Criteria

Inclusion Criteria:

• This study will include volunteers household contact of COVID 19 confirmed cases who attend the triage clinic in the participating centers. Included persons should be > 18 years old and below 65 years, without any contraindications for Mefloquine usage.

Exclusion Criteria:

• • People with history of previous confirmed COVID-19 infection.

• Pregnant and lactating females.

• People with neuropsychiatric disorders: myasthenia gravis, epilepsy, psychotic disorder, schizophrenia, repeated episodes of anxiety, depression.

• People with liver cirrhosis or raised liver enzymes.

• People with arrhythmias or prolonged QT interval on EKG.

• People with a history of Quinidine-Quinine analogs allergy.