Efficacy of Mefloquine as Prophylaxis Against COVID-19: A Placebo-control, Randomized Clinical Trial
Status:
Recruiting
Trial end date:
2021-08-30
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Helwan University
Collaborators:
Ain Shams University Assiut University Fayoum University National Institute of Infectious Diseases, Tokyo, Japan Tanta University