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

NCT04847661 | Completed Phase 2 DMC

• 1 other identifier: 032
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• The efficacy of Mefloquine

  will be measured by the detection of the difference in the rate of COVID-19 infection in both groups from the time of randomization

  2 weeks from randomization

• Severity of COVID-19

  for those infected during the study period

  2 weeks from randomization

Study Arms (2)

Mefloquine arm

ACTIVE COMPARATOR

Mefloquine hydrochloride will be given in a dose of 1100-1650 mg, according to body weight (BW), splitted into two to three doses. * 30kg≤BW\<45kg: 825mg followed by 275mg after 6-8 hours * 45kg≤BW\<60kg: 825mg followed by 550mg after 6-8 hours * 60kg≤BW: 825mg followed by 550mg after 6-8 hours and then 275mg 6-8 hours after the second dose

Drug: Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases

Control arm

PLACEBO COMPARATOR

A similar tablet of non-active gradients was specifically manufactured for the study by EVA Pharma company. The placebo tablets exactly resemble the active treatment mefloquine tablets (the same shape, size and color).

Drug: Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases

Interventions

Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases DRUG

Mefloquine hydrochloride will be given in a dose of 1100-1650 mg, according to body weight (BW), splitted into two to three doses.

Control arm; Mefloquine arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead
• Ain Shams University: collaborator
• Fayoum University: collaborator
• Assiut University: collaborator
• Tanta University: collaborator
• National Institute of Infectious Diseases, Tokyo, Japan: collaborator

Study Sites (1)

Helwan University

Cairo, 11795, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Mefloquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be assigned randomly (locally in each center) in a 1:1 ratio to receive either Mefloquine (1100-1650 mg according to body weight), orally, or to receive the same number of placebo tablets (control group).Patients will be sequentially assigned a randomization number that was generated by an independent statistician. Randomization sequence will be provided in pre-sealed envelopes by the central co-ordination committee of the study. Individuals involved in randomization and masking will have no involvement in the rest of the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and chief of Endemic Medicine Department

Model Details: open-label, randomized, placebo controlled trial

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: March 28, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

EG (1)