A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19

NCT04347031 | Completed Phase 2

• 1 other identifier: FL-01/20
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

Conditions

Pneumonia, Viral; Respiratory Failure

Outcome Measures

Primary Outcomes (4)

• 1st primary endpoint for group 1

  The number of patients with development of respiratory failure requiring transfer to the ICU.

  up to 10 days

• 2nd primary endpoint for group 1

  The period of clinical recovery.

  up to 10 days

• 1st primary endpoint for group 2

  The period of clinical recovery.

  up to 10 days

• 2nd primary endpoint for group 2

  Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)

  through study completion, an average of 3 months

Secondary Outcomes (12)

• 1st secondary endpoint for group 1

  on days 5 and 10

• 2nd secondary endpoint for group 1

  on day 10

• 3d secondary endpoint for group 1

  up to 10 days

• 4th secondary endpoint for group 1

  up to 10 days

• 5th secondary endpoint for group 1

  up to 10 days

Study Arms (4)

group 1 cohort 1

EXPERIMENTAL

80 patients who receive Mefloquine prescribed according to the following scheme: * 1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.

Drug: Mefloquine

group 1 cohort 2

EXPERIMENTAL

80 patients who receive Hydroxychloroquine prescribed according to the following scheme: • 1st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

Drug: Hydroxychloroquine

group 2 cohort 1

EXPERIMENTAL

A concomitant therapy consisting of Mefloquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Mefloquine is same as for group 1 cohort 1.

Combination Product: Mefloquine + azithromycin + / - tocilizumab

group 2 cohort 2

EXPERIMENTAL

A concomitant therapy consisting of Hydroxychloroquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Hydroxychloroquine is same as for group 1 cohort 2.

Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab

Interventions

Mefloquine DRUG

1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.

group 1 cohort 1

Hydroxychloroquine DRUG

1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

group 1 cohort 2

Mefloquine + azithromycin + / - tocilizumab COMBINATION_PRODUCT

1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours. * Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours. * 3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.

group 2 cohort 1

Hydroxychloroquine + azithromycin + / - tocilizumab COMBINATION_PRODUCT

1. st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2. nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

group 2 cohort 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged 18 years and older COVID19 positive confirmed by PCR, without ARDS and sepsis.
• Hospitalization of the patient.
• Signed informed consent for participation in the study.

You may not qualify if:

• The criteria for retiring a volunteer during the screening period are:
• Revoking informed consent of patients.
• Positive test for HIV infection, Hepatitis B, C, syphilis.
• The criteria for early termination of participation of volunteers in the study during the period of use of the study drug are:
• Withdrawal of informed consent by a volunteer.
• Occurrence of serious adverse events.
• Adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be harmful to the health or well-being of the volunteer.
• The need for patients included in the study, antibiotics of the fluoroquinolone group.
• Administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as gross violations of the Protocol that may affect the results of the study.
• the Patient receives / needs additional treatment that may affect the outcome of the study or the patient's safety
• Individual intolerance to research drugs

Sponsors & Collaborators

• Burnasyan Federal Medical Biophysical Center: lead

Study Sites (1)

Burnasyan Federal Medical Biophysical Center FMBA of Russia

Moscow, 123098, Russia

Location

MeSH Terms

Conditions

Pneumonia, Viral; Respiratory Insufficiency

Interventions

Mefloquine; Hydroxychloroquine; Azithromycin; tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chloroquine; Aminoquinolines; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Tatiana Astrelina, MD PhD,DSc.

  Burnasyan FMBC SRC FMBA of Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 15, 2020
• Study Start: April 8, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 20, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

RU (1)