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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347031
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Tatyana Astrelina, Burnasyan Federal Medical Biophysical Center

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE April 8, 2020
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 1st primary endpoint for group 1 [ Time Frame: up to 10 days ]
    The number of patients with development of respiratory failure requiring transfer to the ICU.
  • 2nd primary endpoint for group 1 [ Time Frame: up to 10 days ]
    The period of clinical recovery.
  • 1st primary endpoint for group 2 [ Time Frame: up to 10 days ]
    The period of clinical recovery.
  • 2nd primary endpoint for group 2 [ Time Frame: through study completion, an average of 3 months ]
    Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • 1st primary endpoint for group 1 [ Time Frame: up to 3 months ]
    The number of patients with development of respiratory failure requiring transfer to the ICU.
  • 2nd primary endpoint for group 1 [ Time Frame: through study completion, an average of 3 months ]
    The period of clinical recovery.
  • 1st primary endpoint for group 2 [ Time Frame: through study completion, an average of 3 months ]
    The period of clinical recovery.
  • 2nd primary endpoint for group 2 [ Time Frame: through study completion, an average of 3 months ]
    Frequency of fatal outcomes associated with coronavirus infection disease (COVID19)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 1st secondary endpoint for group 1 [ Time Frame: on days 5 and 10 ]
    A change in viral load by conducting PCR assay through different timeframes
  • 2nd secondary endpoint for group 1 [ Time Frame: on day 10 ]
    Frequency of clinical cure on day 10 from the start of therapy
  • 3d secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    The retention time of the reaction temperature from the start of the treatment.
  • 4th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Concentration of C-reactive protein in blood plasma.
  • 5th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Respiratory index.
  • 6th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Frequency appearance unwanted phenomena and serious unwanted phenomena
  • 1st secondary endpoint for group 2 [ Time Frame: on days 5 and 10 ]
    A change in viral load by conducting PCR assay through different timeframes
  • 2nd secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Respiratory index.
  • 3d secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    The retention time of the reaction temperature from the start of treatment.
  • 4th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Concentration of C-reactive protein in blood plasma.
  • 5th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Number of patients required transition to alternative therapy schedule
  • 6th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Frequency of adverse events and serious adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • 1st secondary endpoint for group 1 [ Time Frame: on days 5, 10 and 90 ]
    A change in viral load by conducting PCR assay through different timeframes
  • 2nd secondary endpoint for group 1 [ Time Frame: on day 10 ]
    Frequency of clinical recovery on day 10 from the start of therapy
  • 3d secondary endpoint for group 1 [ Time Frame: up to 3 months ]
    The retention time of the reaction temperature from the start of treatment.
  • 4th secondary endpoint for group 1 [ Time Frame: up to 3 months ]
    Concentration of C-reactive protein in blood plasma.
  • 5th secondary endpoint for group 1 [ Time Frame: up to 3 months ]
    Respiratory index.
  • 6th secondary endpoint for group 1 [ Time Frame: through study completion, an average of 3 months ]
    Frequency of adverse events and serious adverse events
  • 1st secondary endpoint for group 2 [ Time Frame: on days 5, 10 and 90 ]
    A change in viral load by conducting PCR assay through different timeframes
  • 2nd secondary endpoint for group 2 [ Time Frame: up to 3 months ]
    Respiratory index.
  • 3d secondary endpoint for group 2 [ Time Frame: up to 3 months ]
    The retention time of the reaction temperature from the start of treatment.
  • 4th secondary endpoint for group 2 [ Time Frame: up to 3 months ]
    Concentration of C-reactive protein in blood plasma.
  • 5th secondary endpoint for group 2 [ Time Frame: through study completion, an average of 3 months ]
    Number of patients required transition to alternative therapy schedule
  • 6th secondary endpoint for group 2 [ Time Frame: through study completion, an average of 3 months ]
    Frequency of adverse events and serious adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19
Official Title  ICMJE An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19
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.
Detailed Description

Purpose of the study:

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.

Study aims:

  1. To study the efficacy of the drug Mefloquine, tablet 250 mg, for the treatment of patients with coronavirus infection (light and medium-heavy form), the appointment in the "off-label" in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label".
  2. To study the effectiveness of the drug Mefloquine, tablet 250 mg, when administered in the mode "off label", in comparison with the drug Hydroxychloroquine tablets 200 mg, when administered in the mode "off label" when applied to a schema for the treatment of patients with severe coronavirus infection.
  3. Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (mild and moderate-severe forms).
  4. Evaluate the safety and tolerability of Mefloquine, 250 mg tablets, and Hydroxychloroquine, 200 mg tablets, for the treatment of patients with coronavirus infection (severe forms), when used as part of a regimen for the treatment of patients with severe coronavirus infection.

Study design:

An open, randomized, multicenter comparative study of the efficacy and safety of Mefloquine and Hydroxychloroquine in "off-label" mode for the treatment of patients with COVID-19 coronavirus infection

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pneumonia, Viral
  • Respiratory Failure
Intervention  ICMJE
  • Drug: Mefloquine

    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: Hydroxychloroquine
    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.
  • Combination Product: Mefloquine + azithromycin + / - tocilizumab

    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.
  • Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab
    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.
Study Arms  ICMJE
  • Experimental: group 1 cohort 1

    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.
    Intervention: Drug: Mefloquine
  • Experimental: group 1 cohort 2

    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.

    Intervention: Drug: Hydroxychloroquine
  • Experimental: group 2 cohort 1
    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.
    Intervention: Combination Product: Mefloquine + azithromycin + / - tocilizumab
  • Experimental: group 2 cohort 2
    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.
    Intervention: Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
320
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2020
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The criteria for retiring a volunteer during the screening period are:

    1. Revoking informed consent of patients.
    2. Non-compliance of the volunteer with the inclusion criteria.
    3. First identified the condition and/or disease described in the criteria for inclusion.
    4. 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:

  1. Withdrawal of informed consent by a volunteer.
  2. First identified the condition and/or disease described in the criteria for inclusion.
  3. Occurrence of serious adverse events.
  4. 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.
  5. The need for patients included in the study, antibiotics of the fluoroquinolone group.
  6. 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.
  7. the Patient receives / needs additional treatment that may affect the outcome of the study or the patient's safety
  8. Individual intolerance to research drugs
  9. Erroneous inclusion (for example, the patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04347031
Other Study ID Numbers  ICMJE FL-01/20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tatyana Astrelina, Burnasyan Federal Medical Biophysical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Burnasyan Federal Medical Biophysical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tatiana Astrelina, MD PhD,DSc. Burnasyan FMBC SRC FMBA of Russia
PRS Account Burnasyan Federal Medical Biophysical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP