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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 : Active, not recruiting
First Posted : April 15, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Tatyana Astrelina, Burnasyan Federal Medical Biophysical Center

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Respiratory Failure Drug: Mefloquine Drug: Hydroxychloroquine Combination Product: Mefloquine + azithromycin + / - tocilizumab Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
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.
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.

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.

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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 2nd primary endpoint for group 1 [ Time Frame: up to 10 days ]
    The period of clinical recovery.

  3. 1st primary endpoint for group 2 [ Time Frame: up to 10 days ]
    The period of clinical recovery.

  4. 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)


Secondary Outcome Measures :
  1. 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

  2. 2nd secondary endpoint for group 1 [ Time Frame: on day 10 ]
    Frequency of clinical cure on day 10 from the start of therapy

  3. 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.

  4. 4th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Concentration of C-reactive protein in blood plasma.

  5. 5th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Respiratory index.

  6. 6th secondary endpoint for group 1 [ Time Frame: up to 10 days ]
    Frequency appearance unwanted phenomena and serious unwanted phenomena

  7. 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

  8. 2nd secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Respiratory index.

  9. 3d secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    The retention time of the reaction temperature from the start of treatment.

  10. 4th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Concentration of C-reactive protein in blood plasma.

  11. 5th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Number of patients required transition to alternative therapy schedule

  12. 6th secondary endpoint for group 2 [ Time Frame: up to 10 days ]
    Frequency of adverse events and serious adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347031


Locations
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Russian Federation
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russian Federation, 123098
Sponsors and Collaborators
Burnasyan Federal Medical Biophysical Center
Investigators
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Principal Investigator: Tatiana Astrelina, MD PhD,DSc. Burnasyan FMBC SRC FMBA of Russia
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Responsible Party: Tatyana Astrelina, MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia, Burnasyan Federal Medical Biophysical Center
ClinicalTrials.gov Identifier: NCT04347031    
Other Study ID Numbers: FL-01/20
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Virus Diseases
Azithromycin
Hydroxychloroquine
Mefloquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents