Clinical trial NCT04347031: A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pneumonia, Viral
Respiratory Failure
Lead sponsor: Burnasyan Federal Medical Biophysical Center
Sponsor class: OTHER_GOV
First posted: 2020-04-15
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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).

Primary outcomes:
measure: 1st primary endpoint for group 1
timeFrame: up to 10 days
measure: 2nd primary endpoint for group 1
timeFrame: up to 10 days
measure: 1st primary endpoint for group 2
timeFrame: up to 10 days
measure: 2nd primary endpoint for group 2
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: 1st secondary endpoint for group 1
timeFrame: on days 5 and 10
measure: 2nd secondary endpoint for group 1
timeFrame: on day 10
measure: 3d secondary endpoint for group 1
timeFrame: up to 10 days
measure: 4th secondary endpoint for group 1
timeFrame: up to 10 days
measure: 5th secondary endpoint for group 1
timeFrame: up to 10 days
measure: 6th secondary endpoint for group 1
timeFrame: up to 10 days
measure: 1st secondary endpoint for group 2
timeFrame: on days 5 and 10
measure: 2nd secondary endpoint for group 2
timeFrame: up to 10 days
measure: 3d secondary endpoint for group 2
timeFrame: up to 10 days
measure: 4th secondary endpoint for group 2
timeFrame: up to 10 days
measure: 5th secondary endpoint for group 2
timeFrame: up to 10 days
measure: 6th secondary endpoint for group 2
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Burnasyan Federal Medical Biophysical Center FMBA of Russia
Study officials:
affiliation: Burnasyan FMBC SRC FMBA of Russia
name: Tatiana Astrelina, MD PhD,DSc.
role: PRINCIPAL_INVESTIGATOR
References: