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.
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
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
st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
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
st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.
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).
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russian Federation
Tatiana Astrelina, MD PhD,DSc., Principal Investigator
Burnasyan FMBC SRC FMBA of Russia