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

• Status: Completed
• Trial end date: 2020-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burnasyan Federal Medical Biophysical Center
• Treatments: Azithromycin; Hydroxychloroquine; Mefloquine

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).