A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19
Condition: Pneumonia, Viral; Respiratory Failure
MeSH terms: Pneumonia, Viral; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2/Phase 3

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
    

Intervention name(s): Mefloquine; Hydroxychloroquine; Mefloquine + azithromycin + / - tocilizumab; Hydroxychloroquine + azithromycin + / - tocilizumab
Intervention type(s): Drug; Drug; Combination Product; Combination Product
Intervention description(s): 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.; 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.; 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.; 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.
Intervention MeSH terms: Azithromycin; Hydroxychloroquine; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment