An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19
Condition: Acute Respiratory Tract Infection; Acute Respiratory Insufficiency; Pneumonia; Septic Shock; Hypoxemia
MeSH terms: Infections; Respiratory Tract Infections; Respiratory Insufficiency; Hypoxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate an effectiveness of the drug Dalargin in combination
      with Leitragin for the prevention and treatment of severe pulmonary complications symptoms
      associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as
      Severe acute respiratory syndrome Cоrona Virus Disease 2019 ).

      Test drugs that will be administered to patients are:

        -  Leitragin, solution for inhalation administration,

        -  Dalargin, solution for intravenous and intramuscular administration.
    

Detailed description: 
      Research objectives are:

        1. To study the effectiveness of the drug Leitragin, a solution for inhalation, for the
           prevention of severe pulmonary complications in patients with coronavirus infection
           (SARS-COVID-19);

        2. To study the effectiveness of the drug Leitragin, a solution for inhalation, for the
           treatment of severe pulmonary complications in patients with coronavirus infection
           (SARS-COVID-19);

        3. To study the effectiveness of the drug Dalargin, a solution for intravenous and
           intramuscular administration, for the prevention of severe pulmonary complications in
           patients with coronavirus infection (SARS-COVID-19);

        4. To study the effectiveness of the drug Dalargin, a solution for intravenous and
           intramuscular administration, for the treatment of severe pulmonary complications in
           patients with coronavirus infection (SARS-COVID-19);

        5. To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for
           inhalation administration, for the prevention of severe pulmonary complications in
           patients with coronavirus infection (SARS-COVID-19);

        6. To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for
           inhalation administration, for the treatment of severe pulmonary complications in
           patients with coronavirus infection (SARS-COVID-19);

        7. To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for
           intravenous and intramuscular administration, for the prevention of severe pulmonary
           complications in patients with coronavirus infection (SARS-COVID-19);

        8. To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for
           intravenous and intramuscular administration, for the treatment of severe pulmonary
           complications in patients with coronavirus infection (SARS-COVID-19).

      Upon admission to a specialized hospital for all patients with suspected COVID-19 Polymerase
      chain reaction (PCR) is being conducted. Only patients with confirmed coronavirus infection
      are included in the study.

      It is an open, randomized clinical trial of the drug Dalargin in combination with Leitragin
      for the prevention and treatment of severe pulmonary complications symptoms in patients with
      coronavirus infection (SARS-COVID-19)
    

Intervention name(s): Standard therapy recommended by the Ministry of Health of the Russian Federation.; Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection; Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation; Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days; Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days; Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.; Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.
Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment