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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
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
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russia
The change of viral load in patients with SARS-COVID-19.
Estimated by Polymerase chain reaction (PCR)
Time frame: Upon patient inclusion in the study, after 96 hours and on the 10day;
The frequency of development of Acute Respiratory Distress Syndrome (ADRS)
Assessed through the entire patient participation in the study
Time frame: up to 10 days
Duration of hospitalization
The number of days a patient is hospitalized
Time frame: up to 10 days
The frequency of early mortality
Early mortality from all causes will be estimated
Time frame: up to 30 days
The frequency of late mortality
Late mortality from all causes will be estimated
Time frame: up to 90 days
Clinical status at the time of completion of participation in the study
Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: 1. Death; 2. Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; 3. Hospitalization extended, on non-invasive ventilation; 4. Hospitalization is extended, needs additional oxygen; 5. Hospitalization is extended, additional oxygen is not required; 6. Discharged.
Time frame: an average of 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.