NCT04346693

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Burnasyan Federal Medical Biophysical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Respiratory Tract Infection
• Acute Respiratory Insufficiency
• Pneumonia
• Septic Shock
• Hypoxemia

Interventions

Type	Name	Description
PROCEDURE	Standard therapy recommended by the Ministry of Health of the Russian Federation.	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
PROCEDURE	Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection	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
PROCEDURE	Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation	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.
PROCEDURE	Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation	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

Timeline

• Start date: 2020-04-08
• Primary completion: 2020-11-01
• Completion: 2020-11-20
• First posted: 2020-04-15
• Last updated: 2021-10-13

Locations

1 site across 1 country: Russia