A Phase 3 interventional study of Standard therapy recommended by the Ministry of Health of the Russian Federation. and Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection in Acute Respiratory Tract Infection, Acute Respiratory Insufficiency and Pneumonia, sponsored by Burnasyan Federal Medical Biophysical Center. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by Burnasyan Federal Medical Biophysical Center · Phase 3, Interventional, and Treatment
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:
Research objectives are:
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)
6,686 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 320 is above the median of 120 across 4,199 interventional studies indexed under Infections.
Browse Infections studies →Burnasyan Federal Medical Biophysical Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The criteria for early termination of patient participation in the study during the period of use of the study drug are:
80 patients with moderate and critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). Standard therapy is prescribed recommended by the Ministry of Health of the Russian Federation.
Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days).
Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection
80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional inhalation of the drug Leitragin, at a dose of 10 mg daily once a 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 inhalation
80 patients with moderate to critical severity of the disease with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular administration of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days) in conjunction with inhalation of the drug Leitragin, at a dose of 10 mg daily once a 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
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
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
Plan to share: No
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Burnasyan Federal Medical Biophysical Center