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

PHASE3CompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

November 1, 2020

Study Completion Date

November 20, 2020

Conditions
Acute Respiratory Tract InfectionAcute Respiratory InsufficiencyPneumoniaSeptic ShockHypoxemia
Interventions
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"

Trial Locations (1)

123098

Burnasyan Federal Medical Biophysical Center FMBA of Russia, Moscow

All Listed Sponsors
lead

Burnasyan Federal Medical Biophysical Center

OTHER_GOV

NCT04346693 - An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19 | Biotech Hunter | Biotech Hunter