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)
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
Inclusion Criteria:
- Patients from the age of 18 years male and female;
- Coronavirus infection confirmed by results of Polymerase chain reaction test;
- Hospitalization of the patient;
- The presence of a signed informed consent to participate in the study.
Exclusion Criteria:
1. Revocation of informed consent by the patient.
2. Patient mismatch inclusion criteria.
3. First identified conditions and / or diseases described in the non-inclusion criteria.
The criteria for early termination of patient participation in the study during the period
of use of the study drug are:
1. Patient withdrawal of informed consent.
2. First identified conditions and / or diseases described in the non-inclusion criteria.
3. The occurrence of serious adverse events.
4. Adverse events that do not meet the criteria of severity, the development of which,
according to the researcher, further participation in the study may be detrimental to
the health or well-being of the patient.
5. Administrative reasons (termination of the study by the Sponsor or regulatory
authorities), as well as gross protocol violations that may affect the results of the
study.
6. The patient receives / needs additional treatment that may affect the outcome of the
study or patient safety
7. Individual intolerance to research drugs
8. Incorrect inclusion (for example, the patient was included in violation of the
criteria for inclusion / non-inclusion of the protocol)
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russian Federation