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

Burnasyan Federal Medical Biophysical Center

Status and phase: Completed; Phase 3

Conditions: Acute Respiratory Insufficiency; Pneumonia; Hypoxemia; Septic Shock; Acute Respiratory Tract Infection

Treatments: Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation; Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation; Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.; Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04346693

DAL-05-04-2020

Details and patient eligibility

About

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.

Full 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)

Enrollment: 320 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

group 1

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.

group 2

Experimental group

Description:

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).

Treatment:

Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection

group 3

Experimental group

Description:

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.

Treatment:

Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation

group 4

Experimental group

Description:

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.

Treatment:

Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation