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

Phase 3

Completed

• Conditions: Septic Shock; Acute Respiratory Tract Infection; Pneumonia; Acute Respiratory Insufficiency; Hypoxemia
• Interventions: 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 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 and Leitragin intramuscular injection

• Registration Number: NCT04346693
• Lead Sponsor: Burnasyan Federal Medical Biophysical Center

Brief 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)

Study Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-15
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
group 1	Standard therapy recommended by the Ministry of Health of the Russian Federation.	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.
group 3	Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation	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.
group 4	Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with 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.
group 2	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 (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).

Primary Outcome Measures

Name	Time	Method
The change of viral load in patients with SARS-COVID-19.	Upon patient inclusion in the study, after 96 hours and on the 10day;	Estimated by Polymerase chain reaction (PCR)
Duration of hospitalization	up to 10 days	The number of days a patient is hospitalized
Clinical status at the time of completion of participation in the study	an average of 10 days	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.
The frequency of development of Acute Respiratory Distress Syndrome (ADRS)	up to 10 days	Assessed through the entire patient participation in the study
The frequency of early mortality	up to 30 days	Early mortality from all causes will be estimated
The frequency of late mortality	up to 90 days	Late mortality from all causes will be estimated

Trial Locations

Locations (1)

Burnasyan Federal Medical Biophysical Center FMBA of Russia; 🇷🇺 Moscow, Russian Federation