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

NCT04346693 | Completed Phase 3

• 1 other identifier: DAL-05-04-2020
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• The change of viral load in patients with SARS-COVID-19.

  Estimated by Polymerase chain reaction (PCR)

  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

  up to 10 days

• Duration of hospitalization

  The number of days a patient is hospitalized

  up to 10 days

• The frequency of early mortality

  Early mortality from all causes will be estimated

  up to 30 days

• The frequency of late mortality

  Late mortality from all causes will be estimated

  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.

  an average of 10 days

Study Arms (4)

group 1

ACTIVE COMPARATOR

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.

group 2

EXPERIMENTAL

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

group 3

EXPERIMENTAL

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

group 4

EXPERIMENTAL

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

Interventions

Standard therapy recommended by the Ministry of Health of the Russian Federation. PROCEDURE

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

group 1

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

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

group 2

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

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.

group 3

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

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

group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Revocation of informed consent by the patient.
• The criteria for early termination of patient participation in the study during the period of use of the study drug are:
• Patient withdrawal of informed consent.
• The occurrence of serious adverse events.
• 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.
• 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.
• The patient receives / needs additional treatment that may affect the outcome of the study or patient safety
• Individual intolerance to research drugs

Sponsors & Collaborators

• Burnasyan Federal Medical Biophysical Center: lead

Study Sites (1)

Burnasyan Federal Medical Biophysical Center FMBA of Russia

Moscow, 123098, Russia

Location

MeSH Terms

Conditions

Pneumonia; Shock, Septic; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: April 8, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 20, 2020
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)