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An Open Randomized Study of Dalargin Effectiveness in Patients With Severe and Critical Manifestations of SARS-COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346693
Recruitment Status : Active, not recruiting
First Posted : April 15, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Tatyana Astrelina, Burnasyan Federal Medical Biophysical Center

Brief Summary:

The purpose of the study is to evaluate an effectiveness of the drug Dalargin 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 drug that will be administered to patients are:

  • Dalargin, solution for inhalation administration,
  • Dalargin, solution for intravenous and intramuscular administration.

Condition or disease Intervention/treatment Phase
Acute Respiratory Tract Infection Acute Respiratory Insufficiency Pneumonia Septic Shock Hypoxemia 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 Dalargin intramuscular injection Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Phase 3

Detailed Description:

Research objectives are:

  1. To study the effectiveness of the drug Dalargin, 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 Dalargin, 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 Dalargin, 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 Dalargin, 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 efficacy for the prevention and treatment of severe pulmonary complications symptoms in patients with coronavirus infection (SARS-COVID-19)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group 1
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.

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


Experimental: group 2
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 Dalargin 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


Experimental: group 3
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 Dalargin, 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 Dalargin 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 Dalargin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.


Experimental: group 4
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 Dalargin, 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 Dalargin intramuscular injection combined with Dalargin 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 Dalargin, 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





Primary Outcome Measures :
  1. The change of viral load in patients with SARS-COVID-19. [ Time Frame: Upon patient inclusion in the study, after 96 hours and on the 10day; ]
    Estimated by Polymerase chain reaction (PCR)

  2. The frequency of development of Acute Respiratory Distress Syndrome (ADRS) [ Time Frame: up to 10 days ]
    Assessed through the entire patient participation in the study

  3. Duration of hospitalization [ Time Frame: up to 10 days ]
    The number of days a patient is hospitalized

  4. The frequency of early mortality [ Time Frame: up to 30 days ]
    Early mortality from all causes will be estimated

  5. The frequency of late mortality [ Time Frame: up to 90 days ]
    Late mortality from all causes will be estimated

  6. Clinical status at the time of completion of participation in the study [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346693


Locations
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Russian Federation
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russian Federation, 123098
Sponsors and Collaborators
Burnasyan Federal Medical Biophysical Center
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Responsible Party: Tatyana Astrelina, MD PhD, DSc (medicine), Head of Center for Biomedical Technologies State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia, Burnasyan Federal Medical Biophysical Center
ClinicalTrials.gov Identifier: NCT04346693    
Other Study ID Numbers: DAL-05-04-2020
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Pneumonia
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
enkephalin-Leu, Ala(2)-Arg(6)-
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action