Clinical trial NCT04346693: An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19
Official title: An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Tract Infection
Acute Respiratory Insufficiency
Pneumonia
Septic Shock
Hypoxemia
Lead sponsor: Burnasyan Federal Medical Biophysical Center
Sponsor class: OTHER_GOV
First posted: 2020-04-15
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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)

Eligibility 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)

Primary outcomes:
measure: The change of viral load in patients with SARS-COVID-19.
timeFrame: Upon patient inclusion in the study, after 96 hours and on the 10day;
measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)
timeFrame: up to 10 days
measure: Duration of hospitalization
timeFrame: up to 10 days
measure: The frequency of early mortality
timeFrame: up to 30 days
measure: The frequency of late mortality
timeFrame: up to 90 days
measure: Clinical status at the time of completion of participation in the study
timeFrame: an average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Burnasyan Federal Medical Biophysical Center FMBA of Russia
Study officials:
References: