Status:
COMPLETED
An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19
Lead Sponsor:
Burnasyan Federal Medical Biophysical Center
Conditions:
Acute Respiratory Tract Infection
Acute Respiratory Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
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 (S...
Eligibility Criteria
Inclusion
- 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
- Revocation of informed consent by the patient.
- Patient mismatch inclusion criteria.
- 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:
- Patient withdrawal of informed consent.
- First identified conditions and / or diseases described in the non-inclusion criteria.
- 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
- Incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04346693
Start Date
April 8 2020
End Date
November 20 2020
Last Update
October 13 2021
Active Locations (1)
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1
Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russia, 123098