The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilisate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection
The main objective of the clinical study was to prove the superiority of the efficacy of the drug Longidaza® over placebo when used in adult patients with residual changes in the lungs after COVID-19 infection based on the dynamics of respiratory function
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
392
dose 3000 IU intramuscularly once every 5 days, 15 injections
intramuscularly once every 5 days, 15 injections
Change in Forced vital capacity (FVC) (visit 4)
Change in the FVC (%) compared with the initial data according to spirometry data after completion of the course of therapy
Time frame: Baseline to Day 71±1
Slowing the decline in respiratory function
Slowing the decline in respiratory function (FVC (%) compared with the initial data after the end of the observation period
Time frame: Baseline to Day 180±3
Change in FVC (visit 5)
Change in the FVC (%) compared with the initial data after the end of the observation period
Time frame: Baseline to Day 180±3
The proportion of patients with an increase in the FVC (%)
The proportion of patients with an increase in the FVC (%) by 10% or more compared to the initial values after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
Dynamics of hemoglobin oxygen saturation (SpO2)
Dynamics of SpO2 values at rest after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
The proportion of patients with SpO2 ≥ 93% and < 93%
The proportion of patients with SpO2 value at rest ≥ 93% and \< 93% after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
The proportion of patients with desaturation
The proportion of patients with desaturation, defined as a decrease in SpO2 by ≥ 4% after 6-minute walk test (6MWT) after Visit 4 and Visit 5
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State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital"
Aramil, Russia
Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk"
Chelyabinsk, Russia
State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3"
Chelyabinsk, Russia
Alliance Biomedical-Ural Group LLC
Izhevsk, Russia
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation. The State Autonomous healthcare institution "Hospital for War Veterans of Kazan"
Kazan', Russia
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
Kazan', Russia
State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky"
Kemerovo, Russia
Medical Center Rhevma-Med LLC
Kemerovo, Russia
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation
Kirov, Russia
Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation
Moscow, Russia
...and 20 more locations
Time frame: Baseline, Day 71±1, Day 180±3
The proportion of patients with an increase in the distance of 6MWT
The proportion of patients with an increase in the distance of 6MWT by 50 m or more after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
The proportion of patients with a decrease in the severity of dyspnea on the Borg scale
The proportion of patients with a decrease in the severity of dyspnea on the Borg scale by ≥ 2 points after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC)
The proportion of patients with a decrease in the severity of dyspnea on the mMRC by ≥ 1 point after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
Change in cough severity on the Visual Analogue Scale (VAS)
Change in cough severity on the VAS after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3
Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L)
Change in the assessment of the quality of life according to the EuroQol-5D-5L after Visit 4 and Visit 5
Time frame: Baseline, Day 71±1, Day 180±3