nctId: NCT06383819 id: Long-Cov-III-21 briefTitle: Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19 overallStatus: COMPLETED date: 2022-04-08 date: 2023-12-31 date: 2023-12-31 date: 2024-04-25 date: 2024-04-25 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilizate 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 conditions: Post-Acute COVID-19 Syndrome conditions: Lung Disease With Polymyositis conditions: Fibrosis conditions: Lung Diseases, Interstitial conditions: Lung; Disease, Interstitial, With Fibrosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 392 type: ACTUAL name: Longidaza® name: Placebo measure: Change in Forced vital capacity (FVC) (visit 4) measure: Slowing the decline in respiratory function measure: Change in FVC (visit 5) measure: The proportion of patients with an increase in the FVC (%) measure: Dynamics of hemoglobin oxygen saturation (SpO2) measure: The proportion of patients with SpO2 ≥ 93% and < 93% measure: The proportion of patients with desaturation measure: The proportion of patients with an increase in the distance of 6MWT measure: The proportion of patients with a decrease in the severity of dyspnea on the Borg scale measure: The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC) measure: Change in cough severity on the Visual Analogue Scale (VAS) measure: Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital" city: Aramil zip: 624000 country: Russian Federation lat: 56.6977 lon: 60.8369 facility: Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk" city: Chelyabinsk zip: 454000 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3" city: Chelyabinsk zip: 454021 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: Ural research Institute of Phthisiopulmonology city: Ekaterinburg zip: 620039 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Alliance Biomedical-Ural Group LLC city: Izhevsk zip: 426061 country: Russian Federation lat: 56.84976 lon: 53.20448 facility: 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" city: Kazan zip: 420012 country: Russian Federation lat: 55.78874 lon: 49.12214 facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation city: Kazan zip: 420012 country: Russian Federation lat: 55.78874 lon: 49.12214 facility: State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky" city: Kemerovo zip: 650000 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: Medical Center Rhevma-Med LLC city: Kemerovo zip: 650070 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation city: Kirov zip: 610027 country: Russian Federation lat: 58.59665 lon: 49.66007 facility: Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation city: Moscow zip: 101990 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal Budgetary Institution of Science "Central Research Institute of Epidemiology" of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being city: Moscow zip: 111123 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Unimed-S Zao city: Moscow zip: 119571 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow zip: 119991 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: ErSi Medical LLC city: Novosibirsk zip: 630005 country: Russian Federation lat: 55.0415 lon: 82.9346 facility: Professorial Clinic LLC city: Perm zip: 614070 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Energia Zdoroviya LLC city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Reavita Med SPb LLC city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Reavita Med SPb Medical Center LLC city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1". city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Eco-Safety Research Center LLC city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State Budgetary Institution "Consultative and Diagnostic Center with Polyclinic" of the Office of the President of the Russian Federation city: Saint Petersburg zip: 197110 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85" city: Saint Petersburg zip: 198260 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Astarta LLC city: Saint Petersburg zip: 199226 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation city: Saratov zip: 410012 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Regional State budgetary healthcare institution "Clinical Hospital No. 1" city: Smolensk zip: 214006 country: Russian Federation lat: 54.7818 lon: 32.0401 facility: Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation city: Tomsk zip: 634050 country: Russian Federation lat: 56.49771 lon: 84.97437 facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1" city: Voronezh zip: 394066 country: Russian Federation lat: 51.67204 lon: 39.1843 facility: Medical Center for Diagnosis and Prevention plus LLC city: Yaroslavl zip: 150040 country: Russian Federation lat: 57.62987 lon: 39.87368 facility: The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9" city: Yaroslavl zip: 150042 country: Russian Federation lat: 57.62987 lon: 39.87368 hasResults: False