protocolSection identificationModule nctId: NCT06383819, orgStudyIdInfo 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, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-08, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: NPO Petrovax, class: INDUSTRY, descriptionModule 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, conditionsModule conditions: Post-Acute COVID-19 Syndrome, conditions: Lung Disease With Polymyositis, conditions: Fibrosis, conditions: Lung Diseases, Interstitial, conditions: Lung; Disease, Interstitial, With Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 392, type: ACTUAL, armsInterventionsModule interventions name: Longidaza®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Forced vital capacity (FVC) (visit 4), secondaryOutcomes measure: Slowing the decline in respiratory function, secondaryOutcomes measure: Change in FVC (visit 5), secondaryOutcomes measure: The proportion of patients with an increase in the FVC (%), secondaryOutcomes measure: Dynamics of hemoglobin oxygen saturation (SpO2), secondaryOutcomes measure: The proportion of patients with SpO2 ≥ 93% and < 93%, secondaryOutcomes measure: The proportion of patients with desaturation, secondaryOutcomes measure: The proportion of patients with an increase in the distance of 6MWT, secondaryOutcomes measure: The proportion of patients with a decrease in the severity of dyspnea on the Borg scale, secondaryOutcomes measure: The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC), secondaryOutcomes measure: Change in cough severity on the Visual Analogue Scale (VAS), secondaryOutcomes 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), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital", city: Aramil, zip: 624000, country: Russian Federation, geoPoint lat: 56.6977, lon: 60.8369, locations facility: Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk", city: Chelyabinsk, zip: 454000, country: Russian Federation, geoPoint lat: 55.15402, lon: 61.42915, locations facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3", city: Chelyabinsk, zip: 454021, country: Russian Federation, geoPoint lat: 55.15402, lon: 61.42915, locations facility: Ural research Institute of Phthisiopulmonology, city: Ekaterinburg, zip: 620039, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: Alliance Biomedical-Ural Group LLC, city: Izhevsk, zip: 426061, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations 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, geoPoint lat: 55.78874, lon: 49.12214, locations 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, geoPoint lat: 55.78874, lon: 49.12214, locations facility: State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky", city: Kemerovo, zip: 650000, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: Medical Center Rhevma-Med LLC, city: Kemerovo, zip: 650070, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations 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, geoPoint lat: 58.59665, lon: 49.66007, locations 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, geoPoint lat: 55.75222, lon: 37.61556, locations 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, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Unimed-S Zao, city: Moscow, zip: 119571, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: I.M. Sechenov First Moscow State Medical University, city: Moscow, zip: 119991, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: ErSi Medical LLC, city: Novosibirsk, zip: 630005, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, locations facility: Professorial Clinic LLC, city: Perm, zip: 614070, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Energia Zdoroviya LLC, city: Saint Petersburg, zip: 194156, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Reavita Med SPb LLC, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Reavita Med SPb Medical Center LLC, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"., city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Eco-Safety Research Center LLC, city: Saint Petersburg, zip: 196143, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85", city: Saint Petersburg, zip: 198260, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Astarta LLC, city: Saint Petersburg, zip: 199226, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations 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, geoPoint lat: 51.54056, lon: 46.00861, locations facility: Regional State budgetary healthcare institution "Clinical Hospital No. 1", city: Smolensk, zip: 214006, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations 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, geoPoint lat: 56.49771, lon: 84.97437, locations facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1", city: Voronezh, zip: 394066, country: Russian Federation, geoPoint lat: 51.67204, lon: 39.1843, locations facility: Medical Center for Diagnosis and Prevention plus LLC, city: Yaroslavl, zip: 150040, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, locations facility: The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9", city: Yaroslavl, zip: 150042, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False