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A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease following COVID-19.
The aim of the study is to compare the outcomes associated with postinflammatory pulmonary fibrosis and interstitial lung disease among a cohort of adult patients after complicated pulmonary manifestations of COVID-19 in two groups: in a group of patients who were prescribed Longidaze® for treatment or prevention as part of routine clinical practice, and in the group of patients who underwent dynamic observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longidaze | 80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection |
| |
| Dynamic control | 80 subjects Patients not receiving active therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bovhyaluronidase azoxymer | Drug | 3000 IU intramuscularly once every 5 days with a course of 15 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| The severity of lung tissue lesions with fibrosis and interstitial changes on day 75 | The severity of pulmonary tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group according to the results of a blinded central laboratory | Day 0, Day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180 | The severity of lung tissue damage by fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 6 months in relation to the baseline values of the indicator in patients of the Longidaze® group in comparison with the the dynamic observation group (according to the results of a blinded central laboratory) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients (over 18 years old) with residual changes in the lungs against the background of the transferred COVID-19, who were prescribed Longidaze®, lyophilisate for solution for injection, 3000 IU or underwent dynamic observation without the use of active therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Educational Institution of Higher Education "Astrakhan State Medical University" of the Ministry of Health of the Russian Federation | Astrakhan | Astrakhan Oblast | 414000 | Russia |
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| Day 0, Day 180 |
| The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180 | The severity of lung tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group (according to the results of the local laboratory) | Day 0, Day 75, Day 180 |
| The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) images analyzed by the Botkin.AI program (artificial intelligence) | The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) based on the high-resolution computed tomography images analyzed by the Botkin.AI program (artificial intelligence) and then verified by a specialist after 2.5 months and 6 months from the beginning of observation in relation to the baseline values of indicators in patients of the Longidaze® group in comparison with the dynamic observation group | Day 75, Day 180 |
| Change in forced vital capacity (FVC) | Change in forced vital capacity FVC (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group | Day 0, Day 75, Day 180 |
| Change in the diffusion capacity of the lungs | Change in the diffusion capacity of the lungs (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group | Day 0, Day 75, Day 180 |
| Change in the degree of dyspnea on the MMRC scale | Change in the degree of dyspnea on the MMRC scale from baseline after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. MMRC scale (Modified Medical Research Council scale) 0 - no - Dyspnea does not bother, except for very intense exercise
| Day 0, Day 75, Day 180 |
| Changes in capillary blood oxygen saturation (SpO2) | Changes in SpO2 of capillary blood relative to the initial value after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. | Day 0, Day 75, Day 180 |
| Changes in the covered footage in the 6-minute walk test | Changes in the covered footage in the 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. | Day 0, Day 75, Day 180 |
| Changes in capillary blood saturation (SpO2) after a 6-minute walk test | Changes in capillary blood saturation (SpO2) after a 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. | Day 0, Day 75, Day 180 |
| Change in the residual volume of the lungs | Change in the residual volume of the lungs after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group. | Day 0, Day 75 |
| Change in the total lung capacity | Change in the total lung capacity after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group. | Day 0, Day 75 |
| Change in inspiratory capacity | Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group | Day 75 |
| Municipal autonomous health care institution "City Clinical Polyclinic No. 8" | Chelyabinsk | Chelyabinsk Oblast | 454007 | Russia |
| State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3" | Chelyabinsk | Chelyabinsk Oblast | 454021 | Russia |
| Municipal budgetary institution "Central city clinical hospital number 6 " | Yekaterinburg | Ekaterinburg Region | 620149 | Russia |
| Medical center "Clinic South" | Krasnodar | Krasnodarskiy Kray | 350042 | Russia |
| Federal State Budgetary Scientific Institution "Federal Research Center" Krasnoyarsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences " Scientific Research Institute of Medical Problems of the North | Krasnoyarsk | Krasnoyarsk Region | 660022 | Russia |
| Institute of Clinical Immunology LLC | Krasnoyarsk | Krasnoyarsk Region | 660133 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1" | Saint Petersburg | Leningradskaya Oblast' | 194354 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | Novosibirsk Oblast | 630087 | Russia |
| CJSC "Medical Center" Philosophy of Beauty and Health " | Perm | Perm Krai | 614107 | Russia |
| State budgetary institution of health care Republican clinical hospital named after G.G. Kuvatova | Ufa | Ufa Region | 450005 | Russia |
| State health care institution "Clinical Hospital No. 4" | Volgograd | Volgograd Oblast | 400065 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation Volgograd State Medical University of the Ministry of Health of Russia | Volgograd | Volgograd Oblast | 400131 | Russia |
| FSBI "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation | Moscow | 105229 | Russia |
| State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 180 of the Department of Healthcare of the City of Moscow" | Moscow | 125222 | Russia |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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