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Study of Longidaze in the Prevention & Treatment of Pulmonary Fibrosis, Interstitial Lung Diseases Caused by COVID-19

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ClinicalTrials.gov Identifier: NCT04645368
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
NPO Petrovax

Brief Summary:
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.

Condition or disease Intervention/treatment
Fibroses, Pulmonary Drug: bovhyaluronidase azoxymer

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Open-label Prospective Cohort Study of the Efficacy and Safety of the Inclusion of Longidaze in the Prevention and Treatment of Post-inflammatory Pulmonary Fibrosis and Interstitial Lung Diseases Caused by COVID-19.
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Group/Cohort Intervention/treatment
Longidaze
80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection
Drug: bovhyaluronidase azoxymer
3000 IU intramuscularly once every 5 days with a course of 15 injections
Other Name: Longidaze

Dynamic control
80 subjects Patients not receiving active therapy



Primary Outcome Measures :
  1. The severity of lung tissue lesions with fibrosis and interstitial changes on day 75 [ Time Frame: Day 0, 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


Secondary Outcome Measures :
  1. The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180 [ Time Frame: Day 0, 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)

  2. The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180 [ Time Frame: Day 0, Day 75, 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)

  3. 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) [ Time Frame: Day 75, Day 180 ]
    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

  4. Change in forced vital capacity (FVC) [ Time Frame: Day 0, Day 75, Day 180 ]
    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

  5. Change in the diffusion capacity of the lungs [ Time Frame: Day 0, Day 75, Day 180 ]
    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

  6. Change in the degree of dyspnea on the MMRC scale [ Time Frame: Day 0, Day 75, Day 180 ]

    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

    1. - mild - Shortness of breath bothers with brisk walking or climbing a small elevation
    2. - moderate to severe - Shortness of breath results in slower walking compared to other people of the same age, or need to stop while walking at normal pace on a level surface
    3. - Severe - Shortness of breath makes you stop when walking about 100 m or after a few minutes of walking on a flat surface
    4. - very severe - Shortness of breath makes it impossible to leave the house or appears when dressing and undressing

  7. Changes in capillary blood oxygen saturation (SpO2) [ Time Frame: Day 0, Day 75, Day 180 ]
    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.

  8. Changes in the covered footage in the 6-minute walk test [ Time Frame: Day 0, Day 75, Day 180 ]
    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.

  9. Changes in capillary blood saturation (SpO2) after a 6-minute walk test [ Time Frame: Day 0, Day 75, Day 180 ]
    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.

  10. Change in the residual volume of the lungs [ Time Frame: Day 0, Day 75 ]
    Change in the residual volume of the lungs after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.

  11. Change in the total lung capacity [ Time Frame: Day 0, Day 75 ]
    Change in the total lung capacity after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.

  12. Change in inspiratory capacity [ Time Frame: Day 75 ]
    Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  1. Patients with residual lung changes after complicated COVID-19
  2. Residual changes were detected no later than 2 months after the discharge after disease
  3. Treatment of COVID-19 was in accordance with the standard of the then current temporary guidelines for the treatment of COVID-19
  4. Age of patients over 18 years old
  5. Negative polymerase chain reaction (PCR) test COVID-19 at least 2 times in respiratory samples or based on serology results in blood samples
  6. Patients in the framework of routine clinical practice, in accordance with the instructions for use before inclusion in the study, were prescribed intramuscular treatment with Longidaze® at a dose of 3000 IU, 1 injection every 5 days for a total course of 15 injections or dynamic observation without the use of active therapy
  7. The patient did not participate in other drug clinical trials within 1 month prior to Visit 1.
  8. The patient or patient's caregiver agrees to participate in the trial and sign an informed consent form
  9. Patient understands and agrees to follow the planned procedures.
  10. Women with fertile potential must agree to use at least one method of contraception before completing participation in the study.

Exclusion Criteria:

  1. Women during pregnancy and lactation and women planning to become pregnant during the study period
  2. Severe background diseases, such as severe heart failure (class IV heart function), severe liver and kidney disease, severe bronchial asthma, severe chronic obstructive pulmonary disease, bronchiectasis, bullous emphysema and previously identified interstitial lung diseases, neurological diseases, tumors.
  3. Long-term bed rest, regardless of its cause
  4. Increased individual sensitivity to the components of the studied drug
  5. Pathological conditions that determine the impossibility of patient participation in the study (by the decision of the investigator)
  6. Medical history that, according to the investigator, does not allow the patient to be included in the study
  7. A burdened allergic anamnesis, which, according to the investigator, does not allow the patient to be included in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645368


Contacts
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Contact: Nikolay S. Dodonov +7(495) 730-75-45 ext 125 DodonovNS@petrovax.ru

Locations
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Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Astrakhan State Medical University" of the Ministry of Health of the Russian Federation Recruiting
Astrakhan, Astrakhan Region, Russian Federation, 414000
Contact: T. R. Kasyanova         
Municipal autonomous health care institution "City Clinical Polyclinic No. 8" Recruiting
Chelyabinsk, Chelyabinsk Region, Russian Federation, 454007
Contact: U. V. Argamakova         
State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3" Recruiting
Chelyabinsk, Chelyabinsk Region, Russian Federation, 454021
Contact: G. L. Ignatova         
Municipal budgetary institution "Central city clinical hospital number 6 " Recruiting
Ekaterinburg, Ekaterinburg Region, Russian Federation, 620149
Contact: A. U. Petuhova         
Medical center "Clinic South" Recruiting
Krasnodar, Krasnodar Region, Russian Federation, 350042
Contact: N. V. Kotova         
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 Recruiting
Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660022
Contact: A. G. Borisov         
Institute of Clinical Immunology LLC Recruiting
Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660133
Contact: A. G. Borisov         
St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1" Recruiting
Saint Petersburg, Leningrad Region, Russian Federation, 194354
Contact: T. V. Rubanik         
State Novosibirsk Regional Clinical Hospital Recruiting
Novosibirsk, Novosibirsk Region, Russian Federation, 630087
Contact: L. M. Kudelya         
CJSC "Medical Center" Philosophy of Beauty and Health " Recruiting
Perm, Perm Region, Russian Federation, 614107
Contact: O. V. Masalkina         
State budgetary institution of health care Republican clinical hospital named after G.G. Kuvatova Recruiting
Ufa, Ufa Region, Russian Federation, 450005
Contact: O. A. Shagabutdinova         
State health care institution "Clinical Hospital No. 4" Recruiting
Volgograd, Volgograd Region, Russian Federation, 400065
Contact: V. V. Naumov         
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 Recruiting
Volgograd, Volgograd Region, Russian Federation, 400131
Contact: O. A. Chernyavskaya         
FSBI "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation Recruiting
Moscow, Russian Federation, 105229
Contact: A. A. Zaycev         
State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 180 of the Department of Healthcare of the City of Moscow" Recruiting
Moscow, Russian Federation, 125222
Contact: L. I. Korneva         
Sponsors and Collaborators
NPO Petrovax
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Responsible Party: NPO Petrovax
ClinicalTrials.gov Identifier: NCT04645368    
Other Study ID Numbers: DISSOLVE
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Fibrosis
Pathologic Processes
Respiratory Tract Diseases