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Fibroses, PulmonaryNCT04645368

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

An observational study of Fibroses, Pulmonary, run by NPO Petrovax at 15 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibroses, Pulmonary
What is being tested?
bovhyaluronidase azoxymer
Type of treatment
Injection or infusion
How many people
160 participants
Where
15 sitesRussia
Study dates
1 Jul 2020to 20 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patients with residual lung changes after complicated COVID-19
  • Residual changes were detected no later than 2 months after the discharge after disease
  • Treatment of COVID-19 was in accordance with the standard of the then current temporary guidelines for the treatment of COVID-19
  • Age of patients over 18 years old
  • Negative polymerase chain reaction (PCR) test COVID-19 at least 2 times in respiratory samples or based on serology results in blood samples
  • 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
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  • The patient did not participate in other drug clinical trials within 1 month prior to Visit 1.
  • The patient or patient's caregiver agrees to participate in the trial and sign an informed consent form
  • Patient understands and agrees to follow the planned procedures.
  • Women with fertile potential must agree to use at least one method of contraception before completing participation in the study.

Who cannot join

  • Women during pregnancy and lactation and women planning to become pregnant during the study period
  • 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.
  • Long-term bed rest, regardless of its cause
  • Increased individual sensitivity to the components of the studied drug
  • Pathological conditions that determine the impossibility of patient participation in the study (by the decision of the investigator)
  • Medical history that, according to the investigator, does not allow the patient to be included in the study
  • A burdened allergic anamnesis, which, according to the investigator, does not allow the patient to be included in the study

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Russia15 sites

  • 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

  • Municipal autonomous health care institution "City Clinical Polyclinic No. 8"

    Chelyabinsk, Chelyabinsk Oblast, 454007

  • State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3"

    Chelyabinsk, Chelyabinsk Oblast, 454021

  • Medical center "Clinic South"

    Krasnodar, Krasnodarskiy Kray, 350042

  • 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

  • Institute of Clinical Immunology LLC

    Krasnoyarsk, Krasnoyarsk Region, 660133

  • FSBI "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation

    Moscow, 105229

  • 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

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, Novosibirsk Oblast, 630087

  • CJSC "Medical Center" Philosophy of Beauty and Health "

    Perm, Perm Krai, 614107

  • St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"

    Saint Petersburg, Leningradskaya Oblast', 194354

  • State budgetary institution of health care Republican clinical hospital named after G.G. Kuvatova

    Ufa, Ufa Region, 450005

  • State health care institution "Clinical Hospital No. 4"

    Volgograd, Volgograd Oblast, 400065

  • 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

  • Municipal budgetary institution "Central city clinical hospital number 6 "

    Yekaterinburg, Ekaterinburg Region, 620149

Other trials in Russia

About this study

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.

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.

Read the 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.

Being tested
bovhyaluronidase azoxymer
Medical subject headings
Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bovhyaluronidase azoxymerDrug

    Also called Longidaze

    3000 IU intramuscularly once every 5 days with a course of 15 injections

Study groups in NCT04645368
Study groupRoleWhat they receive
Longidaze80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection
Receives: Drug: bovhyaluronidase azoxymer
Dynamic control80 subjects Patients not receiving active therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 0, Day 75

Secondary outcomes (12)

  1. 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)

    Measured: Day 0, Day 180

  2. 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)

    Measured: Day 0, Day 75, Day 180

  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)

    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

    Measured: Day 75, Day 180

  4. 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

    Measured: Day 0, Day 75, Day 180

  5. 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

    Measured: Day 0, Day 75, Day 180

  6. 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

    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

    Measured: Day 0, Day 75, Day 180

  7. 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.

    Measured: Day 0, Day 75, Day 180

  8. 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.

    Measured: Day 0, Day 75, Day 180

  9. 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.

    Measured: Day 0, Day 75, Day 180

  10. 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.

    Measured: Day 0, Day 75

  11. 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.

    Measured: Day 0, Day 75

  12. Change in inspiratory capacity

    Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group

    Measured: Day 75

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start1 Jul 2020
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04645368
Sponsor's protocol ID
DISSOLVE
Status last verified
Apr 2024
First submitted
20 Nov 2020
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibroses, Pulmonary, run by NPO Petrovax at 15 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of lung tissue lesions with fibrosis and interstitial changes on day 75 (time frame: Day 0, Day 75). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04645368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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