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

NCT04645368 | Completed

• 1 other identifier: DISSOLVE
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 15

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.

Conditions

Fibroses, Pulmonary

Outcome Measures

Primary Outcomes (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

  Day 0, Day 75

Secondary Outcomes (12)

• The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180

  Day 0, Day 180

• The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180

  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)

  Day 75, Day 180

• Change in forced vital capacity (FVC)

  Day 0, Day 75, Day 180

• Change in the diffusion capacity of the lungs

  Day 0, Day 75, Day 180

Study Arms (2)

Longidaze

80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection

Drug: bovhyaluronidase azoxymer

Dynamic control

80 subjects Patients not receiving active therapy

Interventions

bovhyaluronidase azoxymer DRUG

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

Also known as: Longidaze

Longidaze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (15)

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

Location

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

Chelyabinsk, Chelyabinsk Oblast, 454007, Russia

Location

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

Chelyabinsk, Chelyabinsk Oblast, 454021, Russia

Location

Municipal budgetary institution "Central city clinical hospital number 6 "

Yekaterinburg, Ekaterinburg Region, 620149, Russia

Location

Medical center "Clinic South"

Krasnodar, Krasnodarskiy Kray, 350042, Russia

Location

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

Location

Institute of Clinical Immunology LLC

Krasnoyarsk, Krasnoyarsk Region, 660133, Russia

Location

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

Saint Petersburg, Leningradskaya Oblast', 194354, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Novosibirsk Oblast, 630087, Russia

Location

CJSC "Medical Center" Philosophy of Beauty and Health "

Perm, Perm Krai, 614107, Russia

Location

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

Ufa, Ufa Region, 450005, Russia

Location

State health care institution "Clinical Hospital No. 4"

Volgograd, Volgograd Oblast, 400065, Russia

Location

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

Location

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

Moscow, 105229, Russia

Location

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

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: July 1, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)