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.
Trial ID: NCT04645368
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2020-07-01
Completion date: 2022-04-20
Sponsor: NPO Petrovax
Conditions: Fibroses, Pulmonary
Interventions: bovhyaluronidase azoxymer
Locations: Federal State Budgetary Educational Institution of Higher Education "Astrakhan State Medical University" of the Ministry of Health of the Russian Federation; Municipal autonomous health care institution "City Clinical Polyclinic No. 8"; State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3"; Municipal budgetary institution "Central city clinical hospital number 6 "; Medical center "Clinic South"; 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; Institute of Clinical Immunology LLC; St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"; State Novosibirsk Regional Clinical Hospital; CJSC "Medical Center" Philosophy of Beauty and Health "; State budgetary institution of health care Republican clinical hospital named after G.G. Kuvatova; State health care institution "Clinical Hospital No. 4"; 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; FSBI "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation; State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 180 of the Department of Healthcare of the City of Moscow"
Countries: Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia; Russia
Enrollment: 160
Age range: 18 Years - None
Sex: ALL

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.

Eligibility 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

Outcomes:
The severity of lung tissue lesions with fibrosis and interstitial changes on day 75