Clinical trial NCT04645368: Study of Longidaze in the Prevention & Treatment of Pulmonary Fibrosis, Interstitial Lung Diseases Caused by COVID-19
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroses, Pulmonary
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: The severity of lung tissue lesions with fibrosis and interstitial changes on day 75
timeFrame: Day 0, Day 75
Secondary outcomes:
measure: The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180
timeFrame: Day 0, Day 180
measure: The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180
timeFrame: Day 0, Day 75, Day 180
measure: 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)
timeFrame: Day 75, Day 180
measure: Change in forced vital capacity (FVC)
timeFrame: Day 0, Day 75, Day 180
measure: Change in the diffusion capacity of the lungs
timeFrame: Day 0, Day 75, Day 180
measure: Change in the degree of dyspnea on the MMRC scale
timeFrame: Day 0, Day 75, Day 180
measure: Changes in capillary blood oxygen saturation (SpO2)
timeFrame: Day 0, Day 75, Day 180
measure: Changes in the covered footage in the 6-minute walk test
timeFrame: Day 0, Day 75, Day 180
measure: Changes in capillary blood saturation (SpO2) after a 6-minute walk test
timeFrame: Day 0, Day 75, Day 180
measure: Change in the residual volume of the lungs
timeFrame: Day 0, Day 75
measure: Change in the total lung capacity
timeFrame: Day 0, Day 75
measure: Change in inspiratory capacity
timeFrame: Day 75
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Astrakhan State Medical University" of the Ministry of Health of the Russian Federation
state: Astrakhan Region
city: Chelyabinsk
country: Russian Federation
facility: Municipal autonomous health care institution "City Clinical Polyclinic No. 8"
state: Chelyabinsk Region
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3"
state: Chelyabinsk Region
city: Ekaterinburg
country: Russian Federation
facility: Municipal budgetary institution "Central city clinical hospital number 6 "
state: Ekaterinburg Region
city: Krasnodar
country: Russian Federation
facility: Medical center "Clinic South"
state: Krasnodar Region
city: Krasnoyarsk
country: Russian Federation
facility: 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
state: Krasnoyarsk Region
city: Krasnoyarsk
country: Russian Federation
facility: Institute of Clinical Immunology LLC
state: Krasnoyarsk Region
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"
state: Leningrad Region
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
state: Novosibirsk Region
city: Perm
country: Russian Federation
facility: CJSC "Medical Center" Philosophy of Beauty and Health "
state: Perm Region
city: Ufa
country: Russian Federation
facility: State budgetary institution of health care Republican clinical hospital named after G.G. Kuvatova
state: Ufa Region
city: Volgograd
country: Russian Federation
facility: State health care institution "Clinical Hospital No. 4"
state: Volgograd Region
city: Volgograd
country: Russian Federation
facility: 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
state: Volgograd Region
city: Moscow
country: Russian Federation
facility: FSBI "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 180 of the Department of Healthcare of the City of Moscow"
Study officials:
References: