Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19

NCT ID: NCT06383819

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilisate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection

Detailed Description

The main objective of the clinical study was to prove the superiority of the efficacy of the drug Longidaza® over placebo when used in adult patients with residual changes in the lungs after COVID-19 infection based on the dynamics of respiratory function

Conditions

Post-Acute COVID-19 Syndrome; Lung Disease With Polymyositis; Fibrosis; Lung Diseases, Interstitial; Lung; Disease, Interstitial, With Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Longidaza®

Bovhyaluronidase azoximer, 3000 IU

Group Type: EXPERIMENTAL

Longidaza®

Intervention Type: DRUG

dose 3000 IU intramuscularly once every 5 days, 15 injections

Placebo

The placebo will contain no active pharmaceutical ingredients.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

intramuscularly once every 5 days, 15 injections

Interventions

Longidaza®

dose 3000 IU intramuscularly once every 5 days, 15 injections

Intervention Type: DRUG

Placebo

intramuscularly once every 5 days, 15 injections

Intervention Type: DRUG

Other Intervention Names

Bovhyaluronidase azoximer

Eligibility Criteria

Inclusion Criteria

1. Male and female patients aged 18 to 80 years, who signed an informed consent form.

2. The condition after infection with COVID-19, documented in the period from 1 to 12 months before screening (ICD-10: U07.1, U07.2), including accompanied by hospitalization of the patient.

3. The presence of a negative result of the polymerase chain reaction test (PCR) during screening and an express test for the SARS-CoV-2 antigen at visit 2.

4. The presence of respiratory symptoms (at least dyspnea), while the severity of dyspnea on the mMRC during screening is ≥ 1 point.

5. The value of hemoglobin oxygen saturation: SpO2 < 95% at rest at the screening; and/or desaturation (decrease of SpO2 by ≥ 4% in the 6MWT relative to the value at rest) at the screening.

6. The presence of residual changes in the lung parenchyma characteristic of previous COVID-19 infection, > 10% of the area, according to CT at the screening

7. Respiratory dysfunction of the restrictive type at the screening: FVC < 80%, FVC 1 / FVC > 70%.

Exclusion Criteria

1. A history of chronic respiratory diseases (interstitial lung disease, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, lung cancer).

2. Clinical signs or anamnesis data on the presence of diseases that, according to the researcher, can lead to restrictive changes in respiratory function (pronounced kyphoscoliosis, pleural effusion, neuromuscular diseases), pathological obesity, etc.

3. Clinical signs or anamnesis data on the presence of unstable angina pectoris, stable angina pectoris of high functional class, clinically significant cardiac arrhythmias, chronic heart failure, pulmonary hypertension, suffered pulmonary embolism or acute myocardial infarction in within 6 months prior to screening.

4. Dyspnea of any other etiology: thyrotoxicosis, anemia (hemoglobin less than 100 g/l), pathological obesity (BMI ≥ 40 kg/m2), metabolic acidosis, neuromuscular diseases according to anamnesis or screening examination.

5. The presence of an acute infectious process of any etiology and localization.

6. Allergic reactions to the administration of azoximer bovhyaluronidase or an auxiliary component of the studied drug (mannitol) in the anamnesis.

7. Clinical signs of pulmonary hemorrhage and/or hemoptysis during examination and in the anamnesis.

8. Confirmed eye injuries with vitreous hemorrhage during the last 6 months according to the medical history.

9. Malignant neoplasms of any localization in the anamnesis, with the exception of in situ carcinoma, which required only surgical treatment.

10. Renal failure.

11. Taking drugs of prohibited therapy since the start of screening in this study.

12. Serological test positive for HIV infection, viral hepatitis B and C.

13. Pregnancy or breastfeeding.

14. Participation in clinical trials of an experimental drug within 30 days prior to screening for participation in the current study.

15. Any other medical or social conditions that, in the opinion of the research physician, do not allow the patient to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NPO Petrovax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Avdeev, DM

Role: PRINCIPAL_INVESTIGATOR

I.M. Sechenov First Moscow State Medical University

Locations

State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital"

Aramil, , Russia

Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk"

Chelyabinsk, , Russia

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

Chelyabinsk, , Russia

Alliance Biomedical-Ural Group LLC

Izhevsk, , Russia

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation. The State Autonomous healthcare institution "Hospital for War Veterans of Kazan"

Kazan', , Russia

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation

Kazan', , Russia

State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky"

Kemerovo, , Russia

Medical Center Rhevma-Med LLC

Kemerovo, , Russia

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation

Kirov, , Russia

Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation

Moscow, , Russia

Federal Budgetary Institution of Science "Central Research Institute of Epidemiology" of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being

Moscow, , Russia

Unimed-S Zao

Moscow, , Russia

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

ErSi Medical LLC

Novosibirsk, , Russia

Professorial Clinic LLC

Perm, , Russia

Energia Zdoroviya LLC

Saint Petersburg, , Russia

Medical Center Reavita Med SPb LLC

Saint Petersburg, , Russia

Reavita Med SPb Medical Center LLC

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Eco-Safety Research Center LLC

Saint Petersburg, , Russia

Federal State Budgetary Institution "Consultative and Diagnostic Center with Polyclinic" of the Office of the President of the Russian Federation

Saint Petersburg, , Russia

St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85"

Saint Petersburg, , Russia

Astarta LLC

Saint Petersburg, , Russia

Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation

Saratov, , Russia

Regional State budgetary healthcare institution "Clinical Hospital No. 1"

Smolensk, , Russia

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, , Russia

Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"

Voronezh, , Russia

Medical Center for Diagnosis and Prevention plus LLC

Yaroslavl, , Russia

The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9"

Yaroslavl, , Russia

Ural research Institute of Phthisiopulmonology

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

Long-Cov-III-21

Identifier Type: -

Identifier Source: org_study_id