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

NCT06383819 | Completed Phase 3 DMC

• 1 other identifier: Long-Cov-III-21
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 30

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

Conditions

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

Keywords

Lung Diseases; COVID-19

Outcome Measures

Primary Outcomes (1)

• Change in Forced vital capacity (FVC) (visit 4)

  Change in the FVC (%) compared with the initial data according to spirometry data after completion of the course of therapy

  Baseline to Day 71±1

Secondary Outcomes (11)

• Slowing the decline in respiratory function

  Baseline to Day 180±3

• Change in FVC (visit 5)

  Baseline to Day 180±3

• The proportion of patients with an increase in the FVC (%)

  Baseline, Day 71±1, Day 180±3

• Dynamics of hemoglobin oxygen saturation (SpO2)

  Baseline, Day 71±1, Day 180±3

• The proportion of patients with SpO2 ≥ 93% and < 93%

  Baseline, Day 71±1, Day 180±3

Study Arms (2)

Longidaza®

EXPERIMENTAL

Bovhyaluronidase azoximer, 3000 IU

Drug: Longidaza®

Placebo

PLACEBO COMPARATOR

The placebo will contain no active pharmaceutical ingredients.

Drug: Placebo

Interventions

Longidaza® DRUG

dose 3000 IU intramuscularly once every 5 days, 15 injections

Also known as: Bovhyaluronidase azoximer

Longidaza®

Placebo DRUG

intramuscularly once every 5 days, 15 injections

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 to 80 years, who signed an informed consent form.
• 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.
• 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.
• The presence of respiratory symptoms (at least dyspnea), while the severity of dyspnea on the mMRC during screening is ≥ 1 point.
• 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.
• 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
• Respiratory dysfunction of the restrictive type at the screening: FVC \< 80%, FVC 1 / FVC \> 70%.

You may not qualify if:

• A history of chronic respiratory diseases (interstitial lung disease, chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, lung cancer).
• 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.
• 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.
• 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.
• The presence of an acute infectious process of any etiology and localization.
• Allergic reactions to the administration of azoximer bovhyaluronidase or an auxiliary component of the studied drug (mannitol) in the anamnesis.
• Clinical signs of pulmonary hemorrhage and/or hemoptysis during examination and in the anamnesis.
• Confirmed eye injuries with vitreous hemorrhage during the last 6 months according to the medical history.
• Malignant neoplasms of any localization in the anamnesis, with the exception of in situ carcinoma, which required only surgical treatment.
• Renal failure.
• Taking drugs of prohibited therapy since the start of screening in this study.
• Serological test positive for HIV infection, viral hepatitis B and C.
• Pregnancy or breastfeeding.
• Participation in clinical trials of an experimental drug within 30 days prior to screening for participation in the current study.
• Any other medical or social conditions that, in the opinion of the research physician, do not allow the patient to participate in this study.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (30)

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

Aramil, 624000, Russia

Location

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

Chelyabinsk, 454000, Russia

Location

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

Chelyabinsk, 454021, Russia

Location

Alliance Biomedical-Ural Group LLC

Izhevsk, 426061, Russia

Location

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', 420012, Russia

Location

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

Kazan', 420012, Russia

Location

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

Kemerovo, 650000, Russia

Location

Medical Center Rhevma-Med LLC

Kemerovo, 650070, Russia

Location

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

Kirov, 610027, Russia

Location

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

Moscow, 101990, Russia

Location

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, 111123, Russia

Location

Unimed-S Zao

Moscow, 119571, Russia

Location

I.M. Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

ErSi Medical LLC

Novosibirsk, 630005, Russia

Location

Professorial Clinic LLC

Perm, 614070, Russia

Location

Energia Zdoroviya LLC

Saint Petersburg, 194156, Russia

Location

Medical Center Reavita Med SPb LLC

Saint Petersburg, 194354, Russia

Location

Reavita Med SPb Medical Center LLC

Saint Petersburg, 194354, Russia

Location

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

Saint Petersburg, 194354, Russia

Location

Eco-Safety Research Center LLC

Saint Petersburg, 196143, Russia

Location

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

Saint Petersburg, 197110, Russia

Location

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

Saint Petersburg, 198260, Russia

Location

Astarta LLC

Saint Petersburg, 199226, Russia

Location

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, 410012, Russia

Location

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

Smolensk, 214006, Russia

Location

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

Tomsk, 634050, Russia

Location

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

Voronezh, 394066, Russia

Location

Medical Center for Diagnosis and Prevention plus LLC

Yaroslavl, 150040, Russia

Location

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

Yaroslavl, 150042, Russia

Location

Ural research Institute of Phthisiopulmonology

Yekaterinburg, 620039, Russia

Location

MeSH Terms

Conditions

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

Interventions

Longidaza

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey Avdeev, DM

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 25, 2024
• Study Start: April 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (30)