Clinical trial NCT06383819: Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Acute COVID-19 Syndrome
Lung Disease With Polymyositis
Fibrosis
Lung Diseases, Interstitial
Lung; Disease, Interstitial, With Fibrosis
Keywords: Lung Diseases
COVID-19
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Forced vital capacity (FVC) (visit 4)
timeFrame: Baseline to Day 71±1
Secondary outcomes:
measure: Slowing the decline in respiratory function
timeFrame: Baseline to Day 180±3
measure: Change in FVC (visit 5)
timeFrame: Baseline to Day 180±3
measure: The proportion of patients with an increase in the FVC (%)
timeFrame: Baseline, Day 71±1, Day 180±3
measure: Dynamics of hemoglobin oxygen saturation (SpO2)
timeFrame: Baseline, Day 71±1, Day 180±3
measure: The proportion of patients with SpO2 ≥ 93% and < 93%
timeFrame: Baseline, Day 71±1, Day 180±3
measure: The proportion of patients with desaturation
timeFrame: Baseline, Day 71±1, Day 180±3
measure: The proportion of patients with an increase in the distance of 6MWT
timeFrame: Baseline, Day 71±1, Day 180±3
measure: The proportion of patients with a decrease in the severity of dyspnea on the Borg scale
timeFrame: Baseline, Day 71±1, Day 180±3
measure: The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Baseline, Day 71±1, Day 180±3
measure: Change in cough severity on the Visual Analogue Scale (VAS)
timeFrame: Baseline, Day 71±1, Day 180±3
measure: Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L)
timeFrame: Baseline, Day 71±1, Day 180±3
Other outcomes:
Locations:
city: Aramil
country: Russian Federation
facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital"
city: Chelyabinsk
country: Russian Federation
facility: Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk"
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3"
city: Ekaterinburg
country: Russian Federation
facility: Ural research Institute of Phthisiopulmonology
city: Izhevsk
country: Russian Federation
facility: Alliance Biomedical-Ural Group LLC
city: Kazan
country: Russian Federation
facility: 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"
city: Kazan
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation
city: Kemerovo
country: Russian Federation
facility: State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky"
city: Kemerovo
country: Russian Federation
facility: Medical Center Rhevma-Med LLC
city: Kirov
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal Budgetary Institution of Science "Central Research Institute of Epidemiology" of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being
city: Moscow
country: Russian Federation
facility: Unimed-S Zao
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Novosibirsk
country: Russian Federation
facility: ErSi Medical LLC
city: Perm
country: Russian Federation
facility: Professorial Clinic LLC
city: Saint Petersburg
country: Russian Federation
facility: Energia Zdoroviya LLC
city: Saint Petersburg
country: Russian Federation
facility: Medical Center Reavita Med SPb LLC
city: Saint Petersburg
country: Russian Federation
facility: Reavita Med SPb Medical Center LLC
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1".
city: Saint Petersburg
country: Russian Federation
facility: Eco-Safety Research Center LLC
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "Consultative and Diagnostic Center with Polyclinic" of the Office of the President of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85"
city: Saint Petersburg
country: Russian Federation
facility: Astarta LLC
city: Saratov
country: Russian Federation
facility: 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
city: Smolensk
country: Russian Federation
facility: Regional State budgetary healthcare institution "Clinical Hospital No. 1"
city: Tomsk
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
city: Voronezh
country: Russian Federation
facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1"
city: Yaroslavl
country: Russian Federation
facility: Medical Center for Diagnosis and Prevention plus LLC
city: Yaroslavl
country: Russian Federation
facility: The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9"
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Sergey Avdeev, DM
role: PRINCIPAL_INVESTIGATOR
References: