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Post-Acute COVID-19 SyndromePhase 3NCT06383819

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

A Phase 3 study testing Longidaza® in people with Post-Acute COVID-19 Syndrome and Lung Disease With Polymyositis, run by NPO Petrovax at 30 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Longidaza®
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
30 sitesRussia
Study dates
8 Apr 2022to 31 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Russia30 sites

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

    Aramil, 624000

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

    Chelyabinsk, 454000

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

    Chelyabinsk, 454021

  • Alliance Biomedical-Ural Group LLC

    Izhevsk, 426061

  • 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

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

    Kazan', 420012

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

    Kemerovo, 650000

  • Medical Center Rhevma-Med LLC

    Kemerovo, 650070

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

    Kirov, 610027

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

    Moscow, 101990

  • 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

  • Unimed-S Zao

    Moscow, 119571

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991

  • ErSi Medical LLC

    Novosibirsk, 630005

  • Professorial Clinic LLC

    Perm, 614070

  • Energia Zdoroviya LLC

    Saint Petersburg, 194156

  • Medical Center Reavita Med SPb LLC

    Saint Petersburg, 194354

  • Reavita Med SPb Medical Center LLC

    Saint Petersburg, 194354

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

    Saint Petersburg, 194354

  • Eco-Safety Research Center LLC

    Saint Petersburg, 196143

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

    Saint Petersburg, 197110

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

    Saint Petersburg, 198260

  • Astarta LLC

    Saint Petersburg, 199226

  • 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

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

    Smolensk, 214006

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

    Tomsk, 634050

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

    Voronezh, 394066

  • Medical Center for Diagnosis and Prevention plus LLC

    Yaroslavl, 150040

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

    Yaroslavl, 150042

  • Ural research Institute of Phthisiopulmonology

    Yekaterinburg, 620039

Other trials in Russia

About this study

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

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

Read the 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

Being tested
Longidaza®, Placebo
Keywords
Lung Diseases, COVID-19
Medical subject headings
Post-Acute COVID-19 Syndrome, Fibrosis, Lung Diseases, Interstitial, Disease, Lung Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Longidaza®Drug

    Also called Bovhyaluronidase azoximer

    dose 3000 IU intramuscularly once every 5 days, 15 injections

  • PlaceboDrug

    intramuscularly once every 5 days, 15 injections

Study groups in NCT06383819
Study groupRoleWhat they receive
Longidaza®ExperimentalBovhyaluronidase azoximer, 3000 IU
Receives: Drug: Longidaza®
PlaceboPlacebo comparatorThe placebo will contain no active pharmaceutical ingredients.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to Day 71±1

Secondary outcomes (11)

  1. Slowing the decline in respiratory function

    Slowing the decline in respiratory function (FVC (%) compared with the initial data after the end of the observation period

    Measured: Baseline to Day 180±3

  2. Change in FVC (visit 5)

    Change in the FVC (%) compared with the initial data after the end of the observation period

    Measured: Baseline to Day 180±3

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

    The proportion of patients with an increase in the FVC (%) by 10% or more compared to the initial values after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  4. Dynamics of hemoglobin oxygen saturation (SpO2)

    Dynamics of SpO2 values at rest after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  5. The proportion of patients with SpO2 ≥ 93% and < 93%

    The proportion of patients with SpO2 value at rest ≥ 93% and < 93% after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  6. The proportion of patients with desaturation

    The proportion of patients with desaturation, defined as a decrease in SpO2 by ≥ 4% after 6-minute walk test (6MWT) after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  7. The proportion of patients with an increase in the distance of 6MWT

    The proportion of patients with an increase in the distance of 6MWT by 50 m or more after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  8. The proportion of patients with a decrease in the severity of dyspnea on the Borg scale

    The proportion of patients with a decrease in the severity of dyspnea on the Borg scale by ≥ 2 points after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  9. The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC)

    The proportion of patients with a decrease in the severity of dyspnea on the mMRC by ≥ 1 point after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  10. Change in cough severity on the Visual Analogue Scale (VAS)

    Change in cough severity on the VAS after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

  11. Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L)

    Change in the assessment of the quality of life according to the EuroQol-5D-5L after Visit 4 and Visit 5

    Measured: Baseline, Day 71±1, Day 180±3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start8 Apr 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383819
Sponsor's protocol ID
Long-Cov-III-21
Status last verified
May 2025
First submitted
24 Apr 2024
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Avdeev SN, Ignatova GL, Drapkina OM, Popova VB, Melnikova EV, Chudinovskikh TI, Ryabova OV, Egorova NV, Rubanik TV, Shvarts YG, Polyakova SA, Antonova AV, Zubkov DA, Khmelevskii MS, Khomyakova NF, Tsyferov MA, Hardman TC, Tikhonov AA. Bovhyaluronidase azoximer for long-term pulmonary sequelae of COVID19: a multicenter, randomized, double-blind, placebo-controlled study. Expert Rev Respir Med. 2026 Jun 10:1-11. doi: 10.1080/17476348.2026.2684077. Online ahead of print.

    PubMed 42261259

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Longidaza® in people with Post-Acute COVID-19 Syndrome and Lung Disease With Polymyositis, run by NPO Petrovax at 30 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Forced vital capacity (FVC) (visit 4) (time frame: Baseline to Day 71±1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383819, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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