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Study of Longidaze in the Prevention & Treatment of Pulmonary Fibrosis, Interstitial Lung Diseases Caused by COVID-19

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04645368
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NPO Petrovax
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibroses, Pulmonary

Additional Details

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.

Arms & Interventions

Arms

: Longidaze

80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection

: Dynamic control

80 subjects Patients not receiving active therapy

Interventions

Drug: - bovhyaluronidase azoxymer

3000 IU intramuscularly once every 5 days with a course of 15 injections

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Astrakhan, Astrakhan Region, Russian Federation

Status

Recruiting

Address

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

Astrakhan, Astrakhan Region, 414000

Site Contact

T. R. Kasyanova