NCT04645368已完成不适用
Multicenter, Open-label Prospective Cohort Study of the Efficacy and Safety of the Inclusion of Longidaze in the Prevention and Treatment of Post-inflammatory Pulmonary Fibrosis and Interstitial Lung Diseases Caused by COVID-19.
NPO Petrovax15 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- The severity of lung tissue lesions with fibrosis and interstitial changes on day 75
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with residual lung changes after complicated COVID-19
- •Residual changes were detected no later than 2 months after the discharge after disease
- •Treatment of COVID-19 was in accordance with the standard of the then current temporary guidelines for the treatment of COVID-19
- •Age of patients over 18 years old
- •Negative polymerase chain reaction (PCR) test COVID-19 at least 2 times in respiratory samples or based on serology results in blood samples
- •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
- •The patient did not participate in other drug clinical trials within 1 month prior to Visit
- •The patient or patient's caregiver agrees to participate in the trial and sign an informed consent form
- •Patient understands and agrees to follow the planned procedures.
- •Women with fertile potential must agree to use at least one method of contraception before completing participation in the study.
排除标准
- •Women during pregnancy and lactation and women planning to become pregnant during the study period
- •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.
- •Long-term bed rest, regardless of its cause
- •Increased individual sensitivity to the components of the studied drug
- •Pathological conditions that determine the impossibility of patient participation in the study (by the decision of the investigator)
- •Medical history that, according to the investigator, does not allow the patient to be included in the study
- •A burdened allergic anamnesis, which, according to the investigator, does not allow the patient to be included in the study
研究组 & 干预措施
Longidaze
80 subjects Longidaze® (bovhyaluronidase azoxymer), lyophilisate for solution for injection
干预措施: bovhyaluronidase azoxymer (Drug)
结局指标
主要结局
The severity of lung tissue lesions with fibrosis and interstitial changes on day 75
时间窗: Day 0, Day 75
The severity of pulmonary tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group according to the results of a blinded central laboratory
次要结局
- Changes in capillary blood oxygen saturation (SpO2)(Day 0, Day 75, Day 180)
- Change in forced vital capacity (FVC)(Day 0, Day 75, Day 180)
- Change in the diffusion capacity of the lungs(Day 0, Day 75, Day 180)
- Changes in the covered footage in the 6-minute walk test(Day 0, Day 75, Day 180)
- The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180(Day 0, Day 180)
- The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180(Day 0, Day 75, Day 180)
- The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) images analyzed by the Botkin.AI program (artificial intelligence)(Day 75, Day 180)
- Change in the degree of dyspnea on the MMRC scale(Day 0, Day 75, Day 180)
- Change in the residual volume of the lungs(Day 0, Day 75)
- Changes in capillary blood saturation (SpO2) after a 6-minute walk test(Day 0, Day 75, Day 180)
- Change in the total lung capacity(Day 0, Day 75)
- Change in inspiratory capacity(Day 75)
研究者
研究点 (15)
Loading locations...
相似试验
Unknown
不适用
Study of the Efficacy and Safety of Longidaze® for the Treatment of Patients With External Genital EndometriosisExternal Genital EndometriosisNCT04962620NPO Petrovax149
已完成
3 期
Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19Post-Acute COVID-19 SyndromeLung Disease With PolymyositisFibrosisLung Diseases, InterstitialDisease, Interstitial, With Fibrosis LungNCT06383819NPO Petrovax392
已完成
不适用
Efficacy and Safety of Longidaze in the Treatment of Lower Urinary Tract Symptoms Associated With Benign Prostatic HyperplasiaLower Urinary Tract SymptomsProstatic HyperplasiaNCT06568718NPO Petrovax229
终止
不适用
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior FixationDegenerative Disc DiseaseNCT02068768LDR Spine USA13
已完成
3 期
Study of PlasmaCap IG in Adults and Children With PIDDPrimary Immune Deficiency Diseases (PIDD)NCT03238079Evolve Biologics63