Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Frequency of serious adverse events (SAE) related to the administration of the IMP
研究概览
简要总结
Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen.
MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.
详细描述
The MONACO Cell Therapy Study is a prospective, non-randomised, open label study phase I/II clinical trial with a key objective of evaluating safety of MON002 in 5 adults who have a clinical diagnosis of interstitial lung disease (pulmonary fibrosis) after recovery from acute COVID-19 infection. The main objectives of this study are to: (1) to determine the safety profile of MON002 by assessing clinical responses in adults with post-COVID-19 pulmonary fibrosis and (2) to assess its impact on reducing disease morbidity/severity in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical evidence/diagnosis of interstitial lung disease (fibrosis) following COVID-19 infection
- •Aged at least 18 years
- •Willing and able to participate in the MONACO Cell Therapy Study
- •Signed and dated written informed consent.
排除标准
- •Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.
- •Malignant or premalignant haematological conditions
- •Serologically positive for antiHIV1,2; HBsAg; Anti-HBc; Anti-HCVab;Anti-HTLV1,2 or syphilis (Treponema palladium)
- •Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully treated non metastatic basal/squamous cell carcinoma of the skin)
- •Evidence of significant local or systemic infection
- •Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- •Clinical diagnosis of interstitial lung disease prior to the COVID-19 infection
- •Any condition which, in the judgement of the Investigator, would place the subject at undue risk
- •Female patients of childbearing potential with a positive serum pregnancy test at enrolment
- •Sexually active Women of Childbearing Potential who do not agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 4 weeks post IMP administration. Men who do not agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy after receiving the therapy
- •Female patients who are breastfeeding
- •Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow up visit schedule
- •Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- •Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).
结局指标
主要结局
Frequency of serious adverse events (SAE) related to the administration of the IMP
时间窗: Total number of SAEs at 12 months after administration
Any SAEs that result in death, are life-threatening, require hospitalisation or prolonged or existing hospitalisation (that are not determined to be as a result of disease progression) or result in persistent or significant disability or incapacity
次要结局
- Rate of decrease in FVC(3, 6 and 12 months)
- Absolute change from baseline of predicted forced vital capacity (FVC)(3, 6 and 12 months)
- Time to first occurrence of a ≥10% absolute decline in percentage of predicted FVC(3, 6 and 12 months)
- Time to decrease from baseline (relative change) of ≥ 10% in FVC (mL/year)(3, 6 and 12 months)
- Absolute change in transfer capacity of the lung (TLCO).(3, 6 and 12 months)
- Improvement in quality of life as indicated by the King's Brief Interstitial Lung Disease (K-BILD) score(3, 6 and 12 months)
- Reduction in fibrosis score on high resolution lung CT(6 and 12 months)
- Time from cell administration to first event of acute pulmonary fibrosis exacerbation(3, 6 and 12 months)
- Improvement in quality of life as indicated by the 36-Item Short Form Survey (SF-36) score(3, 6 and 12 months)