EUCTR2021-002098-25-DE进行中（未招募）1 期
A randomized, controlled, multicenter, open label phase II clinical studyto evaluate infliximab in the treatment of patients with severe COVID-19 disease (INFLIXCOVID) - INFLIXCOVID
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Infection with SARS-CoV-2 (virus detection by means of a PCR test not older than 72 hours)
- •Bipulmonary infiltrates (detection by means of X-rays or computed tomography)
- •COVID inflammation score = 10 (see Appendix of study protocol 14.1)
- •Ferritin concentration (serum or plasma) = 500 ng / ml
- •Arterial oxygen saturation = 93% when breathing room air
- •written informed consent from the patient
- •Potentially childbearing women: negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •In medical history:
- •Contraindications study medication:
- •Hypersensitivity to the active substance infliximab (or any of the other ingredients of the medicine) or to other murine proteins
- •active or latent tuberculosis
- •acute or chronic hepatitis B
- •severe infections such as invasive fungal infections, bacterial sepsis, or abscesses
- •opportunistic infections (e.g. pneumocystosis, listeriosis)
- •moderate or severe heart failure (NYHA class III / IV)
- •Immunosuppression (e.g. organ transplantation, AIDS, leukopenia)
- •Malignancies or lymphoproliferative diseases or chemotherapy within the last 4 weeks
- •Multiple sclerosis or peripheral demyelinating diseases, including the Guillain-Barré syndrome
- •Treatment with other biologics for therapy for approved indications of infliximab (e.g. for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis)
- •Further exclusion criteria:
- •Autoimmune disease with biologics therapy
- •Current treatment with TNF antibodies, convalescent plasma, bamlanivimab, or other experimental treatments for COVID-19
- •High-flow oxygen therapy, non-invasive / invasive ventilation (WHO-COVID-19 PROGRESSION Scale> 5)
- •pre-existing long-term ventilation or home oxygen therapy
- •Child-Pugh C liver cirrhosis
- •Pregnancy or breastfeeding
- •Patients with a life expectancy <90 days due to other medical conditions
- •Limitation or discontinuation of therapy (e.g. refusal of artificial ventilation)
- •Participation in another interventional study
- •Previous participation in this study
- •Interdependence between the patient and the coordinating investigator or other members of the study team
研究者
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