ISRCTN33260034终止2 期
Adalimumab in COVID-19 to prevent respiratory failure in community care (AVID-CC): A randomised controlled trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Confirmed SARS-CoV-2 infection based on a validated test
- •3. CRP >50 mg/l or lymphopaenia (<1.5 x 10(9)/l) or neutrophilia (>7.5 x 10(9)/l)
- •4. Oxygen saturation >93% on air (pulse oximeter)
- •Note: Point of care testing and the associated results are acceptable for assessment of eligibility
排除标准
- •1. Subject is considered to be in their last few weeks of life prior to this acute illness
- •2. Clinical frailty score of 8 or 9 prior to this acute illness
- •3. History of haematopoietic stem cell transplant or solid organ transplant
- •4. Chronic obstructive pulmonary disease (COPD) on long term oxygen therapy (Subjects with FEV1 known to be <50% will also be excluded)
- •5. Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants
- •6. Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma
- •7. Current participation in another therapeutic interventional clinical study for COVID-19
- •8. De-myelinating disease
- •9. Known to be co-infected with Hepatitis B Virus, HIV
- •10. Severe hepatic impairment
- •11. Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm)
- •12. Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.
- •13. Moderate or severe heart failure (NYHA class III/IV)
- •14. Treatment with anti-TNF drug in past 180 days (9 half lives of the drug)
- •15. Pregnancy
- •16. Lactating females
- •17. Women of childbearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the study and 5 months afterwards
研究者
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