EUCTR2020-003628-18-GB进行中（未招募）1 期
Adalimumab in COVID-19 to present respiratory failure in community care (AVID-CC): A randomised controlled trial - AVID-CC study
niversity of Oxford, Clinical Trials and Research Governance0 个研究点目标入组 750 人开始时间: 2020年9月7日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
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
- •Participants are eligible for the trial if all of the following are true:
- •Aged at = 18 years
- •Confirmed SARS-CoV-2 infection based on a validated test
- •CRP >50 mg/L or Lymphopaenia (<1.5 x 109/L) or Neutrophilia (>7.5 x 109/L)
- •Oxygen saturation >93% on air (pulse oximeter)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 650
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •Subject is considered to be in their last few weeks of life prior to this acute illness
- •Clinical frailty score of 8 or 9 prior to this acute illness
- •oNote that acute delirium is not an exclusion
- •History of haematopoietic stem cell transplant or solid organ transplant
- •Chronic Obstructive Pulmonary Disease on long term oxygen therapy
- •oSubjects with FEV1 known to be <50% will also be excluded
- •Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants
- •Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma
- •Current participation in another therapeutic interventional clinical study for COVID-19
- •De-myelinating disease
- •Known to be co-infected with Hepatitis B Virus, HIV
- •Severe hepatic impairment
- •Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm)
- •Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.
- •Moderate or severe heart failure (NYHA class III/IV)
- •Treatment with anti-TNF drug in past 180 days (9 half lives of the drug)
- •Lactating females
- •Women of child bearing 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
相似试验
终止
2 期
Adalimumab for coronavirus in community careCOVID-19 (SARS-CoV-2 infection)Infections and InfestationsISRCTN33260034niversity of Oxford
进行中（未招募）
1 期
anadelumab for treatment of COVID-19 diseaseCOVID-19MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsEUCTR2020-002472-12-NLRadboud University Medical Center80
已完成
不适用
anadelumab for treatment of COVID-19 disease10047438corona virusCOVID-19NL-OMON55152Radboud Universitair Medisch Centrum43
已完成
不适用
Clinical Effectiveness of Adalimumab (Exemptiaâ?¢) in patients suffering from symptomatic Ankylosing Spondylitis (AS) under supervised standard rheumatology careCTRI/2018/02/012018CENTER FOR RHEUMATIC DISEASES50
已完成
2 期
Thalidomide and moderate COVID-19 pneumoniaIRCT20210614051574N5Shahid Beheshti University of Medical Sciences100