Long-term Follow-up of a Randomized Multicenter Trial on Impact of Imatinib and Infliximab on Long-COVID in Hospitalized COVID-19 Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Long-COVID symptoms
研究概览
简要总结
The SOLIDARITY PLUS Finland Long-COVID trial aims to assess the long-term effects of imatinib and infliximab, used during acute hospitalization due to COVID-19-infection, on long-COVID symptoms and quality of life (QoL) using questionnaires at six months, one and two years post-discharge. The primary research questions are whether imatinib or infliximab lower the risk of long-COVID symptoms and leads to better QoL in the long term.
Objectives include:
i) Long-COVID symptoms
To investigate the effect of imatinib (vs. usual care only) and infliximab (vs. usual care only) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place at six months, one and two years after the hospital admission. The questionnaire will be the same that has been used in the SOLIDARITY Finland Long-COVID trial on remdesivir. The questionnaire was developed by our multidisciplinary team of physicians, including the representation of multiple specialties such as general practice, lung diseases, neurology, internal medicine, rheumatology, genetics, and clinical epidemiology, and two patient partners.
The symptom questionnaire - that will be completed by patients at one and two years - measures basic patient information (age, height, weight, smoking status, major comorbidity, and working status) and a wide variety of potential long-COVID-symptoms and their bother (1. Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping difficulties; 5. Depressive mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus; 10. Paresthesias; 11. Changes in taste/smell perceptions; 12. Postexertional malaise; 13. Palpitations; 14. Chest discomfort; 15. Nausea; 16. Skin rash; 17. Joint aches; 18. Muscle pains; 19. Continuous cough; 20. Respiratory tract mucous discharges).
ii) Quality of life
The EQ-5D-5L questionnaire will be used to compare patients' quality of life in imatinib, infliximab, and usual care arms.
EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3. Usual activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The visual analog scale of subjective perception of overall health.
Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions):
- The Finnish healthcare registries (such as Statistics Finland Mortality Database, the HILMO Care Register for Health Care, and/or Digital and Population Data Services Agency (Finnish Digital Agency)) will be used to estimate long-term mortality and incidence of major comorbidity in treatment arms.
- Lung function will be assessed using spirometry and diffusing capacity, as well as the six-minute walk test (6 mwt) in treatment arms.
- Whole-genome genotyping will be performed for a genome-wide association study to investigate genetic correlates of long-COVID-19 -symptoms in treatment arms.
详细描述
The SOLIDARITY Finland Plus Long-COVID is the long-term follow-up of the SOLIDARITY Finland Plus trial. With local adjustments, this clinical trial follows the WHO core protocol. SOLIDARITY Finland (Plus) is an adaptive, randomized, open-label clinical trial evaluating the safety and efficacy of imatinib, infliximab, and local standard of care in hospitalized adult patients diagnosed with COVID-19.)
Study population:
The study population consists of adult patients (18 years and older) with laboratory-confirmed SARS-2-CoV-2, who are admitted to the hospital ward or the intensive care unit (ICU). Adult hospital patients, with definite COVID-19 and, as per the responsible doctor, no contraindication to the study drugs were entered into the online electronic data collection system and randomly allocated (1:1:1, if no contraindications) between:
- the local standard of care alone or
- local standard of care plus oral imatinib (until discharge or up to 14 days) or
- local standard of care plus a single intravenous infusion of infliximab.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label trial
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
- •Adult patients, 18 years and above
- •SARS-2-CoV-2 infection, laboratory-confirmed
- •Admission to the hospital ward or ICU
- •Written informed consent prior to initiation of the study or a close relative/legal representative provides written informed consent prior to initiation of the study according to the presumed will of the patient when the patient is unable to give consent herself/himself.
- •No anticipated transfer within 72 hours to a non-study hospital
排除标准
- •Estimated life expectancy under three months due to severe comorbidity
- •ASAT/ALAT-ratio over five-fold upper limit
- •Acute myocardial infarction or unstable angina pectoris
- •Breast feeding or pregnancy
- •Any reason why, in the opinion of the investigators, the patient should not participate
- •Patient participates in a potentially confounding drug or device trial during the course of the study
- •Already receiving any of the study drugs
- •Severe renal failure (eGFR < 30 mL/min)
研究组 & 干预措施
Imatinib + local standard of care
干预措施: Imatinib (Drug)
Infliximab + local standard of care
干预措施: Infliximab (Drug)
结局指标
主要结局
Long-COVID symptoms
时间窗: At two years from hospital admission.
Specific questionnaire for symptoms and their severity
Health-related quality of life
时间窗: At two years from hospital admission
EQ-5D-5L questionnaire
次要结局
- Lung function(At two years from hospital admission)
- Whole-genome sequencing(Within 2 years from hospital discharge)
- Mortality(During one and two years from hospital admission)
- Incidence of comorbidity(During two years from hospital admission)
研究者
Kari Tikkinen
Professor
University of Helsinki