Long-term Follow-up of a Randomized Multicenter Trial on Impact of Long-COVID in Hospitalized COVID-19 Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- EQ-VAS
研究概览
简要总结
SOLIDARITY Finland Long-COVID trial assesses the effects of remdesivir + standard of care (SoC) vs. only SoC on long-COVID symptoms and quality of life (QoL) using questionnaires at one and two years post-discharge.
Objectives i) Long-COVID symptoms
- To investigate the effect of remdesivir (vs. SoC) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place 1 and 2 years after the hospital admission.
- 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) in remdesivir and usual care arms
ii) Quality of life
- EQ-VAS: to compare patients' quality of life in remdesivir 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 VAS of subjective perception of overall health.
Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions; currently the study has ethical approval for long-COVID and quality of life assessments only):
- The Finnish healthcare registries (Statistics Finland Mortality Database and the HILMO Care Register for Health Care) will be used to estimate long-term mortality and incidence of major comorbidity in remdesivir and usual care arms
- Lung function will be assessed using spirometry and diffusing capacity, as well as the six-minute walk test (6 mwt) in remdesivir and usual care arms
- Whole-genome genotyping will be performed for a genome-wide association study to investigate genetic correlates of long-COVID-19 -symptoms in remdesivir and usual care arms
UPDATE 02.02.2022:
Primary outcomes will comprise the following:
- EQ-VAS
- EQ-5D-5L, summary
- Does the patient feel recovered from COVID-19-infection at one year or not? (question no. 10)
- Fatigue (questionnaire, question no. 14)
- Exertional dyspnea (question no. 12)
详细描述
The SOLIDARITY Finland Long-COVID is the long-term follow-up of the remdesivir sub-study of the SOLIDARITY Finland. (Following the WHO core protocol with local adjustments, the SOLIDARITY Finland is an adaptive, randomized, open-label clinical trial evaluating the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19.)
Study population Adult patients with confirmed SARS-2-CoV-2 admitted to the hospital ward or the intensive care unit (ICU) were included. 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 between the local standard of care alone or local standard of care plus remdesivir (daily infusion until discharge or up to ten days). Between July 2020 and January 2021, 208 patients were recruited from 13 hospitals, of which 114 were randomized to receive remdesivir plus usual care and 94 to receive usual care only. (These patients (if alive; n=202 or less) will be invited to participate in the SOLIDARITY Finland Long-COVID.) During patient recruitment at the hospital phase of the study, the following data was collected: 1) hospital and randomizing doctor; 2) confirmation that patient has provided consent, 3) patient identifiers, age, and sex, 4) major comorbidities, 5) COVID severity.
Consent:
All patients have already consented to SOLIDARITY Finland (in-hospital study). In the SOLIDARITY Finland Long-COVID, patients will receive, by mail, an information letter, consent form, and questionnaires. The mail will be sent three days before the anniversary of the randomization day during hospitalisation. They may reply by i) sending back the completed documents, ii) scheduling a phone call with an investigator for an interview, or iii) declining participation. If the patient does not reply in 14 days (from the day the investigators sent the questionnaire to the patient), the investigators will send one reminder by mail and, if there will not be a reply, then the investigators will approach the patient via telephone at around 10 days from the reminder mail. The phone call will be attempted twice: during and after office hours. If the patient will not answer the phone, the investigators will also send a text message to inform them about the reason for our attempted phone call.
Questionnaire (symptoms and characteristics):
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
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
- •Alive patients who attended the SOLIDARITY Finland remdesivir sub-study
- •Eligibility criteria for SOLIDARITY Finland remdesivir -study:
- •Inclusion criteria:
- •Adult patients, 18 years and older
- •Laboratory-confirmed SARS-CoV-2 infection
- •Admitted to the hospital ward or the intensive care unit (ICU)
- •Patient provides written informed consent prior to initiation of the study OR close relative/legal representative provides written informed consent prior to initiation of the study according to the presumed will of the patient when patient is unable to give consent.
- •No anticipated transfer within 72 hours to a non-study hospital
排除标准
- •Severe co-morbidity with life expectancy <3 months according to investigators assessment
- •ASAT/ALAT > 5 times the upper limit of normal
- •Acute co-morbidity within 7 days before inclusion such as myocardial infarction or unstable angina pectoris (not including troponin elevation due to infection)
- •Pregnancy or breast feeding
- •Any reason why, in the opinion of the investigators, the patient should not participate
- •Subject participates in a potentially confounding drug or device trial during the course of the study
- •Already receiving the study drug
- •Renal failure (eGRF < 30 mL/min) or dialysis/continuous veno-venous hemofiltration
研究组 & 干预措施
Standard of care plus remdesivir
Local standard of care plus daily remdesivir infusion for up to 10 days (or until discharge)
干预措施: Remdesivir (Drug)
结局指标
主要结局
EQ-VAS
时间窗: 1 year
EQ-VAS is a patient-reported outcome measure of quality of life on a scale from 0 to 100. The minimum scores mean a worse outcome.
EQ-5D-5L
时间窗: 1 year
Quality of life measure of five domains, including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Exertional dyspnea
时间窗: 1 year
mMRC scale measures the degree of disability that breathlessness poses on everyday activities on a scale from 0 to 4.
Long-COVID symptoms
时间窗: 1 year
Infection affected quality of life in the last month as: 0 = No symptoms of infection, 1 = Slight harm, 2 = Moderate harm, 3 = Severe harm
Recovering from COVID-19 infection
时间窗: 1 year
Question: How do you feel you have recovered from the COVID-19 infection you had one year ago? Five options from "fully recovered" to "not recovered at all"
Fatigue
时间窗: 1 year
The presence of fatigue as: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, and 3 = severe fatigue.
次要结局
- EQ-VAS(2 year)
- EQ-5D-5L(2 year)
- Exertional dyspnea(2 year)
- Long-COVID symptoms(2 year)
- Recovering from COVID-19 infection(2 year)
- Fatigue(2 year)
研究者
Kari Tikkinen
Professor
Clinical Urology and Epidemiology Working Group