REcovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 3
- 主要终点
- SF-36 physical component score (PCS)
研究概览
简要总结
The researchers propose to develop a Canada-wide, adaptive randomized clinical platform trial to assess the effectiveness of various interventions in patients with lingering symptoms of COVID-19 ("Long COVID"). Participants will be randomized initially to 1 of 3 arms, including placebo (control) and 2 interventions. Because this is an adaptive trial, arms can be dropped if found to be ineffective and new arms can be added.
Interventions will last for 2 months and participants will be followed for an additional 4 months (6 months total). Approximately 800-1000 patients with Long COVID will be recruited across Canada. Results from this trial will accelerate the availability of high-quality, real-time evidence and solutions to enable Canada to improve the clinical care of patients with Long COVID.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to intervention in so far as the labelling of the study intervention. However, it is possible that the participant may figure out allocation arm, by the mode of administration, dosing frequency (once a day versus 3 times per day), and treatment form (pill, powder, intervention) etc.
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
- •Age ≥18 years;
- •Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15,
- •Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.
- •Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;
- •Lingering symptoms from COVID-19 present at the time of randomization.
- •Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.
- •Must be able to provide informed consent and both willing and able to comply with study requirements.
排除标准
- •Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;
- •Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;
- •Contraindications to all of the study interventions;
- •Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);
- •Currently pregnant or breastfeeding.
研究组 & 干预措施
IBUDILAST
Participants will receive 20 mg dose (2 pills) twice per day taken by mouth.
干预措施: Ibudilast (Drug)
PENTOXIFYLLINE
Participants will receive a 400mg dose (1 pill) 3 times per day taken by mouth.
干预措施: Pentoxifylline (Drug)
PLACEBO
Participants will receive 2 placebo pills twice per day taken by mouth OR 1 placebo pill 3 times a day taken by mouth.
干预措施: Placebo (Other)
结局指标
主要结局
SF-36 physical component score (PCS)
时间窗: from baseline to two months
mean change in the SF-36 (v.1) physical component score (PCS)
次要结局
- Reintegration to Normal Living Index (RNLI)(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Fatigue Scale(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Post-Exertional Malaise(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Mental Health - Patient Health Questionnaire (PHQ-9)(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Symptoms scale(Baseline/Randomization weekly to 2 months, then once monthly to 6 months.)
- Post COVID19 functional status scale(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Symptom Checklist(Baseline/Randomization weekly to 2 months, then once monthly to 6 months.)
- Dyspnea(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Blood samples(Baseline/Randomization and 2 months)
- Six Minute Walking Test (6MWT) with oximetry(Baseline/Randomization and 2 months)
- TestMyBrain cognitive testing(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Brief Fatigue inventory(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Mental Health - Post-traumatic Stress Disorder Checklist (PCL-5)(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Mental Health - General Anxiety Assessment Form (GAD-7)(Baseline/Randomization to 1, 2 months 3 and 6 months)
- Mental Health Composite score (MCS) of the SF-36(Baseline/Randomization to 1, 2 months 3 and 6 months)