NCT04433949进行中（未招募）3 期
Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19 (RESCUE 1-19): A Randomized Phase III Trial of Best Supportive Care Plus Provider's Choice of Pharmaceutical Treatment With or Without Whole Lung Low-Dose Radiation Therapy (LD-RT) in Hospitalized Patients With COVID-19
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Time to clinical recovery
研究概览
简要总结
This phase III trial compares low dose whole lung radiation therapy to best supportive care plus physicians choice in treating patients with COVID-19 infection. Low dose whole lung radiation therapy may work better than the current best supportive care and physician's choice in improving patients' clinical status, the radiographic appearance of their lungs, or their laboratory blood tests.
详细描述
PRIMARY OBJECTIVE:
I. Intubation-free survival (IFS) and (2) time to clinical recovery (TTCR) based on weaning off supplementary oxygenation or hospital discharge in COVID 19 patients.
SECONDARY OBJECTIVES:
I. To investigate (1) other clinical, (2) radiographic, (3) serologic markers, and (4) immune marker response to best supportive care plus provider's choice of pharmaceutical treatment either with or without whole-lung LD-RT
II. Secondary clinical improvements will look at time to hospital discharge, prevention of ICU admissions, and overall survival.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be age 50 or over; Not pregnant (will undergo pregnancy testing if below age 55);
- •Have had a positive PCR-based test confirming the diagnosis of COVID-19 within 5 days (+/-2 day)of study enrollment*
- •Have had clinical signs of severe acute respiratory syndrome or pneumonia (ie. dyspnea, cough,fever) that primary team feels like patient needs rescuing with LD-RT.**
- •Have visible bilateral consolidations/ground glass opacities on chest imaging
- •Require supplemental oxygen at the time of enrollment, defined by inability to wean from supplemental oxygen within 24 hours prior to enrollment.
- •Not require intubation within 12 hours of randomization (ie, not screen fail). Intubation after enrollment but within 12 hours of randomization will be defined as a screen failure for both the LD-RT and control cohorts.
- •Be enrolled within 5 days (+/- 2) of first hospitalization for COVID-
- •Prior hospitalization for COVID-19 will be an exclusion criteria (prior ED visits are permissible).
- •Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
- •Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
排除标准
- •Pregnant and/or planned to be pregnant within in next 6 months
- •Age 49 or younger at time of enrollment
- •Prior inpatient hospitalization for COVID-19 (prior emergency department [ED] visits are not an exclusion criteria)
- •Prior enrollment on a separate COVID-19-related therapeutric trial (subsequent co-enrollment is permitted for patinets randomized to the control arm).
- •Notably, concurrent use of COVID-directed therapies is no longer an exclusion criteria for this trial. This includes azithromycin, dexamethasone, remdesevir, convalescent plasma, or any other COVIDdirected drug therapy.
结局指标
主要结局
Time to clinical recovery
时间窗: Up to follow-up day 14 after study start
Will be measured by improvements on oxygenation need prior to intervention compared with after intervention and/or hospital discharge.
次要结局
- Freedom from ICU admission(Up to follow-up day 14 after study start; This may be extended up to 28 days after preplanned interim analysis.)
- Temperature(Up to follow-up day 14 after study start)
- Heart rate(Up to follow-up day 14 after study start)
- Systolic Blood pressure(Up to follow-up day 14 after study start)
- Glasgow Comma Scale from minimum of 3 to maximum of 15.(Up to follow-up day 14 after study start)
- Performance status(Up to follow-up day 14 after study start)
- Survival(Up to follow-up day 14 after study start; This may be extended to 28 days after preplanned interim analysis.)
- Serum chemistry + complete blood cell (CBC) with differential(Up to follow-up day 14 after study start)
- Albumin(Up to follow-up day 14 after study start)
- Procalcitonin(Up to follow-up day 14 after study start)
- Aspartate aminotransferase (AST)(Up to follow-up day 14 after study start)
- Oxygen saturation(Up to follow-up day 14 after study start)
- Respiratory rate(Up to follow-up day 14 after study start)
- Serial chest x-rays severe acute respiratory syndrome (SARS) scoring(Up to follow-up day 14 after study start;)
- Blood gases pH(when available)(Up to follow-up day 14 after study start)
- NT-pBNP (cardiac injury)(Up to follow-up day 14 after study start)
- Gamma-glutamyl transferase (GGT)(Up to follow-up day 14 after study start)
- Supplemental oxygenation need(Up to follow-up day 14 after study start)
- Changes on computed tomography (CT) scans pre and post RT(Baseline up to follow-up day 14 after study start)
- CRP(Up to follow-up day 14 after study start)
- Creatine kinase(Up to follow-up day 14 after study start)
- Prothrombin time (PT)/partial thromboplastin time (PTT)(Up to follow-up day 14 after study start)
- Troponin(Up to follow-up day 14 after study start)
- Lactate(Up to follow-up day 14 after study start)
- Fibrinogen(Up to follow-up day 14 after study start)
- Changes in CD8 T cells(Up to follow-up day 14 after study start)
- LDH(Up to follow-up day 14 after study start)
- Myoglobin(Up to follow-up day 14 after study start)
- Triglycerides(Up to follow-up day 14 after study start)
- Changes in CD4 T cells(Up to follow-up day 14 after study start)
- Changes in serum antibodies against COVID-19 epitope(Up to follow-up day 14 after study start)
- D-Dimer(Up to follow-up day 14 after study start)
- IL-6(Up to follow-up day 14 after study start)
- Potassium(Up to follow-up day 14 after study start)
- Ferritin(Up to follow-up day 14 after study start)
- ALT(Up to follow-up day 14 after study start)
研究者
Mohammad K. Khan
Principal Investigator
Emory University
研究点 (2)
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