Adaptive Photo-Protection Trial: To Demonstrate the Safety and Efficacy of NB-UVB Light Therapy to Improve Outcomes in Hospitalized High-risk Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- WHO Ordinal Scale for Clinical Improvement
研究概览
简要总结
The purpose of this study to evaluate the translational application of the safe and effective treatment of Narrow-Band Ultraviolet light B-band (NB-UVB) to high-risk COVID-19 patients in an effort to improve their immune and hemostatic imbalance to increase survival and improve outcomes.
详细描述
Study Design
This is a multi-center, double blind, randomized control trial designed to assess the safety and efficacy of daily NB-UVB light for patients presenting to site hospitals over the age of 50 with a positive COVID-19 panel and at least one comorbidity.
This trial provides adjunctive therapy and no in-hospital treatments need to be modified in any way. The sponsor and the centers acknowledge standards of care are actively evolving and this trial is not intended to interfere in any form.
Double Blind: Patient and Health care provider will be blinded to the treatment vs. placebo by use of a non-NB-UVB light card. All dosing and times for treatment and placebo will be calculated the same methods.
Arm A: Control: Will receive non-NB-UVB light during the Treatment Period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 50 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to enroll in the study, subjects must be:
- •In-Hospital
- •50 years of age or older
- •Hospitalized for COVID-I9 symptoms
- •At least one comorbidity.
- •They have taken a COVID-19 diagnostic test.
- •Peripheral 02 saturation below 94 on room air, nasal cannula or non-rebreather
- •Patients may remain enrolled as long as they remain hospitalized for
- •COVID-19 symptoms and receive a positive test panel for COVID-19
- •during the treatment phase
- •Be able to provide consent.
排除标准
- •To be eligible to enroll in the study, subjects must not:
- •Require ventilatory support at the time of enrollment.
- •Concurrent pulmonary bacterial infection
- •Taking Light Sensitive Medications
- •Have Lupus Diagnosis
- •Enrolled in an existing Covid-19 Trial
- •Taking In-patient Vitamin oral Supplementation
- •Severe mental or medical disability
- •History of melanoma or dysplastic nevus syndrome
- •Active tuberculosis or Cystic Fibrosis, Severe Chronic Obstructive Pulmonary Disease (COPD) or Pulmonary Fibrosis requiring home supplemental oxygen
- •Pre-existing pulmonary hypertension
- •INR > 2, LFT 6 times greater than baseline
- •Stage 3b CKD or ESRD diagnosis before COVID-19 onset
- •Evidence of cirrhosis
- •Evidence of pre-existing vascular disorder or coagulopathy
- •Irreversible bleeding disorder
- •Patients who are not full code
- •Taking oral light sensitizing medications (See Appendix) or using light sensitizing topical
- •medication in the phototherapy treatment zones
- •Taking in patient or at home Vitamin D supplementation
- •Have any photosensitive skin disorder such as Systemic Lupus Erythematosus, Porphyria or
- •Pseudoporphyria, Polymorphous Light Eruption Xeroderma Pigmentosa, Chronic actinic
- •dermatitis, Hydroa vacciniforme, Dermatomyositis Bloom Syndrome, Rothmund Thomas
- •syndrome, Cockayne Syndrome
- •Requiring oxygen supplementation via CPAP/BiPAP, ventilator support, High Flow Nasal
- •Prong therapy (HFNP)
- •Concurrent pulmonary bacterial infection at the time of enrollment
- •Previous hospital admission for COVID-19 symptoms
结局指标
主要结局
WHO Ordinal Scale for Clinical Improvement
时间窗: 28 days
Improvement in WHO Ordinal Scale
Rate of Ventilator Support (intubation) requirement
时间窗: day 28
% of Patients Requiring Ventilator Support (intubation)
Mortality Rate
时间窗: 28 days
% Patient Mortality
Length of Hospital Stay
时间窗: 28 days
Days from Treatment to Discharge
Rate of Escalation to the ICU
时间窗: day 14
% of Patients Escalating to the ICU
次要结局
- Improved Hemostatic Regulation by reduce PTT(28 days)
- Average Reduced Viral Load.(28 days)
- Average Reduction in Inflammatory Markers:(28 days)
- Rate of Stabilization of the Immune Dysregulation (all 3 of These)(28 days)
- Improved Hemostatic Regulation by D-dimer Reduction(28 days)
- Average Temperature(28 days)
- Average and Categorical Increase in Vitamin D:(28 days)
- Rate of Improved Immune Regulation as measured by (Any 3 of These):(28 days)
- % of Patients with a Change in oxygen requirement(28 days)
- Average Length of Hospitalization(28 days)