Autoimmune Diseases, Coagulation Disorder, Blood, Corona Virus Infection, Covid19
Conditions
Keywords
Narrow Band Ultraviolet Light B-Band, NB-UVB, Immune Dysregulation, Vitamin D
Brief summary
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.
Detailed description
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. Arm B: Treatment: Will receive NB-UVB light during the Treatment Period. Treatment Phase (Days 1-8): Treatment Schedule will be identical for arm A and B. Follow Up Phase (Days 9-28 or discharge): Follow-up will be identical for arms A and B. Blood Draw Schedule: Blood draws are to be performed after enrollment, before the first treatment day 1 and on days 3, 5, 8, 14 and day of discharge (if prior to day 14 unless blood draw has already occurred within one day of discharge).
Interventions
DEVICENarrow Band ultraviolet B-Band Light
Daily doses of NB-UVB for 8 consecutive days.
DEVICEnon Narrow Band ultraviolet B-Band Light
Daily doses of non-NB-UVB for 8 consecutive days.
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Baylor College of Medicine
West Jefferson Medical Center
Cytokind, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Intervention model description
1:1 Randomized Placebo Control Trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
\- 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.
Exclusion criteria
\- 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 * Prisoner * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | 14 days | % Patient Mortality |
| WHO Ordinal Scale for Clinical Improvement | 14 days | Improvement in WHO Ordinal Scale |
| Length of Hospital Stay | 28 days | Days from Treatment to Discharge |
| Rate of Escalation to the ICU | day 14 | % of Patients Escalating to the ICU |
| Rate of Ventilator Support (intubation) requirement | day 28 | % of Patients Requiring Ventilator Support (intubation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Reduced Viral Load. | 28 days | Reduced viral load (copies/mL) |
| Average and Categorical Increase in Vitamin D: | 28 days | 1. 25(OH)D hydroxyvitamin D 1\. % of Patients Improving from Critical Deficiency (min. of 20ng/ml); ii. % of Patients Improving from Insufficiency (at min. of 30ng/ml); 2. Active 1,25-dihydroxyvitamin D and i. % of Patients with Improvement from Insufficient (at min. of 18pg/ml); |
| Rate of Improved Immune Regulation as measured by (Any 3 of These): | 28 days | 1. Increased ratio of CD8 perforin to Monocyte IL6, 2. Increased ratio ofNK perforin to Monocyte IL6 3. Increased ratio of CD4 lFNg to Monocyte IL6 4. Increased ratio of CD8 perforin to Monocyte TNF 5. Increased ratio ofNK perforin to Monocyte TNF, and 6. Increased ratio of CD4 IFNg to Monocyte TNF |
| Average Temperature | 28 days | 1. (Average for each day) - Hospital Staff 2. (Highest Record of the day) - Hospital Staff |
| Average Length of Hospitalization | 28 days | Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization |
| % of Patients with a Change in oxygen requirement | 28 days | 1. Non-invasive positive pressure support (BiPAP & CPAP) 2. Discharge from the ICU 3. Removal from Ventilator Support |
| Rate of Stabilization of the Immune Dysregulation (all 3 of These) | 28 days | 1. Decreased Th l and Th 17; 2. Increased Th2; 3. Increased circulating regulatory T Cells |
| Average Reduction in Inflammatory Markers: | 28 days | HS-CRP (mg/L) |
| Improved Hemostatic Regulation by D-dimer Reduction | 28 days | D-dimer (ng/mL) |
| Improved Hemostatic Regulation by reduce PTT | 28 days | Partial Thromboplastin Time (PTT) Test |
Countries
United States
Outcome results
None listed