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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Daily doses of NB-UVB for 8 consecutive days.
Daily doses of non-NB-UVB for 8 consecutive days.
West Jefferson Medical Center and LSUHSC-NO
New Orleans, Louisiana, United States
Mortality Rate
% Patient Mortality
Time frame: 14 days
Mortality Rate
% Patient Mortality
Time frame: 28 days
WHO Ordinal Scale for Clinical Improvement
Improvement in WHO Ordinal Scale
Time frame: 14 days
WHO Ordinal Scale for Clinical Improvement
Improvement in WHO Ordinal Scale
Time frame: 28 days
Length of Hospital Stay
Days from Treatment to Discharge
Time frame: 28 days
Rate of Escalation to the ICU
% of Patients Escalating to the ICU
Time frame: day 14
Rate of Ventilator Support (intubation) requirement
% of Patients Requiring Ventilator Support (intubation)
Time frame: day 28
Rate of Improved Immune Regulation as measured by (Any 3 of These):
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
Time frame: 28 days
Rate of Stabilization of the Immune Dysregulation (all 3 of These)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1. Decreased Th l and Th 17; 2. Increased Th2; 3. Increased circulating regulatory T Cells
Time frame: 28 days
Average Reduction in Inflammatory Markers:
HS-CRP (mg/L)
Time frame: 28 days
Average Reduction in Inflammatory Markers:
LDH (units per liter (U/L))
Time frame: 28 days
Average Reduction in Inflammatory Markers:
Ferritin (micrograms/L)
Time frame: 28 days
Improved Hemostatic Regulation by D-dimer Reduction
D-dimer (ng/mL)
Time frame: 28 days
Improved Hemostatic Regulation by reduce PTT
Partial Thromboplastin Time (PTT) Test
Time frame: 28 days
Average Reduced Viral Load.
Reduced viral load (copies/mL)
Time frame: 28 days
Average and Categorical Increase in Vitamin D:
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);
Time frame: 28 days
% of Patients with a Change in oxygen requirement
1. Non-invasive positive pressure support (BiPAP \& CPAP) 2. Discharge from the ICU 3. Removal from Ventilator Support
Time frame: 28 days
Average Temperature
1. (Average for each day) - Hospital Staff 2. (Highest Record of the day) - Hospital Staff
Time frame: 28 days
Average Length of Hospitalization
Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization
Time frame: 28 days