Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
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|ClinicalTrials.gov Identifier: NCT04818970|
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : May 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Corona Virus Infection Autoimmune Diseases Coagulation Disorder, Blood||Device: Narrow Band ultraviolet B-Band Light Device: non Narrow Band ultraviolet B-Band Light||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 Randomized Placebo Control Trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||May 21, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Phototherapy of narrow band ultraviolet Light B-Band NB-UVB
Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.
Device: Narrow Band ultraviolet B-Band Light
Daily doses of NB-UVB for 8 consecutive days.
Other Name: Phototherapy
Placebo Comparator: Placebo - Light
Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.
Device: non Narrow Band ultraviolet B-Band Light
Daily doses of non-NB-UVB for 8 consecutive days.
Other Name: Placebo
- Mortality Rate [ Time Frame: 14 days ]% Patient Mortality
- Mortality Rate [ Time Frame: 28 days ]% Patient Mortality
- WHO Ordinal Scale for Clinical Improvement [ Time Frame: 14 days ]Improvement in WHO Ordinal Scale
- WHO Ordinal Scale for Clinical Improvement [ Time Frame: 28 days ]Improvement in WHO Ordinal Scale
- Length of Hospital Stay [ Time Frame: 28 days ]Days from Treatment to Discharge
- Rate of Escalation to the ICU [ Time Frame: day 14 ]% of Patients Escalating to the ICU
- Rate of Ventilator Support (intubation) requirement [ Time Frame: day 28 ]% of Patients Requiring Ventilator Support (intubation)
- Rate of Improved Immune Regulation as measured by (Any 3 of These): [ Time Frame: 28 days ]
- Increased ratio of CD8 perforin to Monocyte IL6,
- Increased ratio ofNK perforin to Monocyte IL6
- Increased ratio of CD4 lFNg to Monocyte IL6
- Increased ratio of CD8 perforin to Monocyte TNF
- Increased ratio ofNK perforin to Monocyte TNF, and
- Increased ratio of CD4 IFNg to Monocyte TNF
- Rate of Stabilization of the Immune Dysregulation (all 3 of These) [ Time Frame: 28 days ]
- Decreased Th l and Th 17;
- Increased Th2;
- Increased circulating regulatory T Cells
- Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]HS-CRP (mg/L)
- Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]LDH (units per liter (U/L))
- Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]Ferritin (micrograms/L)
- Improved Hemostatic Regulation by D-dimer Reduction [ Time Frame: 28 days ]D-dimer (ng/mL)
- Improved Hemostatic Regulation by reduce PTT [ Time Frame: 28 days ]Partial Thromboplastin Time (PTT) Test
- Average Reduced Viral Load. [ Time Frame: 28 days ]Reduced viral load (copies/mL)
- Average and Categorical Increase in Vitamin D: [ Time Frame: 28 days ]
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);
- Active 1,25-dihydroxyvitamin D and
i. % of Patients with Improvement from Insufficient (at min. of 18pg/ml);
- % of Patients with a Change in oxygen requirement [ Time Frame: 28 days ]
- Non-invasive positive pressure support (BiPAP & CPAP)
- Discharge from the ICU
- Removal from Ventilator Support
- Average Temperature [ Time Frame: 28 days ]
- (Average for each day) - Hospital Staff
- (Highest Record of the day) - Hospital Staff
- Average Length of Hospitalization [ Time Frame: 28 days ]Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818970
|Contact: Frank H Lau, MDemail@example.com|
|Contact: Ann D McKendrick, MSWfirstname.lastname@example.org|
|Principal Investigator:||Frank H Lau, MD||Louisiana State University Health Sciences Center in New Orleans|