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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| Baylor College of Medicine | OTHER |
| West Jefferson Medical Center | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phototherapy of narrow band ultraviolet Light B-Band NB-UVB | Experimental | Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm. |
|
| Placebo - Light | Placebo Comparator | Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow Band ultraviolet B-Band Light | Device | Daily doses of NB-UVB for 8 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | % Patient Mortality | 14 days |
| Mortality Rate | % Patient Mortality | 28 days |
| WHO Ordinal Scale for Clinical Improvement | Improvement in WHO Ordinal Scale | 14 days |
| WHO Ordinal Scale for Clinical Improvement | Improvement in WHO Ordinal Scale | 28 days |
| Length of Hospital Stay | Days from Treatment to Discharge | 28 days |
| Rate of Escalation to the ICU | % of Patients Escalating to the ICU | day 14 |
| Rate of Ventilator Support (intubation) requirement | % of Patients Requiring Ventilator Support (intubation) | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Improved Immune Regulation as measured by (Any 3 of These): |
| 28 days |
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Inclusion Criteria:
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To be eligible to enroll in the study, subjects must be:
Exclusion Criteria:
-
To be eligible to enroll in the study, subjects must not:
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| Name | Affiliation | Role |
|---|---|---|
| Frank H Lau, MD | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Jefferson Medical Center and LSUHSC-NO | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35638295 | Result | Lau FH, Powell CE, Adonecchi G, Danos DM, DiNardo AR, Chugden RJ, Wolf P, Castilla CF. Pilot phase results of a prospective, randomized controlled trial of narrowband ultraviolet B phototherapy in hospitalized COVID-19 patients. Exp Dermatol. 2022 Jul;31(7):1109-1115. doi: 10.1111/exd.14617. Epub 2022 Jun 13. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D001327 | Autoimmune Diseases |
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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1:1 Randomized Placebo Control Trial
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Double-Blind
| non Narrow Band ultraviolet B-Band Light | Device | Daily doses of non-NB-UVB for 8 consecutive days. |
|
|
| Rate of Stabilization of the Immune Dysregulation (all 3 of These) |
| 28 days |
| Average Reduction in Inflammatory Markers: | HS-CRP (mg/L) | 28 days |
| Average Reduction in Inflammatory Markers: | LDH (units per liter (U/L)) | 28 days |
| Average Reduction in Inflammatory Markers: | Ferritin (micrograms/L) | 28 days |
| Improved Hemostatic Regulation by D-dimer Reduction | D-dimer (ng/mL) | 28 days |
| Improved Hemostatic Regulation by reduce PTT | Partial Thromboplastin Time (PTT) Test | 28 days |
| Average Reduced Viral Load. | Reduced viral load (copies/mL) | 28 days |
| Average and Categorical Increase in Vitamin D: |
i. % of Patients with Improvement from Insufficient (at min. of 18pg/ml); | 28 days |
| % of Patients with a Change in oxygen requirement |
| 28 days |
| Average Temperature |
| 28 days |
| Average Length of Hospitalization | Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization | 28 days |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |