Back to resultsPhoto-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
Primary Purpose
Covid19, Corona Virus Infection, Autoimmune Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow Band ultraviolet B-Band Light
non Narrow Band ultraviolet B-Band Light
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Narrow Band Ultraviolet Light B-Band, NB-UVB, Immune Dysregulation, Vitamin D
Eligibility Criteria
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
Sites / Locations
- West Jefferson Medical Center and LSUHSC-NO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Phototherapy of narrow band ultraviolet Light B-Band NB-UVB
Placebo - Light
Arm Description
Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.
Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.
Outcomes
Primary Outcome Measures
Mortality Rate
% Patient Mortality
Mortality Rate
% Patient Mortality
WHO Ordinal Scale for Clinical Improvement
Improvement in WHO Ordinal Scale
WHO Ordinal Scale for Clinical Improvement
Improvement in WHO Ordinal Scale
Length of Hospital Stay
Days from Treatment to Discharge
Rate of Escalation to the ICU
% of Patients Escalating to the ICU
Rate of Ventilator Support (intubation) requirement
% of Patients Requiring Ventilator Support (intubation)
Secondary Outcome Measures
Rate of Improved Immune Regulation as measured by (Any 3 of These):
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)
Decreased Th l and Th 17;
Increased Th2;
Increased circulating regulatory T Cells
Average Reduction in Inflammatory Markers:
HS-CRP (mg/L)
Average Reduction in Inflammatory Markers:
LDH (units per liter (U/L))
Average Reduction in Inflammatory Markers:
Ferritin (micrograms/L)
Improved Hemostatic Regulation by D-dimer Reduction
D-dimer (ng/mL)
Improved Hemostatic Regulation by reduce PTT
Partial Thromboplastin Time (PTT) Test
Average Reduced Viral Load.
Reduced viral load (copies/mL)
Average and Categorical Increase in Vitamin D:
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
Non-invasive positive pressure support (BiPAP & CPAP)
Discharge from the ICU
Removal from Ventilator Support
Average Temperature
(Average for each day) - Hospital Staff
(Highest Record of the day) - Hospital Staff
Average Length of Hospitalization
Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization
Full Information
NCT ID
NCT04818970
First Posted
March 24, 2021
Last Updated
June 13, 2022
Sponsor
Cytokind, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans, Baylor College of Medicine, West Jefferson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04818970
Brief Title
Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokind, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans, Baylor College of Medicine, West Jefferson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corona Virus Infection, Autoimmune Diseases, Coagulation Disorder, Blood
Keywords
Narrow Band Ultraviolet Light B-Band, NB-UVB, Immune Dysregulation, Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Randomized Placebo Control Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phototherapy of narrow band ultraviolet Light B-Band NB-UVB
Arm Type
Experimental
Arm Description
Daavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.
Arm Title
Placebo - Light
Arm Type
Placebo Comparator
Arm Description
Daavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.
Intervention Type
Device
Intervention Name(s)
Narrow Band ultraviolet B-Band Light
Other Intervention Name(s)
Phototherapy
Intervention Description
Daily doses of NB-UVB for 8 consecutive days.
Intervention Type
Device
Intervention Name(s)
non Narrow Band ultraviolet B-Band Light
Other Intervention Name(s)
Placebo
Intervention Description
Daily doses of non-NB-UVB for 8 consecutive days.
Primary Outcome Measure Information:
Title
Mortality Rate
Description
% Patient Mortality
Time Frame
14 days
Title
Mortality Rate
Description
% Patient Mortality
Time Frame
28 days
Title
WHO Ordinal Scale for Clinical Improvement
Description
Improvement in WHO Ordinal Scale
Time Frame
14 days
Title
WHO Ordinal Scale for Clinical Improvement
Description
Improvement in WHO Ordinal Scale
Time Frame
28 days
Title
Length of Hospital Stay
Description
Days from Treatment to Discharge
Time Frame
28 days
Title
Rate of Escalation to the ICU
Description
% of Patients Escalating to the ICU
Time Frame
day 14
Title
Rate of Ventilator Support (intubation) requirement
Description
% of Patients Requiring Ventilator Support (intubation)
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Rate of Improved Immune Regulation as measured by (Any 3 of These):
Description
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
Time Frame
28 days
Title
Rate of Stabilization of the Immune Dysregulation (all 3 of These)
Description
Decreased Th l and Th 17;
Increased Th2;
Increased circulating regulatory T Cells
Time Frame
28 days
Title
Average Reduction in Inflammatory Markers:
Description
HS-CRP (mg/L)
Time Frame
28 days
Title
Average Reduction in Inflammatory Markers:
Description
LDH (units per liter (U/L))
Time Frame
28 days
Title
Average Reduction in Inflammatory Markers:
Description
Ferritin (micrograms/L)
Time Frame
28 days
Title
Improved Hemostatic Regulation by D-dimer Reduction
Description
D-dimer (ng/mL)
Time Frame
28 days
Title
Improved Hemostatic Regulation by reduce PTT
Description
Partial Thromboplastin Time (PTT) Test
Time Frame
28 days
Title
Average Reduced Viral Load.
Description
Reduced viral load (copies/mL)
Time Frame
28 days
Title
Average and Categorical Increase in Vitamin D:
Description
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);
Time Frame
28 days
Title
% of Patients with a Change in oxygen requirement
Description
Non-invasive positive pressure support (BiPAP & CPAP)
Discharge from the ICU
Removal from Ventilator Support
Time Frame
28 days
Title
Average Temperature
Description
(Average for each day) - Hospital Staff
(Highest Record of the day) - Hospital Staff
Time Frame
28 days
Title
Average Length of Hospitalization
Description
Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank H Lau, MD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Jefferson Medical Center and LSUHSC-NO
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35638295
Citation
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.
Results Reference
result
Learn more about this trial
Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
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