Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
May 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 15, 2022
June 1, 2022
5 months
March 24, 2021
June 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Secondary Outcomes (12)
Rate of Improved Immune Regulation as measured by (Any 3 of These):
28 days
Rate of Stabilization of the Immune Dysregulation (all 3 of These)
28 days
Average Reduction in Inflammatory Markers:
28 days
Average Reduction in Inflammatory Markers:
28 days
Average Reduction in Inflammatory Markers:
28 days
- +7 more secondary outcomes
Study Arms (2)
Phototherapy of narrow band ultraviolet Light B-Band NB-UVB
EXPERIMENTALDaavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.
Placebo - Light
PLACEBO COMPARATORDaavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.
Interventions
Daily doses of NB-UVB for 8 consecutive days.
Daily doses of non-NB-UVB for 8 consecutive days.
Eligibility Criteria
You may qualify if:
- To be eligible to enroll in the study, subjects must be:
- In-Hospital
- 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.
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytokind, Inc.lead
- Louisiana State University Health Sciences Center in New Orleanscollaborator
- Baylor College of Medicinecollaborator
- West Jefferson Medical Centercollaborator
Study Sites (1)
West Jefferson Medical Center and LSUHSC-NO
New Orleans, Louisiana, 70112, United States
Related Publications (1)
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.
PMID: 35638295RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank H Lau, MD
Louisiana State University Health Sciences Center in New Orleans
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 26, 2021
Study Start
May 21, 2021
Primary Completion
October 31, 2021
Study Completion
December 1, 2021
Last Updated
June 15, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share