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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
Sponsor:
Collaborators:
Louisiana State University Health Sciences Center in New Orleans
Baylor College of Medicine
West Jefferson Medical Center
Information provided by (Responsible Party):
Cytokind, Inc.

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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 Randomized Placebo Control Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: 14 days ]
    % Patient Mortality

  2. Mortality Rate [ Time Frame: 28 days ]
    % Patient Mortality

  3. WHO Ordinal Scale for Clinical Improvement [ Time Frame: 14 days ]
    Improvement in WHO Ordinal Scale

  4. WHO Ordinal Scale for Clinical Improvement [ Time Frame: 28 days ]
    Improvement in WHO Ordinal Scale

  5. Length of Hospital Stay [ Time Frame: 28 days ]
    Days from Treatment to Discharge

  6. Rate of Escalation to the ICU [ Time Frame: day 14 ]
    % of Patients Escalating to the ICU

  7. Rate of Ventilator Support (intubation) requirement [ Time Frame: day 28 ]
    % of Patients Requiring Ventilator Support (intubation)


Secondary Outcome Measures :
  1. Rate of Improved Immune Regulation as measured by (Any 3 of These): [ Time Frame: 28 days ]
    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

  2. Rate of Stabilization of the Immune Dysregulation (all 3 of These) [ Time Frame: 28 days ]
    1. Decreased Th l and Th 17;
    2. Increased Th2;
    3. Increased circulating regulatory T Cells

  3. Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]
    HS-CRP (mg/L)

  4. Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]
    LDH (units per liter (U/L))

  5. Average Reduction in Inflammatory Markers: [ Time Frame: 28 days ]
    Ferritin (micrograms/L)

  6. Improved Hemostatic Regulation by D-dimer Reduction [ Time Frame: 28 days ]
    D-dimer (ng/mL)

  7. Improved Hemostatic Regulation by reduce PTT [ Time Frame: 28 days ]
    Partial Thromboplastin Time (PTT) Test

  8. Average Reduced Viral Load. [ Time Frame: 28 days ]
    Reduced viral load (copies/mL)

  9. Average and Categorical Increase in Vitamin D: [ Time Frame: 28 days ]
    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);


  10. % of Patients with a Change in oxygen requirement [ Time Frame: 28 days ]
    1. Non-invasive positive pressure support (BiPAP & CPAP)
    2. Discharge from the ICU
    3. Removal from Ventilator Support

  11. Average Temperature [ Time Frame: 28 days ]
    1. (Average for each day) - Hospital Staff
    2. (Highest Record of the day) - Hospital Staff

  12. Average Length of Hospitalization [ Time Frame: 28 days ]
    Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Frank H Lau, MD 504-412-1240 flau@lsuhsc.edu
Contact: Ann D McKendrick, MSW 504-251-3924 amcken@lsuhsc.edu

Locations
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United States, Louisiana
West Jefferson Medical Center and LSUHSC-NO Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Frank H Lau, MD    504-412-1240    flau@lsuhsc.edu   
Contact: Ann D McKendrick, MSW    504-251-3924    amcken@lsuhsc.edu   
Sponsors and Collaborators
Cytokind, Inc.
Louisiana State University Health Sciences Center in New Orleans
Baylor College of Medicine
West Jefferson Medical Center
Investigators
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Principal Investigator: Frank H Lau, MD Louisiana State University Health Sciences Center in New Orleans
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Responsible Party: Cytokind, Inc.
ClinicalTrials.gov Identifier: NCT04818970    
Other Study ID Numbers: TPL0001-02
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Cytokind, Inc.:
Narrow Band Ultraviolet Light B-Band
NB-UVB
Immune Dysregulation
Vitamin D
Additional relevant MeSH terms:
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Coronavirus Infections
Hemostatic Disorders
Blood Coagulation Disorders
Autoimmune Diseases
Virus Diseases
Immune System Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders