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Covid19NCT04818970

Photo-Protection Trial (NB-UVB vs. Placebo) in High-risk Hospitalized COVID-19 Patients

A study testing Narrow Band ultraviolet B-Band Light and non Narrow Band ultraviolet B-Band Light in people with Covid19 and Corona Virus Infection, run by Cytokind, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 110 years
What is being tested?
Narrow Band ultraviolet B-Band Light and non Narrow Band ultraviolet B-Band Light
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
21 May 2021to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • -
  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • West Jefferson Medical Center and LSUHSC-NO

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Narrow Band ultraviolet B-Band Light, non Narrow Band ultraviolet B-Band Light
Keywords
Narrow Band Ultraviolet Light B-Band, NB-UVB, Immune Dysregulation, Vitamin D
Medical subject headings
COVID-19, Coronavirus Infections, Autoimmune Diseases, Blood Coagulation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrow Band ultraviolet B-Band LightDevice

    Also called Phototherapy

    Daily doses of NB-UVB for 8 consecutive days.

  • non Narrow Band ultraviolet B-Band LightDevice

    Also called Placebo

    Daily doses of non-NB-UVB for 8 consecutive days.

Study groups in NCT04818970
Study groupRoleWhat they receive
Phototherapy of narrow band ultraviolet Light B-Band NB-UVBExperimentalDaavlin Series 1 Phototherapy Unit that emits UVB light between 280nm and 320nm.
Receives: Device: Narrow Band ultraviolet B-Band Light
Placebo - LightPlacebo comparatorDaavlin Series 1 Phototherapy Unit that does not emit UVB light between 280nm and 320 nm.
Receives: Device: non Narrow Band ultraviolet B-Band Light

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality Rate

    % Patient Mortality

    Measured: 14 days

  2. Mortality Rate

    % Patient Mortality

    Measured: 28 days

  3. WHO Ordinal Scale for Clinical Improvement

    Improvement in WHO Ordinal Scale

    Measured: 14 days

  4. WHO Ordinal Scale for Clinical Improvement

    Improvement in WHO Ordinal Scale

    Measured: 28 days

  5. Length of Hospital Stay

    Days from Treatment to Discharge

    Measured: 28 days

  6. Rate of Escalation to the ICU

    % of Patients Escalating to the ICU

    Measured: day 14

  7. Rate of Ventilator Support (intubation) requirement

    % of Patients Requiring Ventilator Support (intubation)

    Measured: day 28

Secondary outcomes (12)

  1. Rate of Improved Immune Regulation as measured by (Any 3 of These):

    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

    Measured: 28 days

  2. Rate of Stabilization of the Immune Dysregulation (all 3 of These)

    1. Decreased Th l and Th 17;
    2. Increased Th2;
    3. Increased circulating regulatory T Cells

    Measured: 28 days

  3. Average Reduction in Inflammatory Markers:

    HS-CRP (mg/L)

    Measured: 28 days

  4. Average Reduction in Inflammatory Markers:

    LDH (units per liter (U/L))

    Measured: 28 days

  5. Average Reduction in Inflammatory Markers:

    Ferritin (micrograms/L)

    Measured: 28 days

  6. Improved Hemostatic Regulation by D-dimer Reduction

    D-dimer (ng/mL)

    Measured: 28 days

  7. Improved Hemostatic Regulation by reduce PTT

    Partial Thromboplastin Time (PTT) Test

    Measured: 28 days

  8. Average Reduced Viral Load.

    Reduced viral load (copies/mL)

    Measured: 28 days

  9. Average and Categorical Increase in Vitamin D:

    1. 25(OH)D hydroxyvitamin D
    2. % of Patients Improving from Critical Deficiency (min. of 20ng/ml); ii. % of Patients Improving from Insufficiency (at min. of 30ng/ml);
    3. Active 1,25-dihydroxyvitamin D and
    4. % of Patients with Improvement from Insufficient (at min. of 18pg/ml);

    Measured: 28 days

  10. % of Patients with a Change in oxygen requirement

    1. Non-invasive positive pressure support (BiPAP \& CPAP)
    2. Discharge from the ICU
    3. Removal from Ventilator Support

    Measured: 28 days

  11. Average Temperature

    1. (Average for each day) - Hospital Staff
    2. (Highest Record of the day) - Hospital Staff

    Measured: 28 days

  12. Average Length of Hospitalization

    Days in the ICU Days to Discharge Need for Rehospitalization Need for COVID Related Rehospitalization

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start21 May 2021
  3. Primary completion31 Oct 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Randomized Placebo Control Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04818970
Sponsor's protocol ID
TPL0001-02
Status last verified
Jun 2022
First submitted
24 Mar 2021
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35638295

Questions about this trial

What is this clinical trial studying?

A study testing Narrow Band ultraviolet B-Band Light and non Narrow Band ultraviolet B-Band Light in people with Covid19 and Corona Virus Infection, run by Cytokind, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality Rate (time frame: 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04818970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.

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