Pilot phase results of a prospective, randomized controlled trial of narrowband ultraviolet B phototherapy in hospitalized COVID-19 patients

Frank H Lau, Catherine E Powell, Giacomo Adonecchi, Denise M Danos, Andrew R DiNardo, Robert J Chugden, Peter Wolf, Carmen F Castilla, Frank H Lau, Catherine E Powell, Giacomo Adonecchi, Denise M Danos, Andrew R DiNardo, Robert J Chugden, Peter Wolf, Carmen F Castilla

Abstract

COVID-19 morbidity and mortality are driven by poor immune regulation. Narrowband ultraviolet B (NB-UVB) phototherapy is standard of care in a number of immune-dysregulated diseases. To assess the efficacy of NB-UVB phototherapy for improving COVID-19 outcomes in high-risk, hospitalized, we developed the Adaptive Photo-Protection Trial. This is a multi-center, prospective, double-blinded, randomized, placebo-controlled trial. The pilot phase results are reported here. Consecutive patients admitted with a positive COVID-19 PCR were screened for eligibility. Enrolled subjects were computer randomized 1:1 to NB-UVB or placebo phototherapy. Subjects were treated daily with escalating doses on 27% of their body surface area for up to 8 consecutive days. Primary outcomes were safety and efficacy, defined as persistent or painful erythema and 28-day mortality. Comparisons were made via non-parametric exact tests. Patients in treatment (n = 15) and placebo (n = 15) arms had similar demographics. No adverse events occurred. Twenty eight-day mortality was 13.3% in treatment vs. 33.3% in placebo arms (p = 0.39). NB-UVB phototherapy in hospitalized COVID-19 patients was safe. Decreased mortality was observed in treated patients but this was statistically non-significant. Given its low-cost, scalability, and adjunctive nature, NB-UVB has the potential to improve COVID-19 outcomes. Continuation of this trial is warranted.

Trial registration: ClinicalTrials.gov NCT04818970.

Keywords: 28-day mortality; COVID-19 outcomes; narrowband ultraviolet B band; phototherapy; randomized trial.

Conflict of interest statement

Carmen F. Castilla, MD is a consultant to the sponsor. No other authors have a conflict to disclose. The sponsor provided the initial design of the trial and provided clinical and technical support on the phototherapy treatment equipment and regimen. The sponsor had no role in the conduct of the study; collection, management, analysis, and interpretation of the data.

© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
CONSORT diagram for the pilot phase of the adaptive photo‐protection trial of the impact of narrowband ultraviolet B band (NB‐UVB) Phototherapy in high‐risk hospitalized COVID‐19 patients
FIGURE 2
FIGURE 2
Mortality at 28 days in the pilot phase of the adaptive photo‐protection trial of the impact of narrowband ultraviolet B band (NB‐UVB) Phototherapy in high‐risk hospitalized COVID‐19 patients

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