NCT04662671

Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19

Completed NA Results posted Last updated 8 September 2022

What this trial tests

NA trial testing RD-X19 in COVID19 in 31 participants. Completed in 30 January 2021.

Timeline

18 November 2020

Primary endpoint
9 December 2020

30 January 2021

Quick facts

Lead sponsor	EmitBio Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	31
Start date	18 November 2020
Primary completion	9 December 2020
Estimated completion	30 January 2021
Sites	2 locations across United States

Drugs / interventions tested

• RD-X19

Conditions studied

• COVID19 — all drugs for COVID19 →

Sponsor

EmitBio Inc.

Who can join

Adults 18 to 65, any sex, with COVID19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Safety Measure Primary · Baseline thru Day 8

Number of Participants with device-related serious adverse events or any patterns of severity ≥2 device-related adverse events in the same SOC grouping of Preferred Terms based on Medical Dictionary for Regulatory Activities (MedDRA) coding, as determined throughout the course of the study.

Group	Value	95% CI
RD-X19 Device	0
Sham	0

Primary Efficacy Measure Primary · Baseline to Day 8

Time weighted average change in viral load from baseline by RT-qPCR from Day 1 to Day 8.

Group	Value	95% CI
RD-X19 Device	-1.69	-2.27 – -1.12
Sham	-1.23	-1.95 – -0.52

Proportion of Subjects Demonstrating Clearance of Viral Infection Secondary · Days 1, 3, 5 and 8

Proportion of subjects demonstrating clearance of viral infection, defined as a negative test via RT-qPCR on Day 8/ET.

Group	Value	95% CI
RD-X19 Device	10
Sham Device	4

Median Time to Alleviation of Symptoms Secondary · Daily through day 8

Median time to alleviation of symptoms as measured by the time when all eight symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) had been assessed by the subject as none (0) or mild (1).

Group	Value	95% CI
RD-X19 Device	75.3	48.3 – 117.2
Sham	112.7	38.0 – 166.2

Median Time to Sustained Resolution of Symptoms Secondary · Daily through day 8

Median time to Sustained Resolution of Symptoms as measured by the time when all eight symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle or joint pain, fatigue, and nausea) had been assessed by the subject as none (0) or mild (1) without rebound of any score greater than 1 for the remainder of the trial.

Group	Value	95% CI
RD-X19 Device	103.8	69.0 – 130.8
Sham	160.7	38.0 – 192

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RD-X19 Device

Serious: 0/20 (0%)

Deaths: 0/20

Sham

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (8 terms — click to expand)

Reaction	System	RD-X19 Device	Sham
Nausea	Gastrointestinal disorders	—	—
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—	—
Chills	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—
Fatigue	General disorders	—	—
Headache	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT04662671 adverse events section.

Sponsor's own description

This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized, controlled, feasibility study of RD-X19 in subjects with mild-to-moderate COVID-19 in the outpatient setting.
   Stasko N, Cockrell AS, Kocher JF, Henson I, et al · · 2022 · cited 5× · PMID 35137532 · DOI 10.1111/cts.13249
2. A randomized, controlled, feasibility study of RD-X19 in patients with mild-to-moderate COVID-19 in the outpatient setting
   Stasko N, Cockrell AS, Kocher JF, Henson I, et al · · 2021 · cited 2× · DOI 10.1101/2021.10.17.21265058
3. The pan-variant potential of light: 425 nm light inactivates SARS-CoV-2 variants of concern and non-cytotoxic doses reduce viral titers in human airway epithelial cells.
   Stasko N, Arwood L, Jandick N, Spragion D, et al · · 2025 · PMID 40434113 · DOI 10.1128/msphere.00230-25