NCT04966013

Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing RD-X19 in COVID19 in 216 participants. Completed in 23 February 2022.

Timeline

17 June 2021

Primary endpoint
5 January 2022

23 February 2022

Quick facts

Lead sponsor	EmitBio Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	216
Start date	17 June 2021
Primary completion	5 January 2022
Estimated completion	23 February 2022
Sites	9 locations across United States

Drugs / interventions tested

• RD-X19
• Sham

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.

Time to Sustained Resolution of COVID-19 Signs and Symptoms in All Subjects (With Mild or Moderate Disease at Baseline). Primary · Baseline thru Day 14

Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to h

Median of Time to Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	113.5	99.3 – 142.5
RD-X19 Device, Cohort A	172.1	115.5 – 223.5
Sham Device	115.1	81.9 – 166.3

25th Percentile of Time to Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	63.8	52.7 – 82.7
RD-X19 Device, Cohort A	91.6	66.0 – 160.7
Sham Device	55.4	42.7 – 81.9

75th Percentile of Time to Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	190.6	164.5 – 246.3
RD-X19 Device, Cohort A	266.3	192.1 – 384
Sham Device	196.6	166.3 – 294.9

Sustained Resolution of COVID-19 Signs and Symptoms in Subjects With Mild Disease at Baseline. Primary · Baseline thru Day 14

Each of eight symptoms (cough, sore throat, nasal congestion, headache, chills and or sweats, myalgia, fatigue, and nausea (with or without vomiting)) will be rated on a 4-point scale from none (0) to severe (3). Time to sustained resolution of COVID-19 signs and symptoms as measured by the time (in hours) when all eight symptoms have been assessed by the subject as none (0) or mild (1) and all symptoms remain at or below 1 until study Day 14. Subjects reporting a persistent fever (100.5 degrees for 36 hours or more) and/or SpO2 levels \<96% with any shortness of breath are considered not to h

Median Time of Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	99.3	72.2 – 119.3
Sham Device	119.5	78.0 – 185.6
RD-X19 Device Cohort A	172.1	101.8 – 223.5

25th Percentile of Time to Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	54.8	45.1 – 72.2
Sham Device	47.9	42.7 – 93.0
RD-X19 Device Cohort A	87.9	66.0 – 160.7

75th Percentile of Time to Sustained Resolution

Group	Value	95% CI
RD-X19 Device, Dose B	164.8	120.3 – 222.3
Sham Device	196.6	144.0 – 322.0
RD-X19 Device Cohort A	254.7	192.1 – 384

Medically Attended Visits Secondary · Baseline thru Day 14

Numbers and percentages of study subjects who require medical attention or intervention attributed to COVID-19;

Group	Value	95% CI
RD-X19 Device, Dose A	5
RD-X19 Device, Dose B	5
Sham Device	2

Severe Disease Progression Secondary · Baseline thru Day 14

Numbers and percentages of study subjects who progress to severe disease with respiratory rate \>30/minute and/or O2 saturation \</=93% on room air or FiO2 ≥300% with any respiratory distress.

Group	Value	95% CI
RD-X19 Device, Dose A	3
RD-X19 Device, Dose B	2
Sham Device	1

Hospitalizations Secondary · Baseline thru Day 14

Numbers and percentages of study subjects who require hospitalization for severe COVID-19.

Group	Value	95% CI
RD-X19 Device, Dose A	4
RD-X19 Device, Dose B	3
Sham Device	2

Worsening of Disease Secondary · Day 3 thru Day 14

Number and percentage of study subjects who experience progression of COVID-19 as defined by an increase of the composite COVID-19 severity score greater than baseline at any point in the study on or after day 3.

Group	Value	95% CI
RD-X19 Device, Dose A	5
RD-X19 Device, Dose B	10
Sham Device	11

Return to Pre-COVID Health Secondary · Days 8 and 14

Numbers and percentages of study subjects on day 8 and day 14 who answer yes to the following patient-reported global impression assessments, a) return to usual health and b) return to usual activities. 1. In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? Yes or No 2. In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)? Yes or No Note: subjects with missing Data at Day 8 or Day 14 were not included in total subjects analyzed

Subjects who returned to usual health on Day 8

Group	Value	95% CI
RD-X19 Device, Dose A	10
RD-X19 Device, Dose B	54
Sham Device	27

Subjects who returned to usual activities on Day 8

Group	Value	95% CI
RD-X19 Device, Dose A	9
RD-X19 Device, Dose B	74
Sham Device	41

Subjects who returned to usual health on Day 14

Group	Value	95% CI
RD-X19 Device, Dose A	17
RD-X19 Device, Dose B	84
Sham Device	49

Subjects who returned to usual activities on Day 14

Group	Value	95% CI
RD-X19 Device, Dose A	16
RD-X19 Device, Dose B	96
Sham Device	56

Mean Change in Nasopharyngeal Viral Load Secondary · Days 3, 5, 8 and 14

Mean change in nasopharyngeal viral load from baseline on days 3, 5, 8, and 14.

Day 3

Group	Value	95% CI
RD-X19 Device, Dose A	-0.849	± 0.8828
RD-X19 Device, Dose B	-1.269	± 1.0666
Sham Device	-0.928	± 1.7048

Day 5

Group	Value	95% CI
RD-X19 Device, Dose A	-2.218	± 0.9273
RD-X19 Device, Dose B	-2.649	± 1.6975
Sham Device	-2.107	± 1.9003

Day 8

Group	Value	95% CI
RD-X19 Device, Dose A	-3.663	± 1.8057
RD-X19 Device, Dose B	-4.132	± 1.9791
Sham Device	-3.744	± 1.8545

Day 14

Group	Value	95% CI
RD-X19 Device, Dose A	-4.827	± 1.6769
RD-X19 Device, Dose B	-5.584	± 1.5876
Sham Device	-5.084	± 2.1024

Proportion of Subjects Demonstrating Clearance of Viral Infection Secondary · Days 3, 5, 8 and 14

Proportion of subjects demonstrating clearance of viral infection on Days 3, 5, 8 and 14.

Day 3

Group	Value	95% CI
RD-X19 Device, Dose A	0
RD-X19 Device, Dose B	2
Sham Device	4

Day 5

Group	Value	95% CI
RD-X19 Device, Dose A	0
RD-X19 Device, Dose B	15
Sham Device	6

Day 8

Group	Value	95% CI
RD-X19 Device, Dose A	1
RD-X19 Device, Dose B	34
Sham Device	19

Day 14

Group	Value	95% CI
RD-X19 Device, Dose A	2
RD-X19 Device, Dose B	68
Sham Device	34

Day 8 Composite Resolution Secondary · Baseline thru Day 8

Proportion of study subjects who achieve Day 8 Composite Resolution.

Group	Value	95% CI
RD-X19 Device, Dose A	14
RD-X19 Device, Dose B	81
Sham Device	48

Endotracheal Ventilation or ECMO Secondary · Baseline thru Day 14

Number and percentage of study subjects who require endotracheal ventilation or ECMO with or without the use of solumedrol.

Group	Value	95% CI
RD-X19 Device, Dose A	0
RD-X19 Device, Dose B	0
Sham Device	0

Death Secondary · Baseline thru Day 14

Number and percentage of study subjects who die.

Group	Value	95% CI
RD-X19 Device, Dose A	0
RD-X19 Device, Dose B	0
Sham Device	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Through day 14 (±2 days). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RD-X19 Device, Dose A

Serious: 4/28 (14%)

Deaths: 0/28

RD-X19 Device, Dose B

Serious: 3/117 (3%)

Deaths: 0/117

Sham Device

Serious: 2/71 (3%)

Deaths: 0/71

Serious adverse events (2 terms)

Reaction	System	RD-X19 Device, Dose A	RD-X19 Device, Dose B	Sham Device
Covid-19 Pneumonia	Infections and infestations	—	—	—
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	RD-X19 Device, Dose A	RD-X19 Device, Dose B	Sham Device
Nausea	Gastrointestinal disorders	—	—	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Chills	General disorders	—	—	—
Neutrophil/Lymphocyte Ratio Increased	Investigations	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Covid-19 Pneumonia	Infections and infestations	—	—	—
Administrative Site Pain	General disorders	—	—	—
Red Cell Distribution Width Increased	Investigations	—	—	—
Toothache	Gastrointestinal disorders	—	—	—
Chest Pain	General disorders	—	—	—
Malaise	General disorders	—	—	—
Sepsis	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Jaw Clicking	Musculoskeletal and connective tissue disorders	—	—	—
Muscle Spasm	Musculoskeletal and connective tissue disorders	—	—	—
Pain in Jaw	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Covid-19 Pneumonia, Acute Respiratory Failure.

Data from ClinicalTrials.gov NCT04966013 adverse events section.

Sponsor's own description

This is a randomized, sham controlled, dose finding study of the EmitBio RD-X19 device in individuals with symptomatic COVID-19 in the outpatient setting.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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