Trial Outcomes & Findings for Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19 (NCT NCT04662671)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Baseline thru Day 8

Results posted on

2022-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	RD-X19 Device RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Overall Study STARTED	20	11
Overall Study COMPLETED	20	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RD-X19 Device n=20 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Hispanic or Latino	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	11 participants n=7 Participants	31 participants n=5 Participants
Laboratory Confirmed SARS-CoV-2 at Baseline via RT-PCR (saliva)	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline thru Day 8

Population: Intent-to-Treat

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.

Outcome measures

Outcome measures
Measure	RD-X19 Device n=20 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Primary Safety Measure	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to Day 8

Population: Modified Analysis Set with Laboratory Confirmed SARS-CoV-2 at Baseline via RT-PCR

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

Outcome measures

Outcome measures
Measure	RD-X19 Device n=17 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Primary Efficacy Measure	-1.69 TWAC (SARS-COV-2 N1 Log10 copies/mL) Interval -2.27 to -1.12	-1.23 TWAC (SARS-COV-2 N1 Log10 copies/mL) Interval -1.95 to -0.52

SECONDARY outcome

Timeframe: Days 1, 3, 5 and 8

Population: Modified analysis set for virologic efficacy assessments.

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

Outcome measures

Outcome measures
Measure	RD-X19 Device n=17 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Proportion of Subjects Demonstrating Clearance of Viral Infection	10 Participants	4 Participants

SECONDARY outcome

Timeframe: Daily through day 8

Population: ITT

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).

Outcome measures

Outcome measures
Measure	RD-X19 Device n=20 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Median Time to Alleviation of Symptoms	75.3 hours Interval 48.3 to 117.2	112.7 hours Interval 38.0 to 166.2

POST_HOC outcome

Timeframe: Daily through day 8

Population: ITT

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.

Outcome measures

Outcome measures
Measure	RD-X19 Device n=20 Participants RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 Participants Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Median Time to Sustained Resolution of Symptoms	103.8 hours Interval 69.0 to 130.8	160.7 hours Interval 38.0 to 192.0

Adverse Events

RD-X19 Device

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RD-X19 Device n=20 participants at risk RD-X19: Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.	Sham n=11 participants at risk Sham: The sham devices were designed to provide the same user experience but at energy and fluence levels with a lower inactivation potential against SARS-CoV-2 in vitro than that delivered by the active devices.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	10.0% 2/20 • Number of events 2 • 8 Days	9.1% 1/11 • Number of events 1 • 8 Days
Gastrointestinal disorders Nausea	25.0% 5/20 • Number of events 5 • 8 Days	27.3% 3/11 • Number of events 3 • 8 Days
General disorders Chills	0.00% 0/20 • 8 Days	27.3% 3/11 • Number of events 3 • 8 Days
General disorders Fatigue	10.0% 2/20 • Number of events 2 • 8 Days	18.2% 2/11 • Number of events 2 • 8 Days
Musculoskeletal and connective tissue disorders Myalgia	15.0% 3/20 • Number of events 3 • 8 Days	0.00% 0/11 • 8 Days
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 8 Days	9.1% 1/11 • Number of events 1 • 8 Days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • 8 Days	9.1% 1/11 • Number of events 1 • 8 Days
Respiratory, thoracic and mediastinal disorders Nasal Congestion	25.0% 5/20 • Number of events 5 • 8 Days	18.2% 2/11 • Number of events 2 • 8 Days

Additional Information

Chief Scientific Officer

EmitBio, Inc.

Phone: (919) 321-1734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators are bound by signed Non-confidentiality Agreements and Clinical Trial Agreements with EmitBio, Inc. as the sponsor of this trial.
Publication restrictions are in place

Restriction type: OTHER