40 and older, any sex, with COVID-19. 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.
Number of Subjects With Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study)Primary· Baseline through 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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14. A subject not satisfying c
Group
Value
95% CI
Active
107
Sham
120
Kaplan-Meier Estimates for Time to Sustained Resolution of COVID-19 Signs and Symptoms Without Subsequent Symptom Recurrence or Disease Progression (Until the End of the Study) Full Analysis Set (FAS)Primary· Baseline through 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 that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisf
25th percentile for time to sustained resolution
Group
Value
95% CI
Active
44.22
26.628 – 64.440
Sham
62.49
41.338 – 70.551
Median time to sustained resolution
Group
Value
95% CI
Active
100.36
80.264 – 137.830
Sham
113.39
89.617 – 140.690
75th percentile for time to sustained resolution
Group
Value
95% CI
Active
NA
209.970 – NA
Sham
261.35
205.188 – NA
Number of Subjects With Two Negative SARS-CoV-2 Antigen Tests (With a Minimum Time Between Tests of Six Hours) Without Subsequent Virological Rebound During the Subject's Remaining Time on StudySecondary· Baseline through Day 14
Number of subjects with two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound during the subject's remaining time on study. Subjects that are hospitalized will be censored at 360 hours, which corresponds to the end of the time window for the day 14 visit. A subject not satisfying case (i) or (ii), who takes nirmatrelvir/ritonavir or molnupiravir after initiating study treatment will be censored at the time that they first took this antiviral medication. Subjects not satisfying case (i), (ii), or (iii) will be censored at t
Group
Value
95% CI
Active
146
Sham
157
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen TestsSecondary· Baseline through Day 14
time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)
25th percentile for time to first of two negative SARS-CoV-2 tests
Group
Value
95% CI
Active
47.02
41.241 – 60.457
Sham
52.89
40.966 – 66.051
Median time to first of two negative SARS-CoV-2 tests
Group
Value
95% CI
Active
74.58
70.741 – 87.604
Sham
87.97
75.473 – 96.581
75th percentile for time to first of two negative SARS-CoV-2 tests
Group
Value
95% CI
Active
111.18
100.228 – 121.916
Sham
133.42
114.496 – 144.960
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)Secondary· Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit
The following are secondary qualitative measures (each taking the values yes, no) recorded at the post-baseline clinic visits for COVID-related assessment:
In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)? In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?
Returned to usual health in past 24 hours (Day 5 visit)
Group
Value
95% CI
Active
48
Sham
48
Active
96
Sham
108
Active
1
Sham
2
Returned to usual health in past 24 hours (Day 8 visit)
Group
Value
95% CI
Active
97
Sham
100
Active
46
Sham
54
Active
4
Sham
4
Returned to usual health in past 24 hours (Day 14/ET visit)
Group
Value
95% CI
Active
129
Sham
132
Active
23
Sham
22
Active
2
Sham
4
Returned to usual activities in past 24 hours (Day 5 visit)
Group
Value
95% CI
Active
67
Sham
71
Active
77
Sham
85
Active
1
Sham
2
Returned to usual activities in past 24 hours (Day 8 visit)
Group
Value
95% CI
Active
115
Sham
115
Active
28
Sham
38
Active
4
Sham
5
Returned to usual activities in past 24 hours (Day 14/ET visit)
Group
Value
95% CI
Active
137
Sham
138
Active
15
Sham
16
Active
2
Sham
4
Adverse events — posted to ClinicalTrials.gov
Time frame: 14 days.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 treatment device in Individuals 40 Years of age and older with Mild COVID-19 in the at-home setting.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04966013 — Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
· NA
· completed
NCT04662671 — Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19
· NA
· completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults
· Phase 1
· active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
· Phase 3
· active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
· Phase 1
· recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
Other EmitBio Inc. trials
Trials by the same sponsor.
NCT06113679 — Pilot Randomized Study of RD-X19 Tx Device in Subjects With PCC (Long Covid) in the Outpatient Setting
· NA
· terminated
NCT04966013 — Evaluation of the RD-X19 Treatment Device in Individuals With Mild to Moderate COVID-19
· NA
· completed
NCT04662671 — Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19
· NA
· completed
NCT04557826 — Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EmitBio Inc.
Last refreshed: 24 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05817045.