COVID-19
Conditions
Brief summary
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.
Detailed description
This is a randomized, double-blind, sham controlled, stratified, pivotal efficacy and safety study of the EmitBio RD-X19 device in individuals age 40 and older with mild COVID-19 (as defined by NIH and FDA) in the at-home setting. Study subjects will self-administer treatment twice daily, 5 minutes per treatment for 7 consecutive days. Subjects will remain on study for a total of 14 study days (± 2 days) for treatment and follow-up. Neither study subject nor clinical trial personnel will be aware of the subject's treatment assignment. Clinical safety and efficacy outcomes will be assessed via self-assessed signs and symptoms (e-diary entries twice a day during the entire study period) with daily study staff checks, including home visits, and/or clinic visits for objective clinical assessments (vital signs, targeted physical exams, oropharyngeal exams) on study days 1, 5, 8 and 14. The primary goal of the study is to evaluate the safety and efficacy of the RD-X19 treatment device to provide sufficient evidence to FDA to justify the authorization and/or approval of the device for treatment of subjects with mild COVID-19, age 40 and older in the home setting. Every attempt will be made to continue to follow safety in any study subject choosing to terminate the study early and all study subjects who progress to moderate or more severe forms of COVID-19 will be immediately referred for appropriate medical care. Medically necessary care of study participants will always take precedence over research.
Interventions
DEVICERD-X19
Investigational device that uses safe electromagnetic energy to target the oropharynx.
DEVICESham
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV-2 in vitro.
Sponsors
EmitBio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Volunteers meeting all inclusion criteria and none of the exclusion criteria will be randomized to the RD-X19 treatment arm or the sham treatment arm within each cohort in a 1:1 ratio according to a fixed schedule via a permuted block design.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Positive for SARS-CoV-2 as detected using an FDA authorized SARS-CoV-2 antigen test at the screening/baseline visit. 2. Negative for Influenza A and B antigen using an FDA-authorized rapid diagnostic test. 3. At least two moderate or greater COVID-19 signs and symptoms from the following list: cough, sore throat, nasal congestion, headache, chills and/or sweats, myalgia, fatigue, nausea (with or without vomiting) or one moderate or greater symptom and fever (temperature ≥ 100.5 degrees F). 4. Time from appearance of first COVID-19 sign or symptom to screening must be 72 hours or less. 5. Males or females, including pregnant and fecund females, 40 years of age and older on the date of enrollment. 6. BMI \<40 7. Provides written informed consent prior to initiation of any study procedures. 8. Be able to understand and agrees to fully comply with defined and described study procedures and be available for all study visits for the entire study duration. 9. Agrees to collection of a nasopharyngeal swab for qPCR at baseline for the purposes of assessing viral burden as a potential covariate in data analyses and for genetic sequencing to characterize the predominant SARS-CoV-2 variants present in the study population. 10. Agrees to perform self-diagnostic home testing twice a day, separated by ≥ 6 hours for the entire length of the study. 11. Agrees to restrict medications used for symptomatic relief of signs and symptoms of COVID-19 during the study period, and, if used, to report ALL such medications (including home remedies) to the study staff. 12. Agrees to avoid the use of oral rinses and toothpastes containing alcohol-based compounds (e.g. Eucalyptol, Menthol, Thymol, Phenol) and/or Salicylates during the study period. Oral rinses, breath fresheners and toothpaste not containing these compounds are allowed. 13. Agrees to avoid nasal and sinus saline lavage during the study period. 14. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and symptoms (See section 8.1.1 - General Screening)\*. 15. No physical or mental conditions or attributes at the time of screening, which in the opinion of the PI, will prevent full adherence to, and completion of, the protocol.
Exclusion criteria
1. Positive for Influenza A and B antigen using an FDA-authorized rapid diagnostic test. 2. Individuals \< age 40 on study day 1. 3. Individuals who are symptomatic for COVID-19 for more than 72 hours on study day 1. 4. COVID-19 signs associated with moderate or greater disease with evidence of lower respiratory involvement including shortness of breath (SOB) at rest or as determined by an exertional SOB protocol, SpO2 ≤94, respiratory rate ≥20 breaths per minute, heart rate ≥90 beats per minute, or abnormal pulmonary imaging. 5. Any medical disease or condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation. 6. History of use of a rescue inhaler for uncontrolled asthma within one month of study day 1. 7. History of recurrent alcohol intoxication or other recreational drug use (excluding medically prescribed cannabis) within one month of study day 1. 8. History of use, within one month of study day 1, of any FDA-authorized treatment for COVID-19. Use of non-approved putative therapies for COVID-19 (hyroxycholorquine, ivermectin, azithromycin) must be discontinued prior to enrollment in the study. 9. History of any systemic antiviral therapies within one month of study day 1. 10. History of oral or parenteral corticosteroid use within one month of study day 1. Active use of nasal or inhalable steroids is also exclusionary. Topical steroids are not exclusionary. 11. History of any chronic medical condition that has required adjustments to the type, dose or schedule of medical treatments within one month of study day 1. 12. Requirement to use narcotic medication for analgesia. 13. History of vasomotor rhinitis with or without post-nasal drip within one month of study day 1. 14. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to sun exposure. 15. Presence of any oral abnormality (e.g., including, but not limited to, ulcer, oral candidiasis, oral mucositis, symptomatic gingivitis, history of frequent recurrent aphthous ulcers, burning mouth syndrome, dry mouth syndrome, a disease that can result in xerostomia (e.g., Sjogren's syndrome), Temporomandibular Joint Syndrome, or other oral disorder that in the opinion of the investigator would interfere with device use and evaluation. 16. Any intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece. 17. Any individual without teeth or with a dental malformation that precludes directed use of the device as intended. 18. Currently enrolled in or plans to participate in another clinical trial with a therapeutic investigational agent for any medical indication that will be received during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 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 the last time that they have e-diary data recorded. |
| 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) | 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 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 the last time that they have e-diary data recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 the last time that they have e-diary data recorded |
| Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | 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)? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active RD-X19 Active Device
Investigational device that uses 32 J/cm2 of electromagnetic energy to target the oropharynx. | 161 |
| Sham RD-X19 Sham Device
Investigational device that uses safe electromagnetic energy to target the oropharynx but at energy levels with a lower inactivation potential against SARS-CoV2 in vitro. | 166 |
| Total | 327 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device Deficiency | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | System Error | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 7 |
Baseline characteristics
| Characteristic | Sham | Total | Active |
|---|---|---|---|
| Age, Continuous | 55.56 years STANDARD_DEVIATION 10.18 | 54.98 years STANDARD_DEVIATION 9.526 | 54.39 years STANDARD_DEVIATION 8.793 |
| Baseline Log10 nasopharyngeal viral load | 6.2655 log 10 copies/mL STANDARD_DEVIATION 1.53496 | 6.2592 log 10 copies/mL STANDARD_DEVIATION 1.48778 | 6.2527 log 10 copies/mL STANDARD_DEVIATION 1.44278 |
| Baseline Risk Factor Score 0 | 109 Participants | 209 Participants | 100 Participants |
| Baseline Risk Factor Score 1 | 33 Participants | 77 Participants | 44 Participants |
| Baseline Risk Factor Score 2 | 19 Participants | 33 Participants | 14 Participants |
| Baseline Risk Factor Score 3 | 3 Participants | 6 Participants | 3 Participants |
| Baseline Risk Factor Score 4 | 2 Participants | 2 Participants | 0 Participants |
| Baseline Risk Factor Score 5 | 0 Participants | 0 Participants | 0 Participants |
| Baseline Risk Factor Score 6 | 0 Participants | 0 Participants | 0 Participants |
| Baseline Risk Factor Score >6 | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index (BMI) | 29.5443 Kg/m^2 STANDARD_DEVIATION 4.92951 | 29.2525 Kg/m^2 STANDARD_DEVIATION 4.97137 | 28.9498 Kg/m^2 STANDARD_DEVIATION 5.01187 |
| COVID-19 vaccination status Missing | 3 Participants | 4 Participants | 1 Participants |
| COVID-19 vaccination status No | 45 Participants | 83 Participants | 38 Participants |
| COVID-19 vaccination status Yes | 118 Participants | 240 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants | 98 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 224 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Hours at screening since onset of first COVID-19 sign or symptoms | 40.8 hours STANDARD_DEVIATION 15.09 | 42.3 hours STANDARD_DEVIATION 14.8 | 43.9 hours STANDARD_DEVIATION 14.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 72 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 117 Participants | 229 Participants | 112 Participants |
| Randomization Stratum Age 40-49, Disease Severity Score < 1.25 | 10 Participants | 19 Participants | 9 Participants |
| Randomization Stratum Age 40-49, Disease Severity Score >= 1.25 | 45 Participants | 89 Participants | 44 Participants |
| Randomization Stratum Age >= 50, Disease Severity Score < 1.25 | 35 Participants | 70 Participants | 35 Participants |
| Randomization Stratum Age >= 50, Disease Severity Score >= 1.25 | 76 Participants | 149 Participants | 73 Participants |
| Region of Enrollment United States | 166 participants | 327 participants | 161 participants |
| SARS-CoV-2 antigen test type BinaxNOW | 73 Participants | 148 Participants | 75 Participants |
| SARS-CoV-2 antigen test type Flowflex | 93 Participants | 179 Participants | 86 Participants |
| Sex: Female, Male Female | 105 Participants | 204 Participants | 99 Participants |
| Sex: Female, Male Male | 61 Participants | 123 Participants | 62 Participants |
| Total Baseline Disease Severity Score | 1.4571 units on a scale STANDARD_DEVIATION 0.45741 | 1.4771 units on a scale STANDARD_DEVIATION 0.46209 | 1.4977 units on a scale STANDARD_DEVIATION 0.46739 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 162 |
| other Total, other adverse events | 18 / 158 | 12 / 162 |
| serious Total, serious adverse events | 0 / 158 | 0 / 162 |
Outcome results
Primary
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)
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 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 the last time that they have e-diary data recorded.
Time frame: Baseline through Day 14
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active | 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) | 25th percentile for time to sustained resolution | 44.22 hours |
| Active | 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) | Median time to sustained resolution | 100.36 hours |
| Active | 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) | 75th percentile for time to sustained resolution | NA hours |
| Sham | 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) | 25th percentile for time to sustained resolution | 62.49 hours |
| Sham | 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) | Median time to sustained resolution | 113.39 hours |
| Sham | 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) | 75th percentile for time to sustained resolution | 261.35 hours |
Primary
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)
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 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 the last time that they have e-diary data recorded.
Time frame: Baseline through Day 14
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | 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) | 107 Participants |
| Sham | 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) | 120 Participants |
Comparison: NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)p-value: 0.94895% CI: [0.777, 1.31]NPANCOVA
Comparison: NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Populationp-value: 0.90295% CI: [0.774, 1.337]NPANCOVA
Comparison: NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)p-value: 0.85995% CI: [0.782, 1.342]NPANCOVA
Secondary
Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests
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)
Time frame: Baseline through Day 14
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | 25th percentile for time to first of two negative SARS-CoV-2 tests | 47.02 hours |
| Active | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | Median time to first of two negative SARS-CoV-2 tests | 74.58 hours |
| Active | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | 75th percentile for time to first of two negative SARS-CoV-2 tests | 111.18 hours |
| Sham | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | 25th percentile for time to first of two negative SARS-CoV-2 tests | 52.89 hours |
| Sham | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | Median time to first of two negative SARS-CoV-2 tests | 87.97 hours |
| Sham | Kaplan-Meier Estimates Time to First of Two Negative SARS-CoV-2 Antigen Tests | 75th percentile for time to first of two negative SARS-CoV-2 tests | 133.42 hours |
Secondary
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
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 the last time that they have e-diary data recorded
Time frame: Baseline through Day 14
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | 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 | 146 Participants |
| Sham | 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 | 157 Participants |
Comparison: NPANCOVA analysis for 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)p-value: 0.01795% CI: [1.047, 1.596]NPANCOVA
Comparison: NPANCOVA analysis for time to first of 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) (Per-Protocol population)p-value: 0.01495% CI: [1.059, 1.665]NPANCOVA
Comparison: NPANCOVA analysis for time to first of 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) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)p-value: 0.00795% CI: [1.086, 1.69]NPANCOVA
Comparison: Cox proportional hazards model for time to first of 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) (FAS)95% CI: [1.064, 1.997]
Comparison: Subgroup Analysis - Cox proportional hazards model for time to first of 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) (FAS)95% CI: [0.801, 1.561]
Other Pre-specified
Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set)
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)?
Time frame: Baseline, Day 5, Day 8, and Day 14 or Early Termination Visit
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | Yes | 48 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | No | 96 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | Missing | 1 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | Yes | 97 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | No | 46 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | Missing | 4 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | Yes | 129 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | No | 23 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | Missing | 2 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | Yes | 67 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | No | 77 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | Missing | 1 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | Yes | 115 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | No | 28 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | Missing | 4 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | Yes | 137 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | No | 15 Participants |
| Active | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | Missing | 2 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | No | 38 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | Yes | 48 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | Yes | 71 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | No | 108 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | Missing | 4 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 5 visit) | Missing | 2 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | No | 85 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | Yes | 100 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | Missing | 5 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | No | 54 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 5 visit) | Missing | 2 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 8 visit) | Missing | 4 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | No | 16 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | Yes | 132 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 8 visit) | Yes | 115 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | No | 22 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual activities in past 24 hours (Day 14/ET visit) | Yes | 138 Participants |
| Sham | Secondary Qualitative Measures: COVID-19-related Assessment at Baseline, Day 5, 8 and 14/ET Visits (Full Analysis Set) | Returned to usual health in past 24 hours (Day 14/ET visit) | Missing | 4 Participants |