Trial Outcomes & Findings for Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis (NCT NCT05180500)
NCT ID: NCT05180500
Last Updated: 2024-04-23
Results Overview
Number of participants with Grade 2 or higher adverse events deemed related to study product
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Approximately 8 weeks
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
Q-GRFT Nasal Spray
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
17
|
|
Overall Study
COMPLETED
|
30
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Q-GRFT Nasal Spray
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Baseline characteristics by cohort
| Measure |
Q-GRFT Nasal Spray
n=33 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
27.6 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
28.1 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Nonbinary
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transgender male to female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
17 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
COVID-19 Diagnosis
Yes
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
COVID-19 Diagnosis
No
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: All participants randomized to study product are included in this analysis.
Number of participants with Grade 2 or higher adverse events deemed related to study product
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=33 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Number of Participants With Related Grade 2 or Higher Adverse Events
Participants with related Grade 2 or higher
|
6 Participants
|
2 Participants
|
|
Number of Participants With Related Grade 2 or Higher Adverse Events
Participants without related Grade 2 or higher
|
27 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Approximately 24 hoursPopulation: All participants on whom a nasopharyngeal swab was collected 24 hours after intranasal application of a single dose of study product.
Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after intranasal application of a single dose of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=31 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours
|
1007 ng/mL
Interval to 1740.0
Q-GRFT levels in 12 of 31 (39%) nasopharyngeal samples were below the limit of quantitation for the assay which was 15 ng/mL
|
NA ng/mL
Q-GRFT levels in all nasopharyngeal samples were below the limit of quantitation for the assay which was 15 ng/mL
|
SECONDARY outcome
Timeframe: 24 hours after final dose of study productPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
Q-GRFT concentration in plasma collected 24 hours after the final intranasal application of 13 consecutive once daily administrations of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
|
NA ng/mL
Q-GRFT levels in all plasma samples were below the limit of quantitation for the assay which was 3ng/mL
|
NA ng/mL
Q-GRFT levels in all plasma samples were below the limit of quantitation for the assay which was 3ng/mL
|
SECONDARY outcome
Timeframe: Approximately 28 daysPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
Area under the plasma concentration versus time curve of Q-GRFT collected after 13 consecutive daily intranasal applications of study product. Q-GRFT concentrations will be measured prior to the first application of study product and at 7-days, 14-days, and 28-days after the first of thirteen daily applications of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve of Q-GRFT
|
NA ng x day/mL
Q-GRFT levels in all plasma samples at all time points were below the limit of quantitation for the assay which was 3ng/mL
|
NA ng x day/mL
Q-GRFT levels in all plasma samples at all time points were below the limit of quantitation for the assay which was 3ng/mL
|
SECONDARY outcome
Timeframe: Approximately 14 daysPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
The acceptability of the nasal spray for use at home by the participant if it could protect against infection from coronavirus/COVID-19 will be assessed on a 5-point Likert scale, with 1 being completely unacceptable and 5 being highly acceptable. Acceptability will be assessed approximately 24 hours after the final application of 13 consecutive daily applications of the study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Acceptability of the Intranasal Spray
Acceptable (Highly or somewhat)
|
26 Participants
|
17 Participants
|
|
Acceptability of the Intranasal Spray
Unacceptable (Completely, somewhat, or neutral)
|
4 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 14 daysPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
Mean change in Brief Smell Identification Test (BSIT) score between the score measured before the first application of study product and measured after 13 consecutive daily applications. The BSIT score is the number of odors that a participant correctly recognizes, ranging from 0 to 12. A negative value in the change score indicates a decrease in BSIT score from the pre-dose measurement, while a positive value indicates an increase in BSIT score.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Mean Change in Brief Smell Identification Test (BSIT) Score
|
-0.40 score on a scale
Standard Deviation 1.10
|
-0.24 score on a scale
Standard Deviation 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 24 hoursPopulation: All participants on whom a nares swab was collected 24 hours after intranasal application of a single dose of study product.
Q-GRFT concentration from nares swab eluent collected 24 hours after intranasal application of a single dose of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=31 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours
|
1488 ng/mL
Interval to 6333.0
Q-GRFT levels in 12 of 31 (39%) nares samples were below the limit of quantitation for the assay which was 15 ng/mL
|
NA ng/mL
Q-GRFT levels in all nares samples were below the limit of quantitation for the assay which was 15 ng/mL
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 14 daysPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
|
974 ng/mL
Interval to 2096.0
Q-GRFT levels in 8 of 30 (27%) nasopharyngeal samples were below the limit of quantitation for the assay which was 15 ng/mL
|
NA ng/mL
Q-GRFT levels in all nasopharyngeal samples were below the limit of quantitation for the assay which was 15 ng/mL
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 14 daysPopulation: The 3 participants in the Q-GRFT arm that withdrew from the study were excluded.
Q-GRFT concentration from nares swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=30 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
|
1586 ng/mL
Interval to 3214.0
Q-GRFT levels in 10 of 30 (33%) nares samples were below the limit of quantitation for the assay which was 15 ng/mL
|
NA ng/mL
Q-GRFT levels in all nares samples were below the limit of quantitation for the assay which was 15 ng/mL
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 14 daysPopulation: Twenty out of 50 participants consented to provide a rectal swab sample.
Q-GRFT concentration from rectal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product.
Outcome measures
| Measure |
Q-GRFT Nasal Spray
n=14 Participants
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=6 Participants
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Q-GRFT Concentration From Rectal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
|
106.7 ng/mL
Interval 18.3 to 510.2
|
3.4 ng/mL
Interval 3.0 to 3.8
|
Adverse Events
Q-GRFT Nasal Spray
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Q-GRFT Nasal Spray
n=33 participants at risk
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Q-Griffithsin: Q-Griffithsin is derived from Griffithsin (GRFT) which is a non-glycosylated protein consisting of 121 amino acids. Q-GRFT contains a single amino acid substitution, M78Q variant, resistant to oxidation yet maintains the parent molecule's pharmacological profile.
|
Placebo Nasal Spray
n=17 participants at risk
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.
Placebo: A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
66.7%
22/33 • Number of events 29 • Approximately 8 weeks.
|
35.3%
6/17 • Number of events 7 • Approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Irritation
|
45.5%
15/33 • Number of events 18 • Approximately 8 weeks.
|
47.1%
8/17 • Number of events 8 • Approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
33.3%
11/33 • Number of events 12 • Approximately 8 weeks.
|
41.2%
7/17 • Number of events 7 • Approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Increased Sneezing
|
39.4%
13/33 • Number of events 13 • Approximately 8 weeks.
|
0.00%
0/17 • Approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Edematous Nasal Turbinates
|
21.2%
7/33 • Number of events 8 • Approximately 8 weeks.
|
11.8%
2/17 • Number of events 2 • Approximately 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Blood on Nasopharyngeal Swab
|
9.1%
3/33 • Number of events 3 • Approximately 8 weeks.
|
17.6%
3/17 • Number of events 3 • Approximately 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place