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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30CA047904-32S5 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a phase I randomized, placebo-controlled, single site to assess the local and systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray) resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into the placebo arm. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl total) of the participant on the day of enrollment. Participants will be monitored in the clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and acceptable, a second period of daily administration by the participant for 13 days will commence. Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation of the second period. The expected duration of study participation for each participant will be approximately 6-8 weeks. The primary endpoint is the proportion of participants who experience a related Grade 2 or higher adverse event. Secondary and exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability and the impact of Q-GRFT nasal spray on smell.
This is a phase 1 study for intranasal application of Q-Griffithsin (Q-GRFT) spray as a prophylactic for severe acute respiratory syndrome-CoV-2. This randomized, placebo-controlled, single site will assess the local and systemic safety of intranasal Q-GRFT after 14 doses in approximately 45 adult participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray) resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into the placebo arm. Accrual of approximately 45 evaluable participants is expected to take 6 months. The expected duration of study participation for each participant will be approximately 6-8 weeks. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl total) of the participant on the day of enrollment. Participants will be monitored in the clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and acceptable, a second period of daily administration by the participant for 13 days will commence after a 5-49 day washout period. Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation of the second period. Additional safety assessments will be done by contacting participants between the 24-hour and 7-day visits and 7- and 14-day visits. The expected duration of study participation for each participant will be approximately 6-8 weeks. The primary endpoint is the proportion of participants who experience a related Grade 2 or higher adverse event. Secondary and exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability and the impact of Q-GRFT nasal spray on smell.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q-GRFT Nasal Spray | Active Comparator | 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. |
|
| Placebo Nasal Spray | Placebo Comparator | Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-Griffithsin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Grade 2 or Higher Adverse Events | Number of participants with Grade 2 or higher adverse events deemed related to study product | Approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours | Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after intranasal application of a single dose of study product. | Approximately 24 hours |
| Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Brief Smell Identification Test (BSIT) Score | 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. |
Inclusion Criteria:
Willing and able to provide written informed consent
In general good health as determined by the site clinician
Negative SARS-CoV-2 test at screening
Fully vaccinated for SARS-CoV-2 (does not include booster vaccination)
Agree to abstain from any other investigational drug studies for the duration of the study
Agree to abstain from nasally administered products, including over-the-counter products, for the duration of the study
Report use of an effective method of contraception at enrollment and intending to continue use of an effective method for the duration of study participation. Acceptable methods include:
Agree to participate in all study-related assessments and procedures
Exclusion Criteria:
Abnormal nasal or throat exam at enrollment
If female, pregnancy, or within 42 days of last pregnancy at screening
If female, breastfeeding
Diagnosed with SARS-CoV-2 in the past 42 days at screening
Diagnosed or suspected respiratory tract infection in the past 14 days at screening (including asymptomatic SARS-CoV-2)
Participation in an investigational drug study in past 30 days at screening
Any condition that, in the opinion of the Investigator would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Use of any intranasal product in the 14 days prior to enrollment
Surgical procedure involving the nose or throat 90 days prior to enrollment
Any of the following laboratory abnormalities at screening:
Grade 2 or higher seasonal allergies at the time of enrollment
Reported use of illicit drugs
Use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Hillier, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ingrid Macio | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Related Grade 2 or Higher Adverse Events | Number of participants with Grade 2 or higher adverse events deemed related to study product | All participants randomized to study product are included in this analysis. | Posted | Count of Participants | Participants | Approximately 8 weeks |
|
Approximately 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Hillier, PhD | University of Pittsburgh | 412-641-6435 | hillsl@mwri.magee.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2022 | Dec 16, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2022 | Dec 16, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000712032 | q-griffithsin |
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|
| Placebo | Drug | A matched vehicle solution manufactured and dispensed in same applicators as the active comparator. |
|
Q-GRFT concentration in plasma collected 24 hours after the final intranasal application of 13 consecutive once daily administrations of study product. |
| 24 hours after final dose of study product |
| Area Under the Plasma Concentration Versus Time Curve of Q-GRFT | 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. | Approximately 28 days |
| Acceptability of the Intranasal Spray | 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. | Approximately 14 days |
| Approximately 14 days |
| Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours | Q-GRFT concentration from nares swab eluent collected 24 hours after intranasal application of a single dose of study product. | Approximately 24 hours |
| Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | Approximately 14 days |
| Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from nares swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | Approximately 14 days |
| Q-GRFT Concentration From Rectal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from rectal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | Approximately 14 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Gender identity by participant report | Count of Participants | Participants |
|
| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| COVID-19 Diagnosis | Participant received one or more positive diagnoses for COVID-19 in the past | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
|
| Secondary | Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours | Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after intranasal application of a single dose of study product. | All participants on whom a nasopharyngeal swab was collected 24 hours after intranasal application of a single dose of study product. | Posted | Median | Inter-Quartile Range | ng/mL | Approximately 24 hours |
|
|
|
|
| Secondary | Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration in plasma collected 24 hours after the final intranasal application of 13 consecutive once daily administrations of study product. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Median | Inter-Quartile Range | ng/mL | 24 hours after final dose of study product |
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve of Q-GRFT | 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. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Median | Inter-Quartile Range | ng x day/mL | Approximately 28 days |
|
|
|
| Secondary | Acceptability of the Intranasal Spray | 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. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Count of Participants | Participants | No | Approximately 14 days |
|
|
|
|
| Other Pre-specified | Mean Change in Brief Smell Identification Test (BSIT) Score | 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. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Mean | Standard Deviation | score on a scale | Approximately 14 days |
|
|
|
|
| Other Pre-specified | Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours | Q-GRFT concentration from nares swab eluent collected 24 hours after intranasal application of a single dose of study product. | All participants on whom a nares swab was collected 24 hours after intranasal application of a single dose of study product. | Posted | Median | Inter-Quartile Range | ng/mL | Approximately 24 hours |
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|
|
|
| Other Pre-specified | Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from nasopharyngeal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Median | Inter-Quartile Range | ng/mL | Approximately 14 days |
|
|
|
|
| Other Pre-specified | Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from nares swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | The 3 participants in the Q-GRFT arm that withdrew from the study were excluded. | Posted | Median | Inter-Quartile Range | ng/mL | Approximately 14 days |
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|
|
|
| Other Pre-specified | Q-GRFT Concentration From Rectal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications | Q-GRFT concentration from rectal swab eluent collected 24 hours after the last dose of 13 consecutive daily intranasal applications of study product. | Twenty out of 50 participants consented to provide a rectal swab sample. | Posted | Median | Inter-Quartile Range | ng/mL | Approximately 14 days |
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|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 29 |
| 33 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 14 | 17 |
| Nasal Irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Increased Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Edematous Nasal Turbinates | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Blood on Nasopharyngeal Swab | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |