COVID-19Phase 1NCT05180500
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
A Phase 1 study testing Q-Griffithsin in people with COVID-19 and Pharmacokinetics, run by Sharon Hillier at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pharmacokinetics, Safety
- What is being tested?
- Q-Griffithsin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 7 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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:
- Males: Male condoms, sterilization of participant or partner, partner use of hormonal contraception or intrauterine device, identifies as a man who has sex with men exclusively, and/or sexually abstinent for the past 60 days and agrees to remain abstinent for the study duration
- Females: Hormonal methods at the time of enrollment, intrauterine device inserted prior to enrollment, sterilization of participant or partner, consistent condom use of male partner for at least 28 days (reports using condoms 10 times in the last 10 acts of intercourse), identifies as a woman who has sex with women exclusively, and/or sexually abstinent for the past 60 days and agrees to remain abstinent for the study duration.
- Agree to participate in all study-related assessments and procedures
Who cannot join
- 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
Show all 18Show fewer
- 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:
- Hgb < 12g/dL (men) and < 11g/dL (women)
- Serum creatinine > 1.1 x upper limit of normal
- alanine transaminase, aspartate aminotransferase, and total bilirubin > 1.1 x upper limit of normal
- Grade 2 or higher seasonal allergies at the time of enrollment
- Reported use of illicit drugs
- Non-therapeutic injection drug use in the 12 months prior to screening
- Any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening
- Use of systemic prescription immunomodulatory medications within the 4 weeks prior to the enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Clinical Trial of a Q GRFT Nasal Spray
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.
Read the detailed description
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.
- Conditions
- COVID-19, Pharmacokinetics, Safety
- Being tested
- Q-Griffithsin, Placebo
- Keywords
- Intranasal spray, Prophylaxis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-GriffithsinDrug
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.
PlaceboDrug
A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Q-Griffithsin |
| Placebo Nasal Spray | Placebo comparator | Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 8 weeks
Secondary outcomes (4)
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.
Measured: Approximately 24 hours
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.
Measured: 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.
Measured: 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.
Measured: Approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Mar 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Hillier
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Sharon Hillier, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180500
- Sponsor's protocol ID
- STUDY21100009
- Other IDs
- 3P30CA047904-32S5
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of a Q GRFT Nasal Spray
- ClinicalTrials.gov ID
- NCT05180500
- Acronym / sponsor ID
- STUDY21100009
- Conditions
- COVID-19, Pharmacokinetics, Safety
- Keywords
- Intranasal spray, Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sharon HillierUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q-GRFT Nasal Spray | Active comparator | Drug: Q-GriffithsinQ-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 | Drug: PlaceboPlacebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-GriffithsinQ-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. | Drug | Q-GRFT Nasal Spray |
| PlaceboA matched vehicle solution manufactured and dispensed in same applicators as the active comparator. | Drug | Placebo Nasal Spray |
Primary outcome
Number of Participants With Related Grade 2 or Higher Adverse Events
Time frame: Approximately 8 weeks
Number of participants with Grade 2 or higher adverse events deemed related to study product
4 secondary outcomes
Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours
Time frame: Approximately 24 hours
Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
Time frame: 24 hours after final dose of study product
Area Under the Plasma Concentration Versus Time Curve of Q-GRFT
Time frame: Approximately 28 days
Acceptability of the Intranasal Spray
Time frame: Approximately 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q-Griffithsin in people with COVID-19 and Pharmacokinetics, run by Sharon Hillier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Related Grade 2 or Higher Adverse Events (time frame: Approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.