COVID-19 PreventionPhase 1NCT05437029
Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray
A Phase 1 study testing Q-Griffithsin 3.0 and Q-Griffithsin 6.0 in people with COVID-19 Prevention, run by Kenneth Palmer at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of multiple doses of a Q-GRFT nasal spray in healthy volunteers. This Q-GRFT nasal spray is "investigational and not approved by the FDA for general use" and is being developed to prevent the transmission of COVID-19 and other coronaviruses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Prevention
- What is being tested?
- Q-Griffithsin 3.0 and Q-Griffithsin 6.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID-19 negative using Rapid antigen test at screening.
- Able and willing to provide written informed consent to take part in the study.
- Able and willing to provide adequate information for locator purposes.
- Availability to return for all study visits, barring unforeseen circumstances.
- Agree not to participate in other research studies involving drugs and/or medical devices during the study period.
- Female participants must meet the following criteria:
Show all 14Show fewer
- Postmenopausal or using (or willing to use) an acceptable form of contraception (e.g., barrier method, IUD, hormonal contraception, sexual abstinence, surgical sterilization, or vasectomization of male partner).
- If the female participant has female partners only, the method of contraception will be noted as a barrier method for study documentation.
- Not be pregnant at the baseline or enrollment visit. Not be breastfeeding at screening or intend to breastfeed during study participation per participant report.
- Willingness and ability to defer vaccinations until after study participation is completed. This does not include COVID-19 vaccinations.
- Participants should have received all COVID-19 vaccines that they are eligible for. Those eligible for booster doses will not delay getting their dose for purposes of enrolling in the study. They will first obtain their booster dose and be re-evaluated for enrollment 2 weeks following their booster dose.
- Willingness to perform at-home study product self-administration according to written instructions that will be provided.
- Willingness to follow local guidelines for mask-wearing and face coverings.
- Must be in general good health in the opinion of the investigator.
Who cannot join
- Participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (COPD), and currently suffering from chronic rhinitis or acute/chronic sinusitis.
- Participants who report any of the following at Screening:
- Ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing.
- Participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes).
- Non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. Those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others.
- Participants who are current smokers.
Show all 20Show fewer
- Known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product.
- Use of systemic immunomodulatory medications (Thalidomide, Lenalidomide, Pomalidomide, Imiquimod, etc.), anticoagulants, and other drugs assessed by the site Investigator within the 4 weeks prior to study enrollment.
- History of alcohol/ substance abuse within 6 months of study enrollment.
- History of any vaccinations within the 2 weeks prior to enrollment.
- Participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment.
- Having plans to relocate away from the study site area during the period of study participation.
- Has any of the following laboratory abnormalities at Screening:
- White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3.
- Hemoglobin <12 g/dL for men and <11 g/dL for women.
- Calculated creatinine clearance >1.1 x upper limit of normal (ULN).
- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 1.1 × the site laboratory ULN.
- Total bilirubin > 1.1 x ULN.
- ≥ +1 glucose or +2 protein on urinalysis (UA).
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. Such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Louisville Clinical Trials Unit
Louisville, Kentucky, 40202
Angela Siegwald, RN, CCRN, MSCN, (502) 852-2043, angela.siegwald@louisville.edu
Amber Jackson, BS, (502) 569-7904, amber.jackson.1@louisville.edu
About this study
Official title: A Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of a Multiple Dosing Schedule of Q-Griffithsin Intranasal Spray for Broad-spectrum Coronavirus Prophylaxis: A Study of the PREVENT-CoV Program
The purpose of this study is to test the safety of multiple doses of a Q-GRFT nasal spray in healthy volunteers. This Q-GRFT nasal spray is "investigational and not approved by the FDA for general use" and is being developed to prevent the transmission of COVID-19 and other coronaviruses.
Read the detailed description
This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of Q GRFT intranasal spray DP.
Up to 24 healthy participants will be enrolled and assigned to either of 2 groups to receive treatment. In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days. The initial dose will be administered in the clinic by a study clinician. Participants will be taught how to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Group 1 participants will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 1 (1 hour, 6 hours, and 10 hours after the initial dose), day 2 (24±1 hours after initial dose), day 4 (pre-dose and 1-hour post-dose), day 7 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose, day 8 (24±1 hours) and day 9 (48±2 hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, day 1 and day 4 (1 hour post-dose), and on day 8, upon dose completion.
In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days. Administration of the third dose among Group 2 participants will be delayed to permit obtaining a 24-hour PK timepoint for one completed 6.0 mg BID treatment. The initial dose will be administered in the clinic by a study clinician. Participants will be taught to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Participants in this group will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 2 (1 hour, 6 hours, and 10 hours after the second dose), day 3 (24±1 hours after the second dose), day 5 (pre-dose after 3 completed doses of 6 mg and 1 hour post-dose), day 8 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose), day 9 (24±1 hours) and day 10 (48±2hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, on day 2 and day 5 (1 hour post-dose), and on day 9 after the final dose completion.
Safety assessment for both groups will be conducted after 3 days of dosing, upon completion of the final dose, and within 3-4 weeks of dose completion. An optional rectal fluids sampling procedure using a sponge will be performed 1 day after the final dose, to assess for any study product in the gastrointestinal tract. Blood draws for anti-drug antibodies/ immunogenicity assays will be performed at baseline, 24±1 hours after the final dose and 3-4 weeks after the final dose administration. Additional participants will be enrolled in case any subjects do not complete all safety or primary PK assessments, in order to assure that a minimum of 9 subjects is available for full analysis. All sampling procedures will be performed in the clinic.
This sample size is appropriate for a Phase 1b clinical study to gather additional multi-dosing safety data and preliminary PK data following completion of the single-dose treatment Phase 1a trial. The proposed studies will allow a careful selection of the ideal dose that will be administered to subjects in future Phase 2 studies.
- Conditions
- COVID-19 Prevention
- Being tested
- Q-Griffithsin 3.0, Q-Griffithsin 6.0
- Keywords
- COVID-19, Q-griffithsin, Nasal Spray, Prophylactic, Corona Virus, SARs CoV 2
- 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-Griffithsin 3.0Drug
Also called Q-Griffithsin Group 1
This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of low dose Q GRFT intranasal spray DP
Q-Griffithsin 6.0Drug
Also called Q-Griffithsin Group 2
This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of high dose Q GRFT intranasal spray DP
| Study group | Role | What they receive |
|---|---|---|
| Q-Griffithsin Group 1: 3.0 mg daily spray | Experimental | In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days. Receives: Drug: Q-Griffithsin 3.0 |
| Q-Griffithsin Group 2: two 3.0 mg sprays per day | Experimental | In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days. Receives: Drug: Q-Griffithsin 6.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic levels
Q-GRFT Study Product (SP) concentration will be assessed in nasopharyngeal fluids.
Measured: Nasopharyngeal fluids on days 1, 2, 4, 7, 8, 9 for group 1; Days 2, 3, 5, 8, 9 for group 2
Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.
Incidence of AEs Grade 3 or higher as defined by the Division of AIDS (DAIDS) Table or Grading the Severity of Adult and Pediatric Adverse Events, V2.1 (July 2017).
Measured: 3-4 weeks
Secondary outcomes (5)
Smell Assessment by Brief Smell Identification Test
Smell Assessment will be performed using the Sensonics International Brief Smell Identification Test (BSIT) to evaluate the impact of Q GRFT SP intranasal treatment on the sensation. This is a "scratch and sniff" type test with a set number of defined odors that participants should be able to identify. Modification of smell perception can be identified by changes in the results of the BSIT>
Measured: Visit 0, 6 or 7 (Day 9)
Acceptability
The product acceptability will be assessed to determine perception of use by participants. This is achieved through a assessing participants' responses to defined questions on a questionnaire that asks how the participants feel about their experiences with the investigational nasal spray product, and how likely they might be to use the product if it is approved for use. A majority of answers indicating a negative impression of the user experience will alert the study team to the possibility that the product will not be acceptable for use if approved and marketed as a nasal spray to prevent virus infection.
Measured: 3 - 4 weeks
Quality of life outcome
Quality of Life will be evaluated with the SF-12 battery of questions. The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Measured: Visit 0, 6 or 7 (Day 9)
Anti-drug antibody levels
Anti-drug antibodies (ADA) will be measured in collected plasma to assess if any anti-QGRFT antibodies are generated after multiple Q-GRFT SP treatment
Measured: Day 8 or 9
Pharmacokinetic levels
Q-GRFT Study Product (SP) concentration will be assessed in plasma.
Measured: 3 - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start15 Jun 2022
- Primary completion15 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PreventionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenneth Palmer
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Kenneth Palmer, University of Louisville
- Investigators
- Gerald W Dryden, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437029
- Sponsor's protocol ID
- 22.0224
- Other IDs
- MCDC2006-010
- Status last verified
- Jun 2022
- First submitted
- 13 May 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.
PubMed 8614203Chen H, Cisternas MG, Katz PP, Omachi TA, Trupin L, Yelin EH, Balmes JR, Blanc PD. Evaluating quality of life in patients with asthma and rhinitis: English adaptation of the rhinasthma questionnaire. Ann Allergy Asthma Immunol. 2011 Feb;106(2):110-118.e1. doi: 10.1016/j.anai.2010.10.027. Epub 2011 Jan 8.
PubMed 21277512Doty RL. Office procedures for quantitative assessment of olfactory function. Am J Rhinol. 2007 Jul-Aug;21(4):460-73. doi: 10.2500/ajr.2007.21.3043.
PubMed 17882917Cash E, Deitz K, Potts KL, Nabeta HW, Zahin M, Rai SN, Dryden GW, Palmer KE. Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL). BMJ Open. 2023 Sep 12;13(9):e073735. doi: 10.1136/bmjopen-2023-073735.
PubMed 37699630
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of a Multiple Dosing Schedule of Q-Griffithsin Intranasal Spray for Broad-spectrum Coronavirus Prophylaxis: A Study of the PREVENT-CoV Program
- ClinicalTrials.gov ID
- NCT05437029
- Acronym / sponsor ID
- 22.0224
- Conditions
- COVID-19 Prevention
- Keywords
- COVID-19, Q-griffithsin, Nasal Spray, Prophylactic, Corona Virus, SARs CoV 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kenneth PalmerUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety of multiple doses of a Q-GRFT nasal spray in healthy volunteers. This Q-GRFT nasal spray is "investigational and not approved by the FDA for general use" and is being developed to prevent the transmission of COVID-19 and other coronaviruses.
Detailed description
This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of Q GRFT intranasal spray DP.
Up to 24 healthy participants will be enrolled and assigned to either of 2 groups to receive treatment. In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days. The initial dose will be administered in the clinic by a study clinician. Participants will be taught how to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Group 1 participants will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 1 (1 hour, 6 hours, and 10 hours after the initial dose), day 2 (24±1 hours after initial dose), day 4 (pre-dose and 1-hour post-dose), day 7 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose, day 8 (24±1 hours) and day 9 (48±2 hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, day 1 and day 4 (1 hour post-dose), and on day 8, upon dose completion.
In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days. Administration of the third dose among Group 2 participants will be delayed to permit obtaining a 24-hour PK timepoint for one completed 6.0 mg BID treatment. The initial dose will be administered in the clinic by a study clinician. Participants will be taught to self-administer the study product at the clinic and receive written instructions for at-home self-administration. Subsequent doses will be self-administered either at the clinic or at home. Participants in this group will undergo PK sampling (nasal and nasopharyngeal fluids) at baseline (enrollment visit), on day 2 (1 hour, 6 hours, and 10 hours after the second dose), day 3 (24±1 hours after the second dose), day 5 (pre-dose after 3 completed doses of 6 mg and 1 hour post-dose), day 8 (pre-dose, 1 hour, 6 hours, and 10 hours after the final dose), day 9 (24±1 hours) and day 10 (48±2hours) following the final dose. Blood for evaluation of systemic exposure will be collected at baseline, on day 2 and day 5 (1 hour post-dose), and on day 9 after the final dose completion.
Safety assessment for both groups will be conducted after 3 days of dosing, upon completion of the final dose, and within 3-4 weeks of dose completion. An optional rectal fluids sampling procedure using a sponge will be performed 1 day after the final dose, to assess for any study product in the gastrointestinal tract. Blood draws for anti-drug antibodies/ immunogenicity assays will be performed at baseline, 24±1 hours after the final dose and 3-4 weeks after the final dose administration. Additional participants will be enrolled in case any subjects do not complete all safety or primary PK assessments, in order to assure that a minimum of 9 subjects is available for full analysis. All sampling procedures will be performed in the clinic.
This sample size is appropriate for a Phase 1b clinical study to gather additional multi-dosing safety data and preliminary PK data following completion of the single-dose treatment Phase 1a trial. The proposed studies will allow a careful selection of the ideal dose that will be administered to subjects in future Phase 2 studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q-Griffithsin Group 1: 3.0 mg daily spray | Experimental | Drug: Q-Griffithsin 3.0In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days. |
| Q-Griffithsin Group 2: two 3.0 mg sprays per day | Experimental | Drug: Q-Griffithsin 6.0In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- COVID-19 negative using Rapid antigen test at screening.
- Able and willing to provide written informed consent to take part in the study.
- Able and willing to provide adequate information for locator purposes.
- Availability to return for all study visits, barring unforeseen circumstances.
- Agree not to participate in other research studies involving drugs and/or medical devices during the study period.
Key exclusion criteria (20 listed)
- Participants with ongoing moderate to severe allergic rhinitis, asthma, or history of chronic obstructive pulmonary disease (COPD), and currently suffering from chronic rhinitis or acute/chronic sinusitis.
- Participants who report any of the following at Screening:
- Has any of the following laboratory abnormalities at Screening:
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study, or unable to comply with the study requirements. Such conditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease, severe nasal septum deviation, or other condition that may cause nasal obstruction like nasal polyps or nasal/ sinus surgery in the past.
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-Griffithsin 3.0Also: Q-Griffithsin Group 1This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of low dose Q GRFT intranasal spray DP | Drug | Q-Griffithsin Group 1: 3.0 mg daily spray |
| Q-Griffithsin 6.0Also: Q-Griffithsin Group 2This is an open-label dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of a multiple dosing schedule of high dose Q GRFT intranasal spray DP | Drug | Q-Griffithsin Group 2: two 3.0 mg sprays per day |
Primary outcome
Pharmacokinetic levels
Time frame: Nasopharyngeal fluids on days 1, 2, 4, 7, 8, 9 for group 1; Days 2, 3, 5, 8, 9 for group 2
Q-GRFT Study Product (SP) concentration will be assessed in nasopharyngeal fluids.
Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.
Time frame: 3-4 weeks
Incidence of AEs Grade 3 or higher as defined by the Division of AIDS (DAIDS) Table or Grading the Severity of Adult and Pediatric Adverse Events, V2.1 (July 2017).
5 secondary outcomes
Smell Assessment by Brief Smell Identification Test
Time frame: Visit 0, 6 or 7 (Day 9)
Acceptability
Time frame: 3 - 4 weeks
Quality of life outcome
Time frame: Visit 0, 6 or 7 (Day 9)
Anti-drug antibody levels
Time frame: Day 8 or 9
Pharmacokinetic levels
Time frame: 3 - 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 8614203Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.
- Background: PubMed 21277512Chen H, Cisternas MG, Katz PP, Omachi TA, Trupin L, Yelin EH, Balmes JR, Blanc PD. Evaluating quality of life in patients with asthma and rhinitis: English adaptation of the rhinasthma questionnaire. Ann Allergy Asthma Immunol. 2011 Feb;106(2):110-118.e1. doi: 10.1016/j.anai.2010.10.027. Epub 2011 Jan 8.
- Background: PubMed 17882917Doty RL. Office procedures for quantitative assessment of olfactory function. Am J Rhinol. 2007 Jul-Aug;21(4):460-73. doi: 10.2500/ajr.2007.21.3043.
- Derived from this study: PubMed 37699630Cash E, Deitz K, Potts KL, Nabeta HW, Zahin M, Rai SN, Dryden GW, Palmer KE. Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL). BMJ Open. 2023 Sep 12;13(9):e073735. doi: 10.1136/bmjopen-2023-073735.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Prevention
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 1
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
COVID -19, COVID-19 (Prevention)
Not yet recruitingPhase 1
Safety, Tolerability, and Immunogenicity of BMI2012 Against COVID-19 Variant in Healthy Adults Aged 19 and 55 Years
Prevention of COVID-19 Variant (Omicron JN.1)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections
RecruitingPhase 1/2
A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
COVID-19, SARS-CoV-2 Infection
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.
Gerald W Dryden, MD, PhD principal investigator
University of Louisville
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 3.0 and Q-Griffithsin 6.0 in people with COVID-19 Prevention, run by Kenneth Palmer 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 14 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Siegwald, RN (502-852-2043, angela.siegwald@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic levels (time frame: Nasopharyngeal fluids on days 1, 2, 4, 7, 8, 9 for group 1; Days 2, 3, 5, 8, 9 for group 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437029, which also lists 4 linked publications.
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 5 Jul 2022.