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COVID-19 PreventionPhase 1NCT05122260

PREVENT-COVID-19: A Q-Griffithsin Intranasal Spray

A Phase 1 study testing Q-Griffithsin in people with COVID-19 Prevention, run by Kenneth Palmer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the first-in-human clinical study to see if a single dose of an investigational nasal spray made from a modified plant protein called Q-Griffithsin is safe, tolerated and acceptable for use by healthy adults 18 to 60 years of age. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Prevention
What is being tested?
Q-Griffithsin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
11 Nov 2021to 14 Feb 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age of 18 through 60 years at screening.
  • 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.
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  • Female participants must meet the following criteria:
  • 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 in the 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 safely defer vaccinations until after study participation is completed.
  • 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. Concomitant prescription medications may include systemic steroids, intranasal medicines, among others.
  • Participants who are current smokers.
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  • 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 the Enrollment.
  • History of alcohol/ substance abuse within 6 months of study enrollment.
  • History of any vaccination 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

  • University of Louisville

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: A Phase 1a Safety, Acceptability and Pharmacokinetics Study of Q-Griffithsin Intranasal Spray for Broad-spectrum Coronavirus Pre-exposure Prophylaxis: A Study of the PREVENT-COVID-19Program

This is the first-in-human clinical study to see if a single dose of an investigational nasal spray made from a modified plant protein called Q-Griffithsin is safe, tolerated and acceptable for use by healthy adults 18 to 60 years of age.

Read the detailed description

Q-Griffithsin (Q-GRFT) nasal spray is an investigational product that has broad spectrum antiviral activity. Q-GRFT is derived from Griffithsin (GRFT) a naturally occurring protein originally isolated from the red alga Griffithsia found in the South Pacific Ocean. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT. Q-GRFT is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, and hepatitis C Q-GRFT suppresses replication of many different coronaviruses, including coronaviruses that cause the common cold, as well as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus type-1 (SARS-CoV) as well as Severe Acute Respiratory Syndrome Coronavirus type-2 (SARS-CoV-2).

The investigational product is a nasal spray containing Q-GRFT, and other excipients designed to optimize delivery of Q-GRFT to the nasal and naso-pharyngeal mucosa, where SARS-CoV-2 often first initiates infection.

Up to 18 healthy individuals between the ages of 18 and 60 years will be enrolled at the University of Louisville. Participants will be assigned 2:1 In a randomized and blinded fashion to receive either the Q-GRFT nasal spray or a placebo nasal spray. Participants in this study will have screening procedures including lab tests and health questions. If they are eligible for the study, they will have blood drawn for additional lab tests, have an examination of their nasal cavity by a doctor using a scope, and have nasal and throat mucus samples collected. There will be one dose of a nasal spray after the participant is randomized to their respective group. Samples will be collected at 1, 6, and 24 hours as well as 3 days after the nasal spray dose. The participant will answer questions about their quality of life, medical history and current medical status, and their experience with the study treatment. Their COVID-19 antibodies will also be checked, and they will be informed of the results. This is a phase 1 trial. The first human tests of investigational drugs or therapies occur in Phase 1 trials. Phase 1 trials are designed to determine the best dose of the study drug and to check for any potential side effects.

Being tested
Q-Griffithsin, Placebo
Keywords
COVID-19, Q-Griffithsin, Nasal Spray, Prophylactic, Coronavirus, SARS-CoV-2
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q-GriffithsinDrug

    intranasal spray administered as a single dose

  • PlaceboOther

    intranasal spray administered as a single dose

Study groups in NCT05122260
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
Q-GriffithsinExperimentalNot described
Receives: Drug: Q-Griffithsin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety of a single exposure of Q-GRFT study product (SP) will be evaluated when administered via a nasal spray system.

    Incidence of AEs Grade 3 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events V2.1 (July 2017) will be used to determine whether the product is safe. Any emergent AEs will be discussed with the Safety Committee.

    All serious adverse events will be reported by the site investigator(s) to the Medical Monitor and IND Sponsor/Protocol Chair within 24 hours of the site becoming aware of the event.

    Measured: 3 Weeks

  2. The product acceptability will be assessed to determine its use by the participants

    The acceptability questionnaire will be filled out by the participants and provide participants' opinions on the spray characteristics, administration process, the applicator/spray design, and the use regimen, as well as the degree to which participants believe these characteristics and side-effects could pose barriers in future sustained use. The proportion of participants who report product characteristics to be considered a barrier in use, operationalized as having a rating of lower than 3 on a 5-point Likert scale, in disliking or likelihood of future barrier in use will be calculated and examined.

    Measured: 3 Weeks

  3. Pharmacokinetics of the product

    Q-GRFT Study Product (SP) concentration will be assessed in plasma, nasal, nasopharyngeal, and oropharyngeal fluids.

    Measured: 3 Weeks

Secondary outcomes (2)

  1. Smell assessment will be performed to evaluate the impact of Q-GRFT SP intranasal treatment on the sensation using the University of Pennsylvania Brief Smell Identification Test (BSIT), a validated assessment of olfactory function [1].

    The BSIT assesses an individual's ability to detect odors at a suprathreshold level. The test consists of 12 items provided in a 12-page booklet. On each page, there is a "scratch and sniff" strip embedded with a microencapsulated odorant along with 4 choice options. The scents are released by scratching the surface with a pencil, after which the participant smells the strip and chooses the odor from the four choices listed [2]. Scores range from 0-12. The BSIT has demonstrated good reliability (r=.71) and takes less than 5 minutes to complete.

    1. Doty, R.L., A. Marcus, and W. William Lee, Development of the 12-item cross-cultural smell identification test (CC-SIT). The Laryngoscope, 1996. 106(3): p. 353-356.
    2. Doty, R.L., Office procedures for quantitative assessment of olfactory function. Am J Rhinol, 2007. 21(4): p. 460-73.

    Measured: 3 Weeks

  2. Subject quality of Life (12-Item Short Form Survey (SF-12))

    will be evaluated with the SF-12 battery of questions. Scores range from 0-100, with higher scores indicating better physical and mental health functioning.

    Measured: 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start11 Nov 2021
  3. Primary completion27 Jan 2022
  4. Study completion14 Feb 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05122260
Sponsor's protocol ID
21.0704
Other IDs
MCDC2006-010
Status last verified
Apr 2022
First submitted
1 Nov 2021
Last updated
29 Apr 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 8614203

  • Chen 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 21277512

  • Doty 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 17882917

  • Cash 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Q-Griffithsin 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 12 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: finished, as of the sponsor's last update on 29 Apr 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The safety of a single exposure of Q-GRFT study product (SP) will be evaluated when administered via a nasal spray system. (time frame: 3 Weeks). The study lists 3 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 NCT05122260, 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 29 Apr 2022.

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