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

NCT05122260 | Completed Phase 1 FDA Drug

• 2 other identifiers: 21.0704MCDC2006-010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19 Prevention

Keywords

COVID-19; Q-Griffithsin; Nasal Spray; Prophylactic; Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• 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.

  3 Weeks

• 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.

  3 Weeks

• Pharmacokinetics of the product

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

  3 Weeks

Secondary Outcomes (2)

• 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].

  3 Weeks

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

  3 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Q-Griffithsin

EXPERIMENTAL

Drug: Q-Griffithsin

Interventions

Q-Griffithsin DRUG

intranasal spray administered as a single dose

Q-Griffithsin

Placebo OTHER

intranasal spray administered as a single dose

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Kenneth Palmer: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (4)

• 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.

  PMID: 8614203 BACKGROUND

• 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.

  PMID: 21277512 BACKGROUND

• 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.

  PMID: 17882917 BACKGROUND

• 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.

  PMID: 37699630 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

q-griffithsin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacy will perform randomization and maintain blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 16, 2021
• Study Start: November 11, 2021
• Primary Completion: January 27, 2022
• Study Completion: February 14, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)