Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis

NCT05180500 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: STUDY211000093P30CA047904-32S5
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19; Pharmacokinetics; Safety

Keywords

Intranasal spray; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours

  Approximately 24 hours

• Q-GRFT Plasma Concentration Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications

  24 hours after final dose of study product

• Area Under the Plasma Concentration Versus Time Curve of Q-GRFT

  Approximately 28 days

• Acceptability of the Intranasal Spray

  Approximately 14 days

Other Outcomes (5)

• Mean Change in Brief Smell Identification Test (BSIT) Score

  Approximately 14 days

• Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours

  Approximately 24 hours

• Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications

  Approximately 14 days

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Q-GRFT Nasal Spray

Placebo DRUG

A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Sharon Hillier: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ingrid Macio

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

q-griffithsin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sharon Hillier, PhD
• Organization: University of Pittsburgh

hillsl@mwri.magee.edu

412-641-6435

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: March 15, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: April 23, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)