Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 6:09 AM
Study NCT ID:
NCT05122260
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2021-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREVENT-COVID-19: A Q-Griffithsin Intranasal Spray
Sponsor:
Kenneth Palmer
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MCDC2006-010 | OTHER_GRANT | Department of Defense | View |