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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05180500

COVID-19 Pharmacokinetics Safety

COMPLETED PHASE1

A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients

NCT05659602

Coronavirus Disease 2019(COVID-19)

COMPLETED NA

Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)

NCT04365257

COVID-19

TERMINATED PHASE2

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

NCT05109611

SARS-CoV-2 Infection

TERMINATED PHASE3

Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

NCT05599919

SARS-CoV-2 Infection

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Pharmacy will perform randomization and maintain blinding.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

intranasal spray administered as a single dose

Q-Griffithsin

Group Type EXPERIMENTAL

Q-Griffithsin

Intervention Type DRUG

intranasal spray administered as a single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Q-Griffithsin

intranasal spray administered as a single dose

Intervention Type DRUG

Placebo

intranasal spray administered as a single dose

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age of 18 through 60 years at screening.
2. COVID-19 negative using Rapid antigen test at screening
3. Able and willing to provide written informed consent to take part in the study.
4. Able and willing to provide adequate information for locator purposes.
5. Availability to return for all study visits, barring unforeseen circumstances.
6. Agree not to participate in other research studies involving drugs and/or medical devices during the study period.
7. 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
8. Willingness and ability to safely defer vaccinations until after study participation is completed.
9. Must be in general good health in the opinion of the investigator.

Exclusion Criteria

1. 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.
2. Participants who report any of the following at Screening:

1. Ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing.
2. 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).
3. 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.
4. Participants who are current smokers.
5. Known Allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product.
6. 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.
7. History of alcohol/ substance abuse within 6 months of study enrollment.
8. History of any vaccination within the 2 weeks prior to enrollment.
9. Participating in another research study involving drugs or medical devices within the 4 weeks prior to enrollment
10. Having plans to relocate away from the study site area during the period of study participation
3. Has any of the following laboratory abnormalities at Screening:

1. White blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3
2. Hemoglobin \<12 g/dL for men and \<11 g/dL for women.
3. Calculated creatinine clearance \>1.1 x upper limit of normal (ULN)
4. Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) \> 1.1 × the site laboratory ULN
5. Total bilirubin \> 1.1 x ULN
6. ≥ +1 glucose or +2 protein on urinalysis (UA)
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes