CompletedPhase 1

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

United States18 participantsStarted 2021-11-11

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Willingness and ability to safely defer vaccinations until after study participation is completed.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 3 Weeks

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

Timeframe: 3 Weeks

Pharmacokinetics of the product

Timeframe: 3 Weeks

Trial details

NCT IDNCT05122260

SponsorKenneth Palmer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-27

View on ClinicalTrials.gov More COVID-19 Prevention trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Willingness and ability to safely defer vaccinations until after study participation is completed.

Exclusion criteria

✕. 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.