Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Condition: COVID-19; Pharmacokinetics; Safety
MeSH terms: COVID-19
Intervention: Q-Griffithsin; Placebo
Intervention description: 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.; A matched vehicle solution manufactured and dispensed in same applicators as the active comparator.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intranasal spray; Prophylaxis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               1. 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

               2. 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

        Exclusion Criteria:

          -  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:

               1. Hgb < 12g/dL (men) and < 11g/dL (women)

               2. Serum creatinine > 1.1 x upper limit of normal

               3. 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

               1. Non-therapeutic injection drug use in the 12 months prior to screening

               2. Any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12
                  months prior to screening

          -  Use of systemic prescription immunomodulatory medications within the 4 weeks prior to
             the enrollment