Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Condition: COVID-19; Pharmacokinetics; Safety
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a phase 1 study for intranasal application of Q-Griffithsin (Q-GRFT) spray as a
      prophylactic for severe acute respiratory syndrome-CoV-2. This randomized,
      placebo-controlled, single site will assess the local and systemic safety of intranasal
      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. Accrual of approximately 45
      evaluable participants is expected to take 6 months. The expected duration of study
      participation for each participant will be approximately 6-8 weeks. 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 after a 5-49 day washout period.
      Safety assessments will be performed at day 7, day 14, and day 28 visits after the initiation
      of the second period. Additional safety assessments will be done by contacting participants
      between the 24-hour and 7-day visits and 7- and 14-day visits. 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.
    

Intervention name(s): Q-Griffithsin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Intranasal spray; Prophylaxis