PREVENT-COVID-19: A Q-Griffithsin Intranasal Spray
Condition: COVID-19 Prevention
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Q-Griffithsin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): intranasal spray administered as a single dose; intranasal spray administered as a single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Q-Griffithsin; Nasal Spray; Prophylactic; Coronavirus; SARS-CoV-2