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NCT05122260

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

Completed Phase 1 Last updated 29 April 2022
What this trial tests

Phase 1 trial testing Q-Griffithsin in COVID-19 Prevention in 18 participants. Completed in 14 February 2022.

Timeline
11 November 2021
Primary endpoint
27 January 2022
14 February 2022

Quick facts

Lead sponsorKenneth Palmer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment18
Start date11 November 2021
Primary completion27 January 2022
Estimated completion14 February 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kenneth Palmer — full company profile →

Who can join

Adults 18 to 60, any sex, with COVID-19 Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Delivery of biologics: Topical administration.
    Kulchar RJ, Singh R, Ding S, Alexander E, et al · · 2023 · cited 31× · PMID 37690380 · DOI 10.1016/j.biomaterials.2023.122312
  2. Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL).
    Cash E, Deitz K, Potts KL, Nabeta HW, et al · · 2023 · cited 2× · PMID 37699630 · DOI 10.1136/bmjopen-2023-073735
  3. The Role of ACE2 in SARS-CoV-2 Infection, Pathogenesis, and Antiviral Interventions.
    McVoy MA, Kummarapurugu AB. · · 2025 · PMID 41347658 · DOI 10.1002/jmv.70721

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Data sources for this page

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