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

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.

Timeline

Start

2021-11-11

Primary completion

2022-01-27

Completion

2022-02-14

Publications

• Background Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.
• Background Chen H, Cisternas MG, Katz PP, Omachi TA, Trupin L, Yelin EH, Balmes JR, Blanc PD. Evaluating quality of life in patients with asthma and rhinitis: English adaptation of the rhinasthma questionnaire. Ann Allergy Asthma Immunol. 2011 Feb;106(2):110-118.e1. doi: 10.1016/j.anai.2010.10.027. Epub 2011 Jan 8.
• Background Doty RL. Office procedures for quantitative assessment of olfactory function. Am J Rhinol. 2007 Jul-Aug;21(4):460-73. doi: 10.2500/ajr.2007.21.3043.
• Cash E, Deitz K, Potts KL, Nabeta HW, Zahin M, Rai SN, Dryden GW, Palmer KE. Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL). BMJ Open. 2023 Sep 12;13(9):e073735. doi: 10.1136/bmjopen-2023-073735.

Drugs

Indications

No indication recorded.