A Phase 1a/1b Clinical Trial Design to Assess Safety, Acceptability, Pharmacokinetics and Tolerability of Intranasal Q-Griffithsin for COVID-19 Prophylaxis
University of Louisville IRB# 21.0704 (Phase 1a) and IRB# 22.0224 (Phase 1b)
This PREVENT-CoV program is funded by the Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) through ATI under OTA MCDC2006-010. The funders did not have direct role in the collection, analysis, interpretation of data and writing of the manuscript. However, they reviewed all study related documents, and granted approval for publication of the manuscript. ClinicalTrials.gov number NCT05122260 (Phase 1a), NCT05437029 (Phase 1b)
Background: The COVID-19 pandemic remains an ongoing threat to global public health. Q-Griffithsin (Q-GRFT) is a lectin that has demonstrated potent broad-spectrum inhibitory activity in preclinical studies in models of Nipah virus and the beta coronaviruses SARS-CoV, MERS-CoV, and SARS-CoV-2.
Methods: Here, we propose a clinical trial design to test the safety, pharmacokinetics (PK), and tolerability of intranasally administered Q-GRFT for the prevention of SARS-CoV-2 infection as a prophylaxis strategy. The initial Phase 1a study will assess the safety and PK of a single dose of intranasally administered Q-GRFT. If found safe, the safety, PK, and tolerability of multiple doses of intranasal Q-GRFT will be assessed in a Phase 1b study. Group 1 participants will receive 3 mg of intranasal Q-GRFT (200 μL/nostril) once daily for 7 days. If this dose is tolerated, participants will be enrolled in Group 2 to receive 3 mg twice daily for 7 days. Secondary endpoints of the study will be user perceptions, acceptability, and the impact of product use on participants’ olfactory sensation and quality of life.
Discussion: Results from this study will support further development of Q-GRFT as a prophylactic against respiratory viral infections in future clinical trials.
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Nabeta, Henry W.; Zahin, Maryam; Fuqua, Joshua L.; Cash, Elizabeth D.; Leth, Ingrid; Strauss, Michael; Novak, Jeanne; Wang, Lin; Siegwald, Angela; Sheppard, Rachel A.; Rai, Shesh N.; Rohan, Lisa C.; Hillier, Sharon; Dryden, Gerald W.; Potts, Kevin L.; and Palmer, Kenneth E.
"A Phase 1a/1b Clinical Trial Design to Assess Safety, Acceptability, Pharmacokinetics and Tolerability of Intranasal Q-Griffithsin for COVID-19 Prophylaxis,"
The University of Louisville Journal of Respiratory Infections: Vol. 6
, Article 22.
Available at: https://ir.library.louisville.edu/jri/vol6/iss1/22