Development and validation of a product acceptability questionnaire for intranasal Q-Griffithsin COVID-19 prophylaxis (SPRAY PAL).

ABSTRACT:

Objectives

Patient experiences are critical when determining the acceptability of novel interventional pharmaceuticals. Here, we report the development and validation of a product acceptability questionnaire (SPRAY PAL) assessing feasibility, acceptability and tolerability of an intranasal Q-Griffithsin (Q-GRFT) drug product designed for COVID-19 prophylaxis.

Design

SPRAY PAL validation was undertaken as part of an ongoing phase 1 clinical trial designed to test the safety, pharmacokinetics and tolerability of intranasally administered Q-GRFT for the prevention of SARS-CoV-2 infection.

Setting

The phase 1 clinical trial took place at a University Outpatient Clinical Trials Unit from November 2021 to September 2023.

Participants

The initial SPRAY PAL questionnai

SUBMITTER: Cash E 

PROVIDER: S-EPMC10503384 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature