This study is a two-arm, randomized, 2-phase study. Phase I will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing SARS-CoV-2 load in COVID 19+ adult individuals. Phase II is designed as an open label trial, and all subjects will receive the active mouthwash.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
[PCR Saliva] Percent Change From Baseline Ct Viral Targets
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2. \[Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)\].
Time frame: 60 minutes after intervention
[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
The secondary endpoints are the percentage reduction of SARS-Co-V-2 load in saliva at 5 and 30 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicated a decrease from baseline SARS-Co-V-2.
Time frame: 5 and 30 minutes post-intervention
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