Dataset Information

The Effect of Povidone-Iodine Nasal Spray on Nasopharyngeal SARS-CoV-2 Viral Load: A Randomized Control Trial.

ABSTRACT:

Objectives/hypothesis

To determine the effect of povidone-iodine (PVP-I) nasal sprays on nasopharyngeal (NP) viral load as assessed by cycle threshold (Ct) on quantitative polymerase chain reaction (qPCR) of SARS-CoV-2 in outpatients.

Study design

Three arm, triple blinded, randomized, placebo-controlled clinical trial.

Methods

Participants were randomized within 5 days of testing positive for COVID-19 to receive nasal sprays containing placebo (0.9% saline), 0.5% PVP-I, or 2.0% PVP-I. NP swabs for qPCR analysis were taken at baseline, 1-hour post-PVP-I spray (two sprays/nostril), and 3 days post-PVP-I spray (20 sprays/nostril). Symptom and adverse event questionnaires were completed at baseline, day 3, and day 5. University of Pennsylvania Smell Identification Tests (UPSIT) were completed at baseline and day 30.

Results

Mean Ct values increased over time in all groups, indicating declining viral loads, with no statistically significant difference noted in the rate of change between placebo and PVP-I groups. The 2.0% PVP-I group showed statistically significant improvement in all symptom categories; however, it also reported a high rate of nasal burning. Olfaction via UPSIT showed improvement by at least one category in all groups. There were no hospitalizations or mortalities within 30 days of study enrollment.

Conclusions

Saline and low concentration PVP-I nasal sprays are well tolerated. Similar reductions in SARS-CoV-2 NP viral load were seen over time in all groups. All treatment groups showed improvement in olfaction over 30 days. These data suggest that dilute versions of PVP-I nasal spray are safe for topical use in the nasal cavity, but that PVP-I does not demonstrate virucidal activity in COVID-19 positive outpatients.

Level of evidence

II Laryngoscope, 2021.

SUBMITTER: Zarabanda D

PROVIDER: S-EPMC8662040 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAlthough great progress has been made over the past 2 years in the scientific understanding of the biology, epidemiology, and pathogenesis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), case morbidity and fatality rates remain a great concern and continue to challenge the healthcare resources worldwide as novel variants emerge. There is therefore an urgent need for affordable and readily available strategies to reduce viral transmission. Previous studies in non-COVID-19 patients have demonstrated that administration of low-salt (isotonic but 0.0375% Na) and isotonic saline (0.9% Na) solutions has been associated with an immediate, significant reduction in the microbial antigens and a related decline of microbial burden. The aim of the present study was to determine the effect of nasal washes with normal saline 0.9% on nasopharyngeal viral load and outcome in hospitalized patients with COVID-19 pneumonia.MethodsWe performed a prospective, randomized, pilot, controlled trial in 50 patients with confirmed COVID-19 disease. Patients were randomized into two groups, the normal saline group (received normal saline 0.9% solution for nasopharyngeal wash) and the control group (no treatment). In the normal saline group, nasopharyngeal wash was performed every 4 hours for a 16-hour period. Twenty-four hours after the baseline nasopharyngeal swab (and 8 hours after the last wash in the normal saline group), a second nasopharyngeal swab was collected for the semiquantitative estimation of the SARS-CoV-2 viral load as determined by cycle threshold (Ct) values.ResultsIn the normal saline group, mean N gene Ct values increased significantly 24 hours after the baseline measurement [ΔCtday2-day1 = 1.87 ± 3.11 cycles, p = 0.007 (95% CI: 0.55 to 3.18)], indicating a decline in SARS-CoV-2 nasopharyngeal viral load by 8.9%. A significant decrease in mean N gene Ct values was observed in the control group, indicating an increase in viral load [ΔCtday2-day1 = -2.12 ± 2.66, p < 0.001 (95% CI: -3.20 to -1.05)] by 9.7%. The difference between the two groups 24 hours after admission and nasopharyngeal wash was 3.09 cycles (p = 0.005, 95% CI: 0.97 to 5.20).ConclusionNasal washes with normal saline effectively decreased the viral load during hospitalization and at follow-up.