Interim analysis of an open‐label randomized controlled trial evaluating nasal irrigations in non‐hospitalized patients with coronavirus disease 2019

Kimura et al., International Forum of Allergy & Rhinology, doi:10.1002/alr.22703, Oct 2020

https://c19early.org/kimura2.html

Interim analysis of an open-label RCT of 45 non-hospitalized COVID-19 patients showing nasal irrigation with hypertonic saline significantly reduced days to symptom resolution for nasal congestion and headache. The study compared three arms: no intervention, twice-daily irrigation with hypertonic saline (HTS), and hypertonic saline with 1% surfactant (HTSS). Patients using HTS and HTSS experienced resolution of nasal congestion (7-9 days sooner) and headache (7-9 days sooner) than the control group. There was also a trend toward earlier overall symptom resolution (14 days for control vs. 10 days for both intervention groups) and improvement in cough and fatigue, though these did not reach statistical significance. Authors recommend hypertonic saline irrigation as a safe, inexpensive intervention for symptom reduction in COVID-19 patients.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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recovery time, 28.6% lower, relative time 0.71, p = 0.16, treatment 14, control 17.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Kimura et al., 20 Oct 2020, Randomized Controlled Trial, USA, peer-reviewed, 10 authors. Contact: justin.h.turner@vumc.org.

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Interim analysis of an open‐label randomized controlled trial evaluating nasal irrigations in non‐hospitalized patients with coronavirus disease 2019

MD Kyle S Kimura, MD Michael H Freeman, BE Bronson C Wessinger, BS Veerain Gupta, PhD Quanhu Sheng, PhD Li Ching Huang, Kate Von Wahlde, Suman R Das, MD Naweed I Chowdhury, MDPhD Justin H Turner

International Forum of Allergy & Rhinology, doi:10.1002/alr.22703

ysis of an open-label randomized controlled trial evaluating nasal irrigations in non-hospitalized patients with coronavirus disease Int Forum Allergy Rhinol -Response to the coronavirus disease 2019 (COVID-19) pandemic has primarily focused on pharmacologic and medical interventions, including antivirals, 1 convalescent sera, 2 and vaccinations, 3 with each potentially critical in the fight against COVID-19, particularly among high-risk and hospitalized populations. Non-hospitalized patients with mild to moderate disease comprise an estimated 81% of those affected with COVID-19, 4 and there are currently no widely available interventions with proven ability to hasten symptom resolution or reduce viral shedding. We started an open-label randomized controlled trial (RCT) to evaluate the effect of nasal irrigation with hypertonic saline (HTS) or saline with surfactant on upper respiratory symptoms and viral load. Viral shedding is highest in the nasal

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Late treatment
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