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Seawater nasal wash to reduce symptom duration and viral load in COVID-19 and upper respiratory tract infections: a randomized controlled multicenter trial

de Gabory et al., European Archives of Oto-Rhino-Laryngology, doi:10.1007/s00405-024-08518-y, SeaCare, NCT04916639

Feb 2024

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RCT 355 adults with COVID-19 or other upper respiratory tract infections (URTIs). For COVID-19 patients there was lower progression and faster symptom resolution with alkaline seawater nasal wash (pH ~8) 4 times daily for 21 days. There was significantly lower transmission for patients with the delta variant and for patients with high viral load. The seawater nasal wash was safe and well-tolerated.

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risk of progression, 74.9% lower, RR 0.25, p < 0.001, treatment 7 of 82 (8.5%), control 31 of 91 (34.1%), NNT 3.9, day 21.

risk of progression, 67.6% lower, RR 0.32, p = 0.003, treatment 7 of 82 (8.5%), control 24 of 91 (26.4%), NNT 5.6, day 14.

risk of progression, 35.3% lower, RR 0.65, p = 0.47, treatment 7 of 82 (8.5%), control 12 of 91 (13.2%), NNT 22, day 7.

recovery time, 24.2% lower, relative time 0.76, p = 0.02, treatment mean 5.0 (±4.1) n=82, control mean 6.6 (±4.8) n=91, time to resume daily activities.

recovery time, 17.0% lower, relative time 0.83, p < 0.001, treatment 82, control 91, all symptoms combined.

recovery time, 25.5% lower, relative time 0.74, p = 0.03, treatment mean 3.5 (±2.8) n=82, control mean 4.7 (±4.2) n=91, dyspnea.

recovery time, 29.5% lower, relative time 0.71, p < 0.001, treatment mean 6.7 (±5.2) n=82, control mean 9.5 (±5.7) n=91, loss of smell.

recovery time, 25.6% lower, relative time 0.74, p = 0.005, treatment mean 6.7 (±5.6) n=82, control mean 9.0 (±5.1) n=91, loss of taste.

recovery time, 13.8% lower, relative time 0.86, p = 0.22, treatment mean 5.6 (±5.0) n=82, control mean 6.5 (±4.6) n=91, post-nasal drip.

recovery time, 10.7% lower, relative time 0.89, p = 0.36, treatment mean 5.0 (±4.7) n=82, control mean 5.6 (±3.9) n=91, facial pain.

recovery time, 1.8% higher, relative time 1.02, p = 0.89, treatment mean 5.6 (±5.0) n=82, control mean 5.5 (±4.6) n=91, sore throat.

recovery time, 25.5% lower, relative time 0.75, p = 0.04, treatment mean 3.8 (±3.5) n=82, control mean 5.1 (±4.6) n=91, chest congestion.

recovery time, 3.3% lower, relative time 0.97, p = 0.78, treatment mean 5.8 (±5.0) n=82, control mean 6.0 (±4.5) n=91, headache.

recovery time, 14.0% lower, relative time 0.86, p = 0.20, treatment mean 4.9 (±3.8) n=82, control mean 5.7 (±4.4) n=91, loss of appetite.

risk of no viral clearance, 36.6% lower, RR 0.63, p = 0.54, treatment 4 of 82 (4.9%), control 7 of 91 (7.7%), NNT 36, day 21.

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

de Gabory et al., 20 Feb 2024, Randomized Controlled Trial, France, peer-reviewed, 4 authors, study period July 2021 - March 2022, trial NCT04916639 (history) (SeaCare). Contact: ludovic.de-gabory@chu-bordeaux.fr.

This Paper Alkalinization All

Seawater nasal wash to reduce symptom duration and viral load in COVID-19 and upper respiratory tract infections: a randomized controlled multicenter trial

Ludovic De Gabory, Sophie Vallet, Gaëlle Naelten, Chantal Raherison-Semjen

European Archives of Oto-Rhino-Laryngology, doi:10.1007/s00405-024-08518-y

Purpose The objective was to assess the efficacy of seawater nasal wash on symptom duration, intranasal viral load, household transmission in COVID-19 and URTIs. Methods This prospective, randomized, controlled, multicentric, parallel study included 355 mild/moderate COVID-19 and URTI adults with rhinologic symptoms ≤ 48h. Active group performed 4-daily nasal washes with undiluted isotonic seawater versus control group (without nasal wash). Symptoms were self-assessed daily using the WURSS-21 questionnaire for 3 weeks. Viral load was measured by RT-PCR on nasopharyngeal swabs collected on Day 0, Day 5, Day 14 and Day 21. Digital droplet PCR was additionally performed for SARS-CoV-2. Results Overall COVID-19 subjects recovered earlier the ability to accomplish daily activities in the active group (-1.6 day, p = 0.0487) with earlier improvement of taste (-2 days, p = 0.0404). COVID-19 subjects with severe nasal symptoms at D0 showed the earliest resolution of anosmia (-5.2 days, p = 0.0281), post-nasal drip (-4.1 days, p = 0.0102), face pain/ heaviness (-4.5 days, p = 0.0078), headache (-3.1 days, p = 0.0195), sore throat (-3.3 days, p = 0.0319), dyspnea (-3.1 days, p = 0.0195), chest congestion (-2.8 days, p = 0.0386) and loss of appetite (-4.5 days, p = 0.0186) with nasal wash. In URTIs subjects, an earlier resolution of rhinorrhea (-3.5 days, p = 0.0370), post-nasal drip (-3.7 days, p = 0.0378), and overall sickness (-4.3 days, p = 0.0248) was reported with nasal wash. Evolution towards more severe COVID-19 was lower in active vs control, with earlier viral load reduction in youngest subjects (≥ 1.5log10 copies/10000 cells at Day 5: 88.9% vs 62.5%, p = 0.0456). In the active group, a lower percentage of SARS-CoV-2 positive household contacts (0-10.7%) was reported vs controls (3.2-16.1%) among subjects with Delta variant (p = 0.0413). Conclusion This trial showed the efficacy and safety of seawater nasal wash in COVID-19 and URTIs. Trial registration Trial registry ClinicalTrials.gov

Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1007/ s00405-024-08518-y. Author contributions Study protocol preparation and methodology: LG, SV, C R-S and GN. Data interpretation: LG, SV, C R-S and GN. Literature review: LG and GN. Manuscript preparation: LG and GN. Manuscript review: LG, SV, C R-S and GN. All the authors approved the present version for publication. Conflict of interest LG and SV and CR-S were scientific advisors for the study and therefore received fees from Laboratoire de la Mer. Employment GN is employee of Laboratoire de la Mer. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Publisher's Note..

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