Trial results for a study investigating hypertonic saline nasal irrigation and gargling for COVID-19 were posted on ClinicalTrials.gov on 2026-03-03. The trial, which was terminated, enrolled 16 participants and compared the intervention to standard care, with standard care showing a mean symptom resolution of 4 days compared to 5.5 days for the saline group.
Background
COVID-19, caused by the SARS-CoV-2 virus, primarily manifests as an upper respiratory tract infection but can affect multiple organ systems. Managing symptoms at home has been a key strategy throughout the pandemic. Simple, accessible interventions like nasal irrigation and gargling with hypertonic saline have been explored for their potential to reduce viral load and alleviate symptoms in various upper respiratory tract infections. This trial aimed to assess the utility of such an intervention in individuals with suspected or confirmed COVID-19 managed at home.
Trial design
The ELVIS COVID-19 trial was a pragmatic web-based Bayesian adaptive randomized controlled, parallel group study, designated as Phase NA. It was terminated after enrolling 16 participants. The study investigated conditions including Upper Respiratory Tract Infections, Virus, COVID, Virus Shedding, and Virus Diseases. Participants were randomized to receive either hypertonic saline nasal irrigation and gargling (HSNIG) or standard care. The trial's brief summary indicates it aimed to compare HSNIG to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home. No specific primary outcome measures were listed in the posted results.
Key results
The trial reported key measurements for symptom resolution and severity:
- Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'.
- For the Hypertonic Saline Nasal Irrigation and Gargling group, the mean time was 5.5 days (Standard Deviation 4.57).
- For the Standard Care group, the mean time was 4 days (Standard Deviation 3.61).
- Severity of All Symptoms (measured on a scale):
- In one measurement, the Hypertonic Saline Nasal Irrigation and Gargling group had a mean of 3.38 (Standard Deviation 0.74), while the Standard Care group had a mean of 2.33 (Standard Deviation 1.15).
- In another measurement, the Hypertonic Saline Nasal Irrigation and Gargling group had a mean of 2.71 (Standard Deviation 1.5), while the Standard Care group had a mean of 1.33 (Standard Deviation 1.53).
- A further measurement showed the Hypertonic Saline Nasal Irrigation and Gargling group with a mean of 2.33 (Standard Deviation 1.97), compared to the Standard Care group with a mean of 2 (Standard Deviation 1.41).
- Another measurement indicated a mean of 3.33 (Standard Deviation 2.08) for the Hypertonic Saline Nasal Irrigation and Gargling group, versus 1.5 (Standard Deviation 2.12) for the Standard Care group.
- Finally, the Hypertonic Saline Nasal Irrigation and Gargling group had a mean of 2.75 (Standard Deviation 1.71), while the Standard Care group had a mean of 1 (Standard Deviation null).
A t-test (2-sided) for a Mean Difference (Final Values) of 1.5 yielded a p-value of 0.624. The analysis notes that this test was done on a small sample size and should be interpreted with caution.
What this means
The ELVIS COVID-19 trial, though terminated with a small enrollment of 16 participants, provides initial data comparing hypertonic saline nasal irrigation and gargling to standard care for home-managed COVID-19. The results suggest that the intervention group had a longer mean time to symptom resolution (5.5 days vs. 4 days for standard care) and generally higher mean symptom severity scores across several measurements. The reported mean difference of 1.5 with a p-value of 0.624 indicates no statistically significant difference between the groups for the analyzed outcome, a finding that is explicitly cautioned due to the small sample size. These results do not support a benefit of hypertonic saline nasal irrigation and gargling over standard care in this limited dataset.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04382131, titled "Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)", were posted on 2026-03-03 on clinicaltrials.gov.