Complementary Application of the Ozonized Saline Solution in Moderate and Severe Patients with Pneumonia Covid-19: Efficacy and Tolerability

Background

When the COVID-19 pandemic took hold in early 2020, doctors were treating patients with severe lung infections caused by SARS-CoV-2 while still working out which supportive treatments genuinely helped alongside standard hospital care. Severe cases often involved a strong inflammatory response and abnormal blood-clotting markers, alongside prolonged shedding of the virus. A group of researchers in Spain investigated whether ozonised saline solution - a sterile saline solution infused with a small, controlled dose of medical ozone gas - could be given intravenously as a complementary treatment to standard hospital care, building on earlier laboratory and preclinical work suggesting ozone might help modulate inflammation and support the body's antioxidant defences.

Study design

The researchers ran a small, non-randomised pilot study - meaning there was no comparison (control) group receiving a placebo or different treatment, and patients were not randomly assigned to different groups. Twenty-five adult patients admitted to a hospital in Madrid, Spain, between 18 and 26 April 2020 with mild-to-severe COVID-19 pneumonia took part. The median age was 55 (range 30 to 95); just over half needed supplemental oxygen on admission, and around three-quarters had severe disease.

All patients received standard hospital care plus daily intravenous infusions of ozonised saline solution (200 mL) for up to 10 sessions. The ozone dose was tapered over the course of treatment: a higher concentration for the first five sessions (delivering 250 micrograms of ozone per day), then a lower concentration for the next five (150 micrograms per day). Each infusion was given over 15 to 30 minutes. The team tracked clinical symptoms (breathlessness, weakness, body temperature), blood biomarkers linked to inflammation and clotting (D-dimer, fibrinogen, lactate dehydrogenase, C-reactive protein and ferritin), how long patients continued to test positive for the virus (viral shedding), a standard seven-point scale used to track COVID-19 disease severity, and survival at 7 and 14 days.

Findings

No side effects were reported from the ozonised saline infusions. None of the 25 patients died during the study period. By day 14, 18 of the 25 patients (72%) had improved enough to be discharged from hospital. The inflammatory and clotting biomarkers monitored - D-dimer, fibrinogen, lactate dehydrogenase and C-reactive protein - fell significantly over the course of treatment. The median length of time patients continued to test positive for the virus was 8 days.

What the authors concluded

The authors concluded that intravenous ozonised saline solution, given alongside standard care, was well tolerated and was associated with improvement in symptoms, inflammatory markers and time to viral clearance in this small group of hospitalised COVID-19 patients. They suggested the approach warranted further investigation in other viral respiratory illnesses with a similar clinical profile, while being explicit that their findings were preliminary.

Limitations of this study

The authors themselves flagged the main limitation: this was a small, uncontrolled pilot study with no comparison group, so results were instead compared informally against outcomes reported in other published COVID-19 studies rather than a matched control arm within this study. With only 25 patients and no randomisation or blinding, it isn't possible to say from this study alone whether the ozonised saline caused the improvements seen, or whether other factors - including standard care itself or the natural course of the illness - played a role. The authors were explicit on this point, stating that without a sufficiently powered randomised controlled trial, they did not recommend applying ozonised saline solution to COVID-19 or other viral infections outside of further research settings.