NCT06294756: STWandRVD

Sulfureous Water Therapy in Viral Respiratory Diseases

Completed NA Last updated 6 March 2024

What this trial tests

NA trial testing Inhalation of Sulfurous Thermal Water in Long-COVID in 30 participants. Completed in 30 September 2023.

Timeline

30 May 2023

Primary endpoint
1 August 2023

30 September 2023

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	30 May 2023
Primary completion	1 August 2023
Estimated completion	30 September 2023
Sites	1 location across Italy

Drugs / interventions tested

• Inhalation of Sulfurous Thermal Water
• Inhalation of Sterile Distilled non-pyrogenic Water

Conditions studied

• Long-COVID — all drugs for Long-COVID →
• Post COVID-19 Condition — all drugs for Post COVID-19 Condition →
• Chronic COVID-19 Syndrome — all drugs for Chronic COVID-19 Syndrome →
• Post Acute Sequelae of COVID-19 — all drugs for Post Acute Sequelae of COVID-19 →

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 75, any sex, with Long-COVID or Post COVID-19 Condition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.

The main questions it aims to answer are:

* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)
* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)
* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)
* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.

Both arms will be tested for:

* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)
* spirometry (resting, forced, DLCO)
* exertion response (6 minutes walking test)
* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).

Researchers will compare results reported by STW to those of SDW group to see if significative differences are detectable.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of sulphur thermal water inhalations in long-COVID syndrome: Spa-centred, double-blinded, randomised case-control pilot study.
   Crucianelli S, Mariano A, Valeriani F, Cocomello N, et al · · 2024 · cited 5× · PMID 39370044 · DOI 10.1016/j.clinme.2024.100251
2. Atti 57° Congresso Nazionale Società Italiana Igiene, Medicina Preventiva e Sanità Pubblica (SItI): Palermo, 23-26 ottobre 2024.
   · 2025 · PMID 40757101 · DOI 10.15167/2421-4248/jpmh2026.66.1s1