Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294756
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-09
Brief Title:
Sulfureous Water Therapy in Viral Respiratory Diseases
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Effects of Sulfurous Thermal Waters Inhalations on Long-COVID Syndrome a Double-blinded Interventional Randomized Case-control Pilot Study on a Spa Centered Rehab Program
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STWandRVD
Brief Summary:
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 2right 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
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 2right 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
Detailed Description:
The study is a double-blind interventional randomized case-control pilot trial assessing the efficacy of sulfureous thermal water STW inhalations in patients diagnosed with long-COVID The study was performed from May to October 2023 at the Acque Albule spa facility Terme di Roma Tivoli Terme Rome Italy The SPA-center rehab program included 12 consecutive sessions for 20 minutes each from day 1 for 12 days Re-assessment of study analyses was performed on day 14 after Visit 2 The follow-up Visit 3 was 90 days after Visit 1
Eligible subjects were adult outpatients presenting to the spa facility with an independent prescription of inhalation therapy with sulfurous water for post-COVID respiratory issues The participants had previously tested positive in certified PCR screening for SARS-Cov-2 infection data from the Regional Archive of Health Service for SARS-Cov-2 Infection and at the time of the study had a positive diagnosis of long-COVID syndrome with pulmonary involvement
Neither the participants nor any of the medical researchers or laboratory staff involved in the screening enrolment clinical evaluation monitoring and laboratory as well as statistics of the participants analyses were aware of the study intervention received STW vs SDW A randomization list 11 active vs placebo was created prior to recruiting The inhalation assistant randomized the participant according to the list and administered the intervention Therefore the inhalation assistant was unblinded to the treatment assigned but blinded to the medical condition of the participants
At each session of treatment delivered at Visit 1 and Visit 2 participants were tested for SARS-Cov-2 infection underwent resting plus forced spirometry and alveolar-capillary diffusion of carbon monoxide DLCO spirometry and performed the the six minutes walking test 6MWT St George Respiratory Questionnaire SGQ used to determine the impact of pulmonary impairment on the quality of life was completed at Visit 1 and Visit 3 patient satisfaction survey was submitted to participants at Visit 3 only Moreover blood samples for routine analysis urine sample collections and nasal swabs for microbiome sampling were collected at each visit At the end of Visit 1 screeningenrolment day the eligible subjects were randomized in a 11 ratio to either active STW or placebo SDW group for the inhalation therapy Both active and controls underwent inhalation therapy once a day for 12 days from day 1
Eligible subjects were adult outpatients presenting to the spa facility with an independent prescription of inhalation therapy with sulfurous water for post-COVID respiratory issues The participants had previously tested positive in certified PCR screening for SARS-Cov-2 infection data from the Regional Archive of Health Service for SARS-Cov-2 Infection and at the time of the study had a positive diagnosis of long-COVID syndrome with pulmonary involvement
Neither the participants nor any of the medical researchers or laboratory staff involved in the screening enrolment clinical evaluation monitoring and laboratory as well as statistics of the participants analyses were aware of the study intervention received STW vs SDW A randomization list 11 active vs placebo was created prior to recruiting The inhalation assistant randomized the participant according to the list and administered the intervention Therefore the inhalation assistant was unblinded to the treatment assigned but blinded to the medical condition of the participants
At each session of treatment delivered at Visit 1 and Visit 2 participants were tested for SARS-Cov-2 infection underwent resting plus forced spirometry and alveolar-capillary diffusion of carbon monoxide DLCO spirometry and performed the the six minutes walking test 6MWT St George Respiratory Questionnaire SGQ used to determine the impact of pulmonary impairment on the quality of life was completed at Visit 1 and Visit 3 patient satisfaction survey was submitted to participants at Visit 3 only Moreover blood samples for routine analysis urine sample collections and nasal swabs for microbiome sampling were collected at each visit At the end of Visit 1 screeningenrolment day the eligible subjects were randomized in a 11 ratio to either active STW or placebo SDW group for the inhalation therapy Both active and controls underwent inhalation therapy once a day for 12 days from day 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AR1221816703484E | OTHER_GRANT | La Sapienza University Rome Italy | None |