protocolSection identificationModule nctId: NCT06294756, orgStudyIdInfo id: acquealbuleroma1, secondaryIdInfos id: AR1221816703484E, type: OTHER_GRANT, domain: La Sapienza University, Rome, Italy, briefTitle: Sulfureous Water Therapy in Viral Respiratory Diseases, acronym: STWandRVD, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, collaborators name: Università degli studi di Roma Foro Italico, collaborators name: Queen Mary University of London, collaborators name: Bios Prevention Srl, descriptionModule briefSummary: 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., conditionsModule conditions: Long-COVID, conditions: Post COVID-19 Condition, conditions: Chronic COVID-19 Syndrome, conditions: Post Acute Sequelae of COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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 eligible subjects were randomized in a 1:1 ratio to either: active (STW) or placebo (SDW) group for the inhalation therapy and tested at 3 timepoints: Visit 1 (prior treatment), Visit 2 (just after treatment), Visit 3 (3 months after treatment)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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 participant's analyses were aware of the study intervention received (STW vs SDW). A randomization list (1:1 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., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Inhalation of Sulfurous Thermal Water, interventions name: Inhalation of Sterile Distilled non-pyrogenic Water, outcomesModule primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters., primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters., primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, primaryOutcomes measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID, secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients., secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, secondaryOutcomes measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection, otherOutcomes measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire, otherOutcomes measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acque Albule, Terme di Roma, city: Tivoli, state: Rome, zip: 00019, country: Italy, geoPoint lat: 41.95952, lon: 12.8016, hasResults: False