Steam Inhalations in COVID-19 Patients

Study Overview
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Brief Summary
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The new coronavirus (SARS-CoV-2) causing COVID-19 is an RNA virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. The external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways. Since high temperature can cause irreversible denaturation of proteins and loss of SARS CoV and SARS CoV-2 infectivity was obtained after heating at 56 ◦C for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging SARS-CoV-2 capsid through steam inhalation cycles. Although the ominous consequences of COVID 19 infections has directed medical attention toward solidly established medical approaches, the European Pharmacopoeia VI edition also quotes steam inhalations as a procedure to treat of respiratory diseases. Based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a SARS-CoV-2 infection. The study protocol consisted of exposure of airway mucosae to humidified steam (pH 8 per NaHCO3 and hypertonic 15 g/L NaCl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days. The objective of the study is to reduce the viral shedding using steam inhalations.

Official Title
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Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients

Conditions
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Covid19, Coronavirus Infection, Coronavirus

Intervention / Treatment
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* Procedure: Steam inhalations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with a SARS-CoV-2 positive molecular swab carried out in the previous 48 hours before the enrollement Adults with mild infection Adults with symptoms such as fever above 37 ° C, feeling bad, cold symptoms (cough, pharyngodynia, nasal congestion), headache, myalgia, diarrhea, anosmia, dysgeusia Adults without the above symptoms Exclusion Criteria: Adults with dyspnea and/or dehydration and/or alterations in consciousness and/or sepsis. Subjects with severe asthma Subjects and with contraindications to treatment with steam inhalations Multi-allergic subjects Subjects unable to complete the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Steam inhalations | Procedure: Steam inhalations<br>* Exposure of airway mucosae to humidified steam through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.<br>|
| No Intervention: Control arm<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in viral shedding | Difference / ratio between the percentage of subjects with negative swab 10 days after enrollment in the treated group and the percentage in the non-treated group. | From date of randomization until the date of first documented negativization from any cause assessed up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Difference / ratio between the percentage of subjects with residual symptoms after 10 days of enrollment in the treated group and the percentage of subjects with residual symptoms after 10 days of enrollment in the untreated group (only for the subgroup of patients with severe symptoms). | From date of randomization until the date of first documented clinical improvement from any cause assessed up to 9 months | 
| Negativization rate | Ratio between the incidence of the negativization rate (number of events / total person days) in the treated group and the incidence of the negativization rate in the untreated group. | From date of randomization until the date of first documented negativization from any cause assessed up to 9 months |