Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
143 participants
INTERVENTIONAL
2021-01-26
2021-06-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental arm
Steam inhalations
Steam inhalations
Exposure of airway mucosae to humidified steam through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.
Control arm
No intervention
No interventions assigned to this group
Interventions
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Steam inhalations
Exposure of airway mucosae to humidified steam through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects with severe asthma
* Subjects and with contraindications to treatment with steam inhalations
* Multi-allergic subjects
* Subjects unable to complete the protocol
18 Years
100 Years
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Giancarlo la Marca
Pharm Sc
Locations
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Meyer Children's Hospital
Florence, , Italy
Countries
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Other Identifiers
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Steam-COVID
Identifier Type: -
Identifier Source: org_study_id
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