Trials / Terminated
TerminatedNCT04743349
Steam Inhalations in COVID-19 Patients
Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- Meyer Children's Hospital IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
Timeline
- Start date
- 2021-01-26
- Primary completion
- 2021-05-15
- Completion
- 2021-06-06
- First posted
- 2021-02-08
- Last updated
- 2022-08-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04743349. Inclusion in this directory is not an endorsement.