Clinical Trials Directory

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

TypeNameDescription
PROCEDURESteam inhalationsExposure 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.