Clinical trial NCT04743349: Steam Inhalations in COVID-19 Patients
Official title: Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Coronavirus Infection
Coronavirus
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in viral shedding
timeFrame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
Secondary outcomes:
measure: Clinical outcome
timeFrame: From date of randomization until the date of first documented clinical improvement from any cause assessed up to 9 months"
measure: Negativization rate
timeFrame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
Other outcomes:
measure: Viral load measurement
timeFrame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital
Study officials:
References: