Steam Inhalations in COVID-19 Patients (Steam-COVID)

August 24, 2022 updated by: Giancarlo la Marca, Meyer Children's Hospital

Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50139
        • Meyer Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Steam inhalations
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.
No Intervention: Control arm
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in viral shedding
Time Frame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
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
Time Frame: From date of randomization until the date of first documented clinical improvement from any cause assessed up to 9 months"
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
Time Frame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load measurement
Time Frame: From date of randomization until the date of first documented negativization from any cause assessed up to 9 months
Measurement expressed in pg / mL of the mean values of the viral load measured in the treated group compared to the untreated group at the different monitoring times
From date of randomization until the date of first documented negativization from any cause assessed up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

June 6, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steam-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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