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

• ClinicalTrials.gov Identifier: NCT04743349
• Recruitment Status: Terminated
• First Posted: February 8, 2021
• Last Update Posted: August 29, 2022
• Sponsor: Meyer Children's Hospital IRCCS
• Information provided by (Responsible Party): Giancarlo la Marca, Meyer Children's Hospital IRCCS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19; Coronavirus Infection; Coronavirus	Procedure: Steam inhalations	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients
• Actual Study Start Date: January 26, 2021
• Actual Primary Completion Date: May 15, 2021
• Actual Study Completion Date: June 6, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Meyer Children's Hospital

Florence, Italy, 50139

Sponsors and Collaborators

Meyer Children's Hospital IRCCS

More Information

• Responsible Party: Giancarlo la Marca, Pharm Sc, Meyer Children's Hospital IRCCS
• ClinicalTrials.gov Identifier: NCT04743349
• Other Study ID Numbers: Steam-COVID
• First Posted: February 8, 2021
• Last Update Posted: August 29, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases