Steam Inhalations in COVID-19 Patients

NCT04743349 | Terminated

• 1 other identifier: Steam-COVID
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Coronavirus Infection; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Reduction in viral shedding

  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 Outcomes (2)

• Clinical outcome

  From date of randomization until the date of first documented clinical improvement from any cause assessed up to 9 months"

• Negativization rate

  From date of randomization until the date of first documented negativization from any cause assessed up to 9 months

Other Outcomes (1)

• Viral load measurement

  From date of randomization until the date of first documented negativization from any cause assessed up to 9 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

Steam inhalations

Procedure: Steam inhalations

Control arm

NO INTERVENTION

No intervention

Interventions

Steam inhalations PROCEDURE

Exposure of airway mucosae to humidified steam through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital

Florence, 50139, Italy

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm Sc

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 8, 2021
• Study Start: January 26, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 6, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)