Steam Inhalations in COVID-19 Patients

Covid19 Clinical Trial

— Steam-COVID  

Official title:

Steam Inhalations in Asymptomatic and Paucisymptomatic COVID-19 Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04743349
• Other study ID #: Steam-COVID
• Status: Terminated
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: June 6, 2021

Study information

• Verified date: August 2022
• Source: Meyer Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 143
• Est. completion date: June 6, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral load measurement	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
Primary	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	Clinical outcome	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"
Secondary	Negativization rate	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