Hypertonic Saline for COVID-19 Symptoms

NCT04465604 | Unknown

• 2 other identifiers: RAC # 2201072H-01-R-007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Coronavirus disease 2019 (COVID-19) is spreading rapidly in the world with no proven effective therapy to date. Some patients with COVID-19 develop sever respiratory disease requiring ICU care. There is in vitro evidence that hypertonic saline (HTS) may be beneficial in reducing the inflammatory component in similar viral illnesses. Objective: To assess whether wearing a face mask sprayed with HTS (in addition to other COVID-19 treatments) leads to decreasing the severity of the respiratory symptoms resulting from COVID-19. Study design: Multi-centre trial Study population: Any patient older than 18 years of age with confirmed COVID-19 diagnosis who has any of the following respiratory symptoms or signs:

• cough,
• shortness of breath,
• tachypnea (respiratory rate of 20 breaths / minute or more),
• hypoxemia (O2 saturation 90% or less on room air) Intervention: Participants will be asked to wear a face mask for 20-30 minutes every 6 hours for the duration of their respiratory symptoms and/or signs. This inside surface of the face mask will be sprayed with 10-15 ml of HTS and allowed to air dry before the participant is permitted to wear it. A new face mask will be given to the patient every 24 hours. All participants will continue to receive their other COVID-19 treatments as per local hospital guidelines. Main study parameter: Improvement of the respiratory symptoms and signs on repeated measurement. Nature and extent of the burden and risks associated with participation, benefit: The burden of COVID-19 is very severe world wide. The trial duration is 3 months, with potential extension if deemed needed by interim analysis at the end of 3 months. There are no additional risks for participation in this study as only face masks will be used with no additional medications being given to the participants. In the future, the results of this study could lead to improved care for COVID-19 patients.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Improvement of respiratory symptoms

  Cough and / or shortness of breath

  Throughout hospital stay on average 21 days

• Improvement of respiratory signs

  Respiratory rate and / or need for supplemental oxygen

  Throughout hospital stay on average 21 days

Secondary Outcomes (2)

• ICU admission

  Throughout hospital stay on average 21 days

• Mechanical ventilation

  Throughout hospital stay on average 21 days

Interventions

Wearing surgical face mask sprayed with hypertonic saline OTHER

The inner surface of a standard surgical face mask will sprayed by 10 to 15 ml of HTS (6% w/v Saline solution prepared by adding 6 gram NaCl to 100 ml of water if not commercially available) and allowed to air dry. The participant will wear the face mask for 20-30 minutes every 6 hours until discharge, intubation for mechanical ventilation or death. A new HTS sprayed mask will be worn by the participant every 24 hours. The data items will be collected on daily basis

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• confirmed diagnosis of COVID-19 by PCR and
• Any of the following
• cough
• shortness of breath
• Respiratory rate more than 20 per minute or
• oxygen saturation 90% or less on room air

You may not qualify if:

• Age younger than 18 years
• Pregnancy
• Participation in other COVID-19 intervention trial

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ali Alshanqeeti, MD

  King Faisal Specialsit Hospital and Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Alshanqeeti, MD

CONTACT

+966114427094; ashanqeeti@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample size was based on the following assumptions: Poor response rate to HTS is set at 10% or less; Good response to HTS is set at 30% or more ;One-sided Alph error probability is set to \< 0.05 (i.e. p \< 0.05) and Power to detect rate difference between good response and poor response to HTS is at least 80%. Using the Fleming single-arm group-sequential design (Fleming 1982) Based on these assumptions; a sample size of N=25 patients is expected to achieve a power of 84% of detecting enough activity by HTS (p\<0.05 one-sided) of improving respiratory parameters of COVID19 patients. This will be achieved if the true remission rate difference between a poor and good HTS is 20%. Considering the dropout rate of 25%, a minimum of 50 patients will be enrolled. This will ensure more than 90% power to detect at least 20% positive effect of HTS

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 10, 2020
• Study Start: February 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)