Hypertonic Saline Nasal Irrigation and Gargling (HSNIG) for Suspected COVID-19 in Pakistan
HSNIG
1 other identifier
interventional
405
1 country
1
Brief Summary
Nasal washing (washout) followed by gargles with hypertonic saline (HSNIG) is believed to be effective in reducing the duration of illness in those with clinically suspected or confirmed COVID-19 being managed at home, and also is effective in reducing complications of COVID-19 and onward household transmission. This study plans to investigate whether the use of HSNIG performed by adults with symptoms consistent with COVID-19 reduces the duration of symptoms when compared to participants managed using standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedNovember 3, 2021
November 1, 2021
7 months
October 25, 2021
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time to resolution of symptoms
Self-reported time to resolution as assessed by completion of the validated self-reported UK-adapted short form of the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) which will be used to collect daily symptom data
2 weeks
Study Arms (2)
Intervention
EXPERIMENTALIntervention Group HSNIG started within 5 days of symptom onset Number of times HSNIG should be done: As many times as needed (but not more than 12 times/day) PLUS Standard personal, household hygiene and social distancing advice: http://www.covid.gov.pk/prevention
Control
PLACEBO COMPARATORControl Group Standard personal, household hygiene and social distancing advice: http://www.covid.gov.pk/prevention
Interventions
Nasal washout and gargles
Eligibility Criteria
You may qualify if:
- Adults (≥18 years)
- Those living within larger cities of Pakistan (for laboratory access)
- Those self-isolating at home within 5 days of the start of the illness with:
- Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the following symptoms: Respiratory symptoms, such as cough and shortness of breath; Fever; Muscle pain; Headache; Sore throat; New loss of taste or smell; Severe fatigue; Nausea or vomiting; Diarrhoea and Congestion or runny nose OR
- Those with virologically confirmed SARS-CoV-2 infection and clinical symptoms indicative of COVID-19 (as detailed in (a) above).
- Provision of informed consent
You may not qualify if:
- Onset of illness (symptoms) more than 5 days
- Inability to consent
- Age less than 18 years.
- Pregnancy
- Immunosuppressed patients Inability to perform HSNIG
- Those taking part in another interventional medical trial
- Those with suspected/confirmed COVID-19 in whom hospital admission is recommended
- Those who do not have access to email / internet
- Those living in a household with another person currently participating in this study
- Those who have not provided consent to take part
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Allergy and Asthma Institute, Pakistan
Islamabad, 44000, Pakistan
Related Publications (1)
Yusuf OM, Ramalingam S, Norrie J, Graham C, Kakakhail A, Rextin AT, Baig RT, Yusuf SO, Ahmad B, Zahra S, Sheikh A. Hypertonic saline nasal irrigation and gargling for suspected or confirmed COVID-19: Pragmatic randomised controlled trial (ELVIS COVID-19). J Glob Health. 2024 Dec 13;14:05027. doi: 10.7189/jogh.14.05027.
PMID: 39666578DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aziz Sheikh, MD, PhD
University of Edinburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Consultant
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 3, 2021
Study Start
May 1, 2021
Primary Completion
November 15, 2021
Study Completion
November 30, 2021
Last Updated
November 3, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share
The study is anonymized, and individual participant data (IPD) will not be available to other researchers.