COVID Clinical Trial
Official title:
Hypertonic Saline Nasal Irrigation and Gargling for Suspected or Confirmed COVID-19: Pragmatic Web-based Bayesian Adaptive Randomised Controlled Trial (ELVIS COVID-19)
NCT number | NCT04382131 |
Other study ID # | AC20042 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 23, 2020 |
Est. completion date | October 31, 2020 |
ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.
Status | Recruiting |
Enrollment | 405 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults (=18 years) - Those living within the UK - Those self-isolating at home within 48 hours of the start of the illness with: 1. Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the following symptoms: recent onset of (i) new continuous cough and/or (ii) high temperature) and/or (iii) loss of, or change in, sense of smell or taste (anosmia) OR 2. Those with virologically confirmed SARS-CoV-2 infection and clinical symptoms indicative of COVID-19 (as detailed in (a) above). - Provision of informed consent Exclusion Criteria: - Onset of illness>48 hours - Inability to consent - Pregnancy - Immunosuppression - Inability to perform HSNIG - Those taking part in another interventional medical trial - Those without access to a supply of salt - Those who have had a negative COVID-19 swab result for the present symptoms - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Lothian | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'. | Time until participant reports well | Maximum of 14 days | |
Secondary | Severity of all symptoms | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | |
Secondary | The length of time for individual symptoms to resolve | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | |
Secondary | Severity of individual symptoms | Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe) | 1-14 days or until the participant reports that they are well | |
Secondary | Contacting healthcare (NHS 24, OOH, GP) | Number of participants and frequency of contacts | 1-14 days or until the participant reports that they are well | |
Secondary | Participants needing GP appointments | Number of participants and frequency of contacts | 1-14 days or until the participant reports that they are well | |
Secondary | Participants attending hospital | Number of participants | 1-14 days or until the participant reports that they are well | |
Secondary | Length of stay in hospital if admitted | Number of days | 1-14 days or until the participant reports that they are well | |
Secondary | Number of participants reporting over the counter medication use | Number of participants | 1-14 days or until the participant reports that they are well | |
Secondary | Reduction in transmission to household contacts | Number of people within participant's household who develop symptoms | 1-14 days or until the participant reports that they are well | |
Secondary | Number of participants reporting side effects of nasal irrigation | Number of participants in intervention arm reporting side effects | 1-14 days or until the participant reports that they are well | |
Secondary | Types and severity of side effects reported | Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe' | 1-14 days or until the participant reports that they are well | |
Secondary | Cost of over the counter medication used | Estimated cost requested when participant states over the counter medication used | 1-14 days or until the participant reports that they are well |
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