COVID, Upper Respiratory Tract Infections, Virus, Virus Diseases, Virus Shedding
Conditions
Brief summary
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.
Detailed description
COVID-19, a recently identified disease, has spread worldwide rapidly and is now a pandemic. There is no cure for it yet. Though it causes mild to moderate illness in most people, it can cause serious illness and death, particularly in the elderly, those with chronic illness or a weakened immune system. The ELVIS COVID-19 study is to find out if nasal washout (i.e. irrigation) and gargling with salt water (hypertonic saline) helps individuals with COVID-19 get better faster. Preliminary data from those with the common cold has found that nasal washouts and gargling with salty water may be helpful in reducing the length of the illness. This trial will help us find out if the same treatment is helpful in improving COVID-19 symptoms and preventing the spread of the disease. After self-consenting online, participants will be randomised into one of two study groups. The control group will be given standard personal, household hygiene and social distancing advice. The intervention group will be taught using online videos how to prepare and perform hypertonic saline nasal irrigation and gargling (HSNIG) up to 12 times daily in addition to standard advice. Participants in both the intervention and control groups will complete an online daily diary first thing in the morning, which will be sent to them via an email link. The diaries will be completed every day until the participant reports they are well or for a maximum of 14 days or participant withdrawal.This study will look for participants across Scotland, who are 18 years old or older and who are self-isolating with confirmed or suspected COVID-19, with symptoms that have developed no more than 48 hours before consent to the study. The study is conducted online and everything we ask participants to do will be done at home with items they will already have.
Interventions
OTHERNaCl Solution
NaCl Solution prepared by participants at home using water and salt
Sponsors
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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. Participants from Scotland will be self-recruiting via web based system which will randomise in a 1:1 ratio to perform HSNIG or not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resolution of Symptoms as Defined by the Single Question 'How Unwell do You Feel Today'. | Maximum of 14 days | Time until participant reports well |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Side Effects of Nasal Irrigation | 1-14 days or until the participant reports that they are well | Number of participants in intervention arm reporting side effects |
| Severity of All Symptoms | 1-14 days or until the participant reports that they are well | 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). Participants asked 'How unwell do you feel today?' on this scale |
| The Length of Time for Individual Symptoms to Resolve | 1-14 days or until the participant reports that they are well | 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) |
| Severity of Individual Symptoms | 1-14 days or until the participant reports that they are well | 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) |
| Contacting Healthcare (NHS 24, OOH, GP) | 1-14 days or until the participant reports that they are well | Number of participants who contacted healthcare services during the study period |
| Participants Needing GP Appointments | 1-14 days or until the participant reports that they are well | Number of participants and frequency of contacts |
| Participants Attending Hospital | 1-14 days or until the participant reports that they are well | Number of participants |
| Length of Stay in Hospital if Admitted | 1-14 days or until the participant reports that they are well | Number of days |
| Number of Participants Reporting Over the Counter Medication Use | 1-14 days or until the participant reports that they are well | Number of participants |
| Types and Severity of Side Effects Reported | 1-14 days or until the participant reports that they are well | 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' |
| Change in Transmission to Household Contacts | 1-14 days or until the participant reports that they are well | Number of participants who reported transmission to other members of their household the study period |
| Cost of Over the Counter Medication Used | 1-14 days or until the participant reports that they are well | Estimated cost requested when participant states over the counter medication used |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORAziz Sheikh
University of Edinburgh
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.89 years STANDARD_DEVIATION 13.28 |
| Age, Customized <50 | 11 Participants |
| Age, Customized 50 to 70 | 1 Participants |
| Height | 1.74 meters STANDARD_DEVIATION 0.1 |
| Race/Ethnicity, Customized Asian/Asian British | 0 Participants |
| Race/Ethnicity, Customized Mixed/multiple ethnic groups | 1 Participants |
| Race/Ethnicity, Customized White | 8 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
| Smoke Current | 1 Participants |
| Smoke Former | 4 Participants |
| Smoke Never | 4 Participants |
| Weight | 76.05 kg STANDARD_DEVIATION 19.16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 1 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
None listed