Sars-CoV2NCT04373161
Home Pulse Oximeter Use in Patients With COVID-19
A study testing Home Pulse Oximetry Monitoring in people with Sars-CoV2 and COVID-19, run by Swedish Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with COVID-19 to trend disease progression and identify need for hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Home Pulse Oximetry Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected COVID-19 as defined by the World Health Organization
- Age > 18
Who cannot join
- Pregnancy
- Prisoners
- Lack of decision making capacity or cannot provide consent
- Patients being admitted to the hospital
- Patients on home oxygen
- Patients being discharged to a skilled nursing facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
The purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with COVID-19 to trend disease progression and identify need for hospitalization.
Read the detailed description
This protocol studies patients with suspected non-severe Corona Virus Disease (COVID-19) being discharged to home from an emergency department (ED) or outpatient testing center. Patients will be provided a portable fingertip home pulse oximeter that measures peripheral oxygen saturation (SpO2). Patients will be instructed to check their resting home oxygen saturation three times per day and record these findings. They will be instructed to return to the emergency room for sustained oxygen saturation below 92% or if their symptoms are worsening and they feel they need medical attention. Patients will be called once daily by the research team to collect data in real time. Patients will be monitored for seven days, and at the end of the seven day period, they will return the pulse oximeter as well as a spreadsheet of their home oximetry readings. The purpose is to see if home pulse oximetry identifies disease progression and need for hospitalization in patients with COVID-19. Additionally, there will be analysis of trends in home oximetry readings wand predictors of morbidity and mortality.
- Being tested
- Home Pulse Oximetry Monitoring
- Keywords
- Oximetry, Oximeter, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Pulse Oximetry MonitoringDevice
Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Suspected COVID-19 patients being discharged to home | Experimental | Patients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day. Receives: Device: Home Pulse Oximetry Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization in COVID-19 patients with low home SpO2
The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.
Measured: 7 days after enrollment
Secondary outcomes (7)
Trend in resting home pulse oximetry readings
The purpose of this outcome is to determine if home pulse oximetry readings abruptly drop, gradually decline, or stay level in patients with COVID-19
Measured: 7 days after enrollment
Timing of SpO2 <92%
This will evaluate if there is a correlation between the time of day with SpO2 readings below 92 percent in patients with suspected COVID-19.
Measured: 7 days after enrollment
Home pulse oximeter use effect on subsequent ED visits
The goal of this outcome is to see if patients enrolled in the study are reassured by use of home pulse oximeter monitoring and if this device prevents subsequent ED visits by patients
Measured: 7 days after enrollment
Reason for return to the Emergency Department
To see if patients who return to the ED and end up hospitalized did so for incidental finding of low home pulse oximetry or if it was for worsening symptoms
Measured: 7 days after enrollment
Hospitalization outcome - morbidity
The study will assess development of morbidity defined as intensive care unit admission, acute respiratory distress syndrome, and/or septic shock in patients with SpO2 <92%
Measured: Up to 21 days after enrollment
Hospitalization outcome - mortality
The study will assess mortality defined as death after admission to the hospital in patients with SpO2 <92%
Measured: Up to 21 days after enrollment
Median Length of Stay
The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED.
Measured: Up to 21 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start20 Mar 2020
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaushal Majmudar, Swedish Hospital
- Investigators
- Sonia Shah, DO, Study director, Swedish Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373161
- Sponsor's protocol ID
- 2020032301
- Status last verified
- May 2020
- First submitted
- 30 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
- ClinicalTrials.gov ID
- NCT04373161
- Acronym / sponsor ID
- 2020032301
- Keywords
- Oximetry, Oximeter, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Swedish HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with COVID-19 to trend disease progression and identify need for hospitalization.
Detailed description
This protocol studies patients with suspected non-severe Corona Virus Disease (COVID-19) being discharged to home from an emergency department (ED) or outpatient testing center. Patients will be provided a portable fingertip home pulse oximeter that measures peripheral oxygen saturation (SpO2). Patients will be instructed to check their resting home oxygen saturation three times per day and record these findings. They will be instructed to return to the emergency room for sustained oxygen saturation below 92% or if their symptoms are worsening and they feel they need medical attention. Patients will be called once daily by the research team to collect data in real time. Patients will be monitored for seven days, and at the end of the seven day period, they will return the pulse oximeter as well as a spreadsheet of their home oximetry readings. The purpose is to see if home pulse oximetry identifies disease progression and need for hospitalization in patients with COVID-19. Additionally, there will be analysis of trends in home oximetry readings wand predictors of morbidity and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected COVID-19 patients being discharged to home | Experimental | Device: Home Pulse Oximetry MonitoringPatients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with suspected COVID-19 as defined by the World Health Organization
- Age > 18
Key exclusion criteria (6 listed)
- Pregnancy
- Prisoners
- Lack of decision making capacity or cannot provide consent
- Patients being admitted to the hospital
- Patients on home oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Pulse Oximetry MonitoringPatients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms. | Device | Suspected COVID-19 patients being discharged to home |
Primary outcome
Hospitalization in COVID-19 patients with low home SpO2
Time frame: 7 days after enrollment
The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.
7 secondary outcomes
Trend in resting home pulse oximetry readings
Time frame: 7 days after enrollment
Timing of SpO2 <92%
Time frame: 7 days after enrollment
Home pulse oximeter use effect on subsequent ED visits
Time frame: 7 days after enrollment
Reason for return to the Emergency Department
Time frame: 7 days after enrollment
Hospitalization outcome - morbidity
Time frame: Up to 21 days after enrollment
Hospitalization outcome - mortality
Time frame: Up to 21 days after enrollment
Median Length of Stay
Time frame: Up to 21 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Shah, DO study director
Swedish Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Pulse Oximetry Monitoring in people with Sars-CoV2 and COVID-19, run by Swedish Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization in COVID-19 patients with low home SpO2 (time frame: 7 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.