SARS-CoV InfectionSITCOVNCT04730661
Efficacy of the Sit to Stand Test in the Decision to Hospitalize a Patient Consulting the Emergency Dept for COVID 19
A study testing Sit to stand test in people with SARS-CoV Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- Sit to stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2020to 2 Jun 2021
- 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
- Adult (≥18 years old)
- Admit to emergency department for suspected SARS-Cov2 infection
- SARS-CoV2 infection confirmed by Real Time Polymerase Chain Reaction (RT - PCR) before the first discharge of emergency department
- Patient affiliated or beneficiary of a health care insurance
- Effective contraception in women of childbearing age. For postmenopausal women, amenorrhea for at least 12 months before the inclusion visit
Who cannot join
- Patient presenting criteria for admission to intensive care: signs of acute respiratory distress , respiratory rate> 30 / min, oxygen dependence > 6L / min on face mask for an SpO2 ≥ 95% or an arterial oxygen pressure >8kPa, neurological disorders, systolic blood pressure (SBP) <90mmHg despite fluid resuscitation, lactates> 2mmol / L, bradycardia, or heart rate disorders
- Patient with SpO2 <90% in spontaneous ventilation in room air at rest
- Patient with functional impairment or deterioration of the general condition leading to the inability to perform STST
- Patient with a resting SBP> 180 mmHg or resting diastolic blood pressure (DBP)> 100 mmHg or resting heart rate (HR)> 120 / min
- Patient with decompensated or unbalanced cardiac pathology
- Patient previously included in the study following a previous admission to emergency department
- Patient deprived of liberty, unable to consent freely
- Patient non affiliated or beneficiary of a health care insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Sit to Stand Test (STST) in the Decision to Hospitalize a Patient Consulting the Emergency Department for COVID 19 (Coronavirus Infectious Disease)
As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent specialized care. Therefore, it is essential to develop emergency assessment tools to assess relevant criteria to decide which patients must be kept under hospital monitoring and which patients can be treated on outpatient care.
The aim of this study is to assess the efficacy of STST in the decision to hospitalize patients consulting emergency department for a SARS-Cov2 infection. The investigators wish to show that the addition of this test to the usual hospitalization criteria reduces the proportion of patients hospitalized 48 hours after their first visit to the emergency department.
- Conditions
- SARS-CoV Infection
- Being tested
- Sit to stand test
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit to stand testDiagnostic test
The sit to stand test (or STST) is a test consisting of performing as many sit-to-stand tests as possible in one minute, from a chair without armrests.
We note before and during this test, the SpO2 (pulsed oxygen saturation) (rest value and minimum value during exercise), heart rate (HR), dyspnea on the modified Borg scale as well as the number of chair lifts performed. completely and minimum SpO2 during the recovery phase.
The possible results from this one-minute test are as follows:
- If SpO2 <90% or appearance of signs of respiratory distress: Immediate stop of the test and hospitalization
- SpO2 <90% or decrease in SpO2 ≥ 4% during the test or during the recovery period: Hospitalization
- SpO2 ≥90% and no decrease in SpO2 ≥ 4% during the test or during the recovery period which will be 3 minutes maximum: discharge.
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | No intervention | For the patients enrolled in this conventional arm, the decision of hospitalisation or discharge will be taken with usual criteria (pulsed oxygen saturation (SpO2) in room air <92% and respiratory rate> 22/min, respiratory rate> 30/min, Blood gas hypoxemia, decompensation of comorbidity, home monitoring not possible, other intercurrent pathology requiring hospitalization, several risk factors for COVID infection requiring hospitalization in intensive care (age> 65y, hypertension complicated by a cardiovascular event, chronic cardiovascular disease, unbalanced diabetes with complications, chronic respiratory disease (excluding well-controlled asthma), chronic renal failure dialysis, obesity, progressive cancer under treatment, congenital or acquired immunosuppression) |
| Interventional arm | Experimental | For the patients enrolled in this interventional arm, the decision of hospitalisation or discharge will be taken with usual criteria and the result of Sit to Stand Test. Receives: Diagnostic Test: Sit to stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
Measured: 7 days
Secondary outcomes (6)
Proportion of immediate hospitalizations after the 1st admission at emergency department.
Measured: 7 days
Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.
The adverse events identified are:
- medical consultation,
- readmission to the emergency department,
- hospitalization,
- hospitalization in intensive care unit,
- death.
Measured: 7 days
Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.
The adverse events identified are:
- medical consultation,
- readmission to the emergency department,
- hospitalization,
- hospitalization in intensive care unit,
- death.
Measured: 7 days
Correlation between SpO2 and the occurrence of an adverse event
the difference between the measurement of SpO2 before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Measured: 7 days
Correlation between heart rate (HR) and the occurrence of an adverse event
the difference between the measurement of HR before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Measured: 7 days
Correlation between dyspnea score and the occurrence of an adverse event
the difference between the measurement of dyspnea score before and after STST will be used to establish the correlation between this difference and the occurrence of an adverse event.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start21 Dec 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Why it stopped: decrease of inclusion capacities because of the control of COVID 19 epidemia thanks to vaccination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise ARTAUD-MACARI, MD, Principal investigator, Pneumology, Thoracic Oncology and Respiratory Intensive Care UnitFairuz BOUJIBAR, PhD, Study director, Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730661
- Sponsor's protocol ID
- 2020/0339/HP
- Acronym
- SITCOV
- Status last verified
- Nov 2022
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Sit to Stand Test (STST) in the Decision to Hospitalize a Patient Consulting the Emergency Department for COVID 19 (Coronavirus Infectious Disease)
- ClinicalTrials.gov ID
- NCT04730661
- Acronym / sponsor ID
- SITCOV / 2020/0339/HP
- Conditions
- SARS-CoV Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decrease of inclusion capacities because of the control of COVID 19 epidemia thanks to vaccination
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 29 Jan 2021 (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.
As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent specialized care. Therefore, it is essential to develop emergency assessment tools to assess relevant criteria to decide which patients must be kept under hospital monitoring and which patients can be treated on outpatient care.
The aim of this study is to assess the efficacy of STST in the decision to hospitalize patients consulting emergency department for a SARS-Cov2 infection. The investigators wish to show that the addition of this test to the usual hospitalization criteria reduces the proportion of patients hospitalized 48 hours after their first visit to the emergency department.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | No intervention | –For the patients enrolled in this conventional arm, the decision of hospitalisation or discharge will be taken with usual criteria (pulsed oxygen saturation (SpO2) in room air <92% and respiratory rate> 22/min, respiratory rate> 30/min, Blood gas hypoxemia, decompensation of comorbidity, home monitoring not possible, other intercurrent pathology requiring hospitalization, several risk factors for COVID infection requiring hospitalization in intensive care (age> 65y, hypertension complicated by a cardiovascular event, chronic cardiovascular disease, unbalanced diabetes with complications, chronic respiratory disease (excluding well-controlled asthma), chronic renal failure dialysis, obesity, progressive cancer under treatment, congenital or acquired immunosuppression) |
| Interventional arm | Experimental | Diagnostic Test: Sit to stand testFor the patients enrolled in this interventional arm, the decision of hospitalisation or discharge will be taken with usual criteria and the result of Sit to Stand Test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (≥18 years old)
- Admit to emergency department for suspected SARS-Cov2 infection
- SARS-CoV2 infection confirmed by Real Time Polymerase Chain Reaction (RT - PCR) before the first discharge of emergency department
- Patient affiliated or beneficiary of a health care insurance
- Effective contraception in women of childbearing age. For postmenopausal women, amenorrhea for at least 12 months before the inclusion visit
Key exclusion criteria (8 listed)
- Patient presenting criteria for admission to intensive care: signs of acute respiratory distress , respiratory rate> 30 / min, oxygen dependence > 6L / min on face mask for an SpO2 ≥ 95% or an arterial oxygen pressure >8kPa, neurological disorders, systolic blood pressure (SBP) <90mmHg despite fluid resuscitation, lactates> 2mmol / L, bradycardia, or heart rate disorders
- Patient with SpO2 <90% in spontaneous ventilation in room air at rest
- Patient with functional impairment or deterioration of the general condition leading to the inability to perform STST
- Patient with a resting SBP> 180 mmHg or resting diastolic blood pressure (DBP)> 100 mmHg or resting heart rate (HR)> 120 / min
- Patient with decompensated or unbalanced cardiac pathology
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 |
|---|---|---|
| Sit to stand testThe sit to stand test (or STST) is a test consisting of performing as many sit-to-stand tests as possible in one minute, from a chair without armrests. We note before and during this test, the SpO2 (pulsed oxygen saturation) (rest value and minimum value during exercise), heart rate (HR), dyspnea on the modified Borg scale as well as the number of chair lifts performed. completely and minimum SpO2 during the recovery phase. The possible results from this one-minute test are as follows: * If SpO2 <90% or appearance of signs of respiratory distress: Immediate stop of the test and hospitalization * SpO2 <90% or decrease in SpO2 ≥ 4% during the test or during the recovery period: Hospitalization * SpO2 ≥90% and no decrease in SpO2 ≥ 4% during the test or during the recovery period which will be 3 minutes maximum: discharge. | Diagnostic test | Interventional arm |
Primary outcome
Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection.
Time frame: 7 days
6 secondary outcomes
Proportion of immediate hospitalizations after the 1st admission at emergency department.
Time frame: 7 days
Proportion of adverse events related to SARS-Cov2 infection within 7 days of patient inclusion.
Time frame: 7 days
Establish the correlation between the number of chair rises performed on STST and the occurrence of an adverse event.
Time frame: 7 days
Correlation between SpO2 and the occurrence of an adverse event
Time frame: 7 days
Correlation between heart rate (HR) and the occurrence of an adverse event
Time frame: 7 days
Correlation between dyspnea score and the occurrence of an adverse event
Time frame: 7 days
Results and safety
The study was stopped early (reason given: decrease of inclusion capacities because of the control of COVID 19 epidemia thanks to vaccination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- 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.
Elise ARTAUD-MACARI, MD principal investigator
Pneumology, Thoracic Oncology and Respiratory Intensive Care Unit
Fairuz BOUJIBAR, PhD study director
Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit to stand test in people with SARS-CoV Infection, run by University Hospital, Rouen at 1 site in France.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Jan 2026. 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 France. 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 was stopped early (reason given: decrease of inclusion capacities because of the control of COVID 19 epidemia thanks to vaccination). Results are not available in the source record.
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?
Proportion of late hospitalizations, within 48 hours of first discharge from emergency department, and motivated by worsening symptoms secondary to SARS-Cov2 infection. (time frame: 7 days). 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 22 Jan 2026.