COVID-19 PneumoniaEpCOTNCT05008380
Efficacy of the Early Prone-positioning in Hospitalized Patients With Mild Covid-19 Pneumonia
A study testing prone positioning in people with COVID-19 Pneumonia, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- prone positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 16 Aug 2021to 3 Aug 2022
- 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
- > 18 years
- positive PCR for Sars-Cov-2 Rna on any respiratory samples within 7 days from enrollment
- imaging positive for pulmonary involvement or clinical evidence of respiratory involvement ( new onest of hypoxemia with 02 <80mmHg or SpO2 < 94% in air or need for oxygen therapy in oreder to mantaine SpO2 > 93%.
- need of hospitalization
Who cannot join
- start of prone-positioning cycles before being enrolled in the study
- SpO2/FiO2 <200
- need of high-flow oxygen therapy (HFNC) or need of non-invasive ventilation and/or CPAP or indications for intubation and mechanical ventilation
- relative or absolute contraindications for prone positioning (eg facial fractures, advanced pregnancy, mental status alterations, spinal instability...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Controlled, Randomized Clinical Trial on the Efficacy of Early Prone-positioning in Patients With Mild Pneumonia Due to SARS-CoV-2
The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions.
Patients will be randomized on a 1:1 ratio and stratified based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
Read more
One branch of patients (interventional) will undergo standard of care treatment + prone-positioning cycles, the other one (controll) will undergo standard of care treatment alone.
Patients will be evaluated evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first).
Adverse events and concurrent medications will be noted as well.
The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods.
Read the detailed description
In this prospective, unicentred, open, controlled study, patients will be randomized on a 1:1 ratio using casual permutation blocks, identifying two branches of treatment: standard of care; standard of care + prone positioning. Patients will be stratified in 4 strata based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
In order to obtain statistical significance, the sample size will include 96 patients.
Patients in the SOC + prone-positioning branch will undergo cycles of prone-positioning following this scheme: 3-6 hours of prone-positioning twice a day. The actual length of the cycles will be registered during the study.
Data will be collected using a dedicated CRF, which will include recording of adverse events and concurrent medications.
Patients will be evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first). If dismissal occurs before day 28, a follow-up interview will be conducted in presence or on the phone to collect the remaining data.
The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods (Kaplan-Meier curves with log-rank test and Cox regression), while secondary outcomes will be evaluated using both survival-based methods and proportional odds model.
The occurrence of adverse events and the causes of withdrawal from the study in the two branches of treatment will be compared using chi-square test.
- Conditions
- COVID-19 Pneumonia
- Being tested
- prone positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positioningProcedure or surgery
3-6 hours of prone-positioning twice a day
| Study group | Role | What they receive |
|---|---|---|
| Standard of care + prone positioning | Experimental | Standard of care. Prone-positioning cycles as the following: 3-6 hours of prone-positioning twice a day. Receives: Procedure: prone positioning |
| Standard of care | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accomplishment of the end-points
the occurence of the first of the following end-points: death, start of high flow oxygen therapy, CPAP, meccanichal ventilation, P/F <200
Measured: 0-28 days
Secondary outcomes (6)
time of recovery
Measured: 0-28 days
time of weaning from oxygen
Measured: 0-28 days
variation of the clinical condition
Measured: 0-28 days
mortality
Measured: 0-28 days
number of adverse event
Measured: 0-28 days
number and duration of prone positioning cycles
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start16 Aug 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonfanti, University of Milano Bicocca
- Investigators
- Paolo Bonfanti, Principal investigator, asst-monza Ospedale San Gerardo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008380
- Sponsor's protocol ID
- 3772
- Acronym
- EpCOT
- Status last verified
- Oct 2022
- First submitted
- 16 Aug 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Controlled, Randomized Clinical Trial on the Efficacy of Early Prone-positioning in Patients With Mild Pneumonia Due to SARS-CoV-2
- ClinicalTrials.gov ID
- NCT05008380
- Acronym / sponsor ID
- EpCOT / 3772
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 17 Aug 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.
The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions.
Patients will be randomized on a 1:1 ratio and stratified based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
One branch of patients (interventional) will undergo standard of care treatment + prone-positioning cycles, the other one (controll) will undergo standard of care treatment alone.
Patients will be evaluated evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first).
Adverse events and concurrent medications will be noted as well.
The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods.
Detailed description
In this prospective, unicentred, open, controlled study, patients will be randomized on a 1:1 ratio using casual permutation blocks, identifying two branches of treatment: standard of care; standard of care + prone positioning. Patients will be stratified in 4 strata based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
In order to obtain statistical significance, the sample size will include 96 patients.
Patients in the SOC + prone-positioning branch will undergo cycles of prone-positioning following this scheme: 3-6 hours of prone-positioning twice a day. The actual length of the cycles will be registered during the study.
Data will be collected using a dedicated CRF, which will include recording of adverse events and concurrent medications.
Patients will be evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first). If dismissal occurs before day 28, a follow-up interview will be conducted in presence or on the phone to collect the remaining data.
The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods (Kaplan-Meier curves with log-rank test and Cox regression), while secondary outcomes will be evaluated using both survival-based methods and proportional odds model.
The occurrence of adverse events and the causes of withdrawal from the study in the two branches of treatment will be compared using chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care + prone positioning | Experimental | Procedure: prone positioningStandard of care. Prone-positioning cycles as the following: 3-6 hours of prone-positioning twice a day. |
| Standard of care | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- positive PCR for Sars-Cov-2 Rna on any respiratory samples within 7 days from enrollment
- imaging positive for pulmonary involvement or clinical evidence of respiratory involvement ( new onest of hypoxemia with 02 <80mmHg or SpO2 < 94% in air or need for oxygen therapy in oreder to mantaine SpO2 > 93%.
- need of hospitalization
Key exclusion criteria (4 listed)
- start of prone-positioning cycles before being enrolled in the study
- SpO2/FiO2 <200
- need of high-flow oxygen therapy (HFNC) or need of non-invasive ventilation and/or CPAP or indications for intubation and mechanical ventilation
- relative or absolute contraindications for prone positioning (eg facial fractures, advanced pregnancy, mental status alterations, spinal instability...)
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 |
|---|---|---|
| prone positioning3-6 hours of prone-positioning twice a day | Procedure or surgery | Standard of care + prone positioning |
Primary outcome
Accomplishment of the end-points
Time frame: 0-28 days
the occurence of the first of the following end-points: death, start of high flow oxygen therapy, CPAP, meccanichal ventilation, P/F <200
6 secondary outcomes
time of recovery
Time frame: 0-28 days
time of weaning from oxygen
Time frame: 0-28 days
variation of the clinical condition
Time frame: 0-28 days
mortality
Time frame: 0-28 days
number of adverse event
Time frame: 0-28 days
number and duration of prone positioning cycles
Time frame: 0-28 days
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 1 Nov 2022.
Related trials for COVID-19 Pneumonia
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 3
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 3
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
COVID-19 Infection
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.
Paolo Bonfanti principal investigator
asst-monza Ospedale San Gerardo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prone positioning in people with COVID-19 Pneumonia, run by University of Milano Bicocca at 1 site in Italy.
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 4 inclusion and 4 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 1 Nov 2022. 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 Italy. 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?
Accomplishment of the end-points (time frame: 0-28 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 1 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.