SARS-CoV-2 PneumoniaNCT04316949
Predictors of Respiratory Failure in SARS-Cov-2 Infection
An observational study of SARS-CoV-2 Pneumonia, run by University of Bologna at 1 site in Italy.
Trial summary
The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- SARS-CoV-2 Pneumonia
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2020to 31 May 2020
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
Who may be able to join
- Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
- Age > 17 years
Who cannot join
- Invasive mechanical ventilation within 12 hours from hospital admission
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Bologna - Department of Medical and Surgical Sciences
Bologna, 40138
Pierluigi Viale, MD, + 39 051 214 3018, pierluigi.viale@unibo.it
About this study
Official title: Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection
The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia.
A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy
Read the detailed description
The study will compared patients with and without respiratory failure in order to find risk factors for need for ICU admission. A simple score based on risk factors will be created from a multicenter Italian cohort and validated in a multicenter international cohort.
- Conditions
- SARS-CoV-2 Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Derivation cohort | Derivation cohort: Italian retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from February 20 to March 19 2020. . | |
| Validation cohort | Validation cohort: European and non-European retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from March 19 to April 18 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory failure
Composite of ICU admission or SpO2<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate >30 bpm, respiratory distress
Measured: 14 days
Secondary outcomes (1)
Occurence of bacterial superinfection
Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start20 Mar 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Bartoletti, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316949
- Sponsor's protocol ID
- PREDI-CO
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant from other centers may request to analyze the registry for other purposes upon IRB and study group approval
Publications
Bartoletti M, Giannella M, Scudeller L, Tedeschi S, Rinaldi M, Bussini L, Fornaro G, Pascale R, Pancaldi L, Pasquini Z, Trapani F, Badia L, Campoli C, Tadolini M, Attard L, Puoti M, Merli M, Mussini C, Menozzi M, Meschiari M, Codeluppi M, Barchiesi F, Cristini F, Saracino A, Licci A, Rapuano S, Tonetti T, Gaibani P, Ranieri VM, Viale P; PREDICO study group. Development and validation of a prediction model for severe respiratory failure in hospitalized patients with SARS-CoV-2 infection: a multicentre cohort study (PREDI-CO study). Clin Microbiol Infect. 2020 Nov;26(11):1545-1553. doi: 10.1016/j.cmi.2020.08.003. Epub 2020 Aug 8.
PubMed 32781244
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection
- ClinicalTrials.gov ID
- NCT04316949
- Acronym / sponsor ID
- PREDI-CO
- Conditions
- SARS-CoV-2 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 20 Mar 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 emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia.
A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy
Detailed description
The study will compared patients with and without respiratory failure in order to find risk factors for need for ICU admission. A simple score based on risk factors will be created from a multicenter Italian cohort and validated in a multicenter international cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | –Derivation cohort: Italian retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from February 20 to March 19 2020. . |
| Validation cohort | – | –Validation cohort: European and non-European retrospective cohort of all consecutive hospitalized patients with SARS-CoV-2 pneumonia in the participating centers, from March 19 to April 18 2020. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
Key inclusion criteria (2 listed)
- Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
- Age > 17 years
Key exclusion criteria (1 listed)
- Invasive mechanical ventilation within 12 hours from hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory failure
Time frame: 14 days
Composite of ICU admission or SpO2<92% with 100% FiO2 of oxygen treatment (reservoir mask or CPAP or NIV), respiratory rate >30 bpm, respiratory distress
1 secondary outcome
Occurence of bacterial superinfection
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 32781244Bartoletti M, Giannella M, Scudeller L, Tedeschi S, Rinaldi M, Bussini L, Fornaro G, Pascale R, Pancaldi L, Pasquini Z, Trapani F, Badia L, Campoli C, Tadolini M, Attard L, Puoti M, Merli M, Mussini C, Menozzi M, Meschiari M, Codeluppi M, Barchiesi F, Cristini F, Saracino A, Licci A, Rapuano S, Tonetti T, Gaibani P, Ranieri VM, Viale P; PREDICO study group. Development and validation of a prediction model for severe respiratory failure in hospitalized patients with SARS-CoV-2 infection: a multicentre cohort study (PREDI-CO study). Clin Microbiol Infect. 2020 Nov;26(11):1545-1553. doi: 10.1016/j.cmi.2020.08.003. Epub 2020 Aug 8.
- Individual participant dataSharing planned: Undecided. Participant from other centers may request to analyze the registry for other purposes upon IRB and study group approval
Related trials for SARS-CoV-2 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
University of Bologna - Department of Medical and Surgical Sciences
Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Pneumonia, run by University of Bologna 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory failure (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316949, which also lists 1 linked publication.
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 7 Apr 2020.