ClinicalTrials.gg
Status unknownNCT04316949Updated Apr 7, 2020

Predictors of Respiratory Failure in SARS-Cov-2 Infection

An observational study in SARS-CoV-2 Pneumonia, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by University of Bologna · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
350
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • SARS-CoV-2 Pneumonia
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In context

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
  • Age > 17 years

Exclusion criteria

Exclusion Criteria:

  • Invasive mechanical ventilation within 12 hours from hospital admission
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 14 days

Secondary outcomes

  1. Occurence of bacterial superinfection

    Incidence of bacterial superinfection among ventilated patients with SARS-CoV-2 pneumonia

    Time frame: 14 days

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Study locations

1 of 1 sites recruiting
  • University of Bologna - Department of Medical and Surgical Sciences
    Bologna, 40138, Italy
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Participant from other centers may request to analyze the registry for other purposes upon IRB and study group approval

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Apr 2020, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2020
First posted
Mar 20, 2020
StartActual
Mar 20, 2020
Primary completionEst.
Apr 30, 2020
CompletionEst.
May 31, 2020
Last update
Apr 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04316949
Responsible party
Michele Bartoletti (Assistant Professor, University of Bologna) — Principal investigator
First posted
Mar 20, 2020
Start date
Mar 20, 2020
Primary completion
Apr 30, 2020 (estimated)
Completion
May 31, 2020 (estimated)
Last update
Apr 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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