COVID-192019nCoV_ICUNCT04388670
Epidemiological and Clinical Characteristics of Critically Ill Patients With COVID-19
An observational study of COVID-19 and Critical Illness, run by Policlinico Hospital at 1 site in Italy.
Trial summary
Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Critical Illness
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2020to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with COVID-19 admitted in Intensive Care Units.
Who may be able to join
- Adulthood
- Informed consent obtained
Who cannot join
- No informed consent obtained
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, 20100
Giacomo Grasselli, MD, +390255033285, giacomo.grasselli@unimi.it
About this study
Official title: Epidemiological and Clinical Characteristics of Patients With COVID-19 Admitted in Italian Intensive Care Units: a Multicentric Retrospective-prospective Cohort Study.
Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.
- Conditions
- COVID-19, Critical Illness
- Medical subject headings
- COVID-19, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number and characteristics of patients with COVID-19 in ICU
Number and characteristics of patients with COVID-19 admitted in Intensive Care Units every week.
Measured: 22nd February - 22nd August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start22 Feb 2020
- Primary completion22 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Giacomo Grasselli, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388670
- Sponsor's protocol ID
- PoliclinicoH
- Acronym
- 2019nCoV_ICU
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Protti A, Madotto F, Florio G, Bove T, Carlesso E, Casella G, Dalla Corte F, Foti G, Giudici R, Langer T, Montalto C, Rezoagli E, Santini A, Terragni P, Zanella A, Grasselli G, Cecconi M. A tidal volume of 7 mL/kg PBW or higher may be safe for COVID-19 patients. J Crit Care. 2025 Feb;85:154921. doi: 10.1016/j.jcrc.2024.154921. Epub 2024 Sep 25.
PubMed 39326356Scaravilli V, Guzzardella A, Madotto F, Beltrama V, Muscatello A, Bellani G, Monti G, Greco M, Pesenti A, Bandera A, Grasselli G. Impact of dexamethasone on the incidence of ventilator-associated pneumonia in mechanically ventilated COVID-19 patients: a propensity-matched cohort study. Crit Care. 2022 Jun 13;26(1):176. doi: 10.1186/s13054-022-04049-2.
PubMed 35698155Zanella A, Florio G, Antonelli M, Bellani G, Berselli A, Bove T, Cabrini L, Carlesso E, Castelli GP, Cecconi M, Citerio G, Coloretti I, Corti D, Dalla Corte F, De Robertis E, Foti G, Fumagalli R, Girardis M, Giudici R, Guiotto L, Langer T, Mirabella L, Pasero D, Protti A, Ranieri MV, Rona R, Scudeller L, Severgnini P, Spadaro S, Stocchetti N, Vigano M, Pesenti A, Grasselli G; COVID-19 Italian ICU Network. Time course of risk factors associated with mortality of 1260 critically ill patients with COVID-19 admitted to 24 Italian intensive care units. Intensive Care Med. 2021 Sep;47(9):995-1008. doi: 10.1007/s00134-021-06495-y. Epub 2021 Aug 9.
PubMed 34373952Grasselli G, Scaravilli V, Mangioni D, Scudeller L, Alagna L, Bartoletti M, Bellani G, Biagioni E, Bonfanti P, Bottino N, Coloretti I, Cutuli SL, De Pascale G, Ferlicca D, Fior G, Forastieri A, Franzetti M, Greco M, Guzzardella A, Linguadoca S, Meschiari M, Messina A, Monti G, Morelli P, Muscatello A, Redaelli S, Stefanini F, Tonetti T, Antonelli M, Cecconi M, Foti G, Fumagalli R, Girardis M, Ranieri M, Viale P, Raviglione M, Pesenti A, Gori A, Bandera A. Hospital-Acquired Infections in Critically Ill Patients With COVID-19. Chest. 2021 Aug;160(2):454-465. doi: 10.1016/j.chest.2021.04.002. Epub 2021 Apr 20.
PubMed 33857475Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2.
PubMed 33823862
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological and Clinical Characteristics of Patients With COVID-19 Admitted in Italian Intensive Care Units: a Multicentric Retrospective-prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04388670
- Acronym / sponsor ID
- 2019nCoV_ICU / PoliclinicoH
- Conditions
- COVID-19, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 22 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 14 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.
Objective of this observational multicentric retrospective-prospective study is to describe the number and the characteristics of patients with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-CoV2 positivity admitted to Intensive Care Units during the first 6 months of epidemic.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with COVID-19 admitted in Intensive Care Units.
Key inclusion criteria (2 listed)
- Adulthood
- Informed consent obtained
Key exclusion criteria (1 listed)
- No informed consent obtained
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
Overall number and characteristics of patients with COVID-19 in ICU
Time frame: 22nd February - 22nd August 2020
Number and characteristics of patients with COVID-19 admitted in Intensive Care Units every week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 39326356Protti A, Madotto F, Florio G, Bove T, Carlesso E, Casella G, Dalla Corte F, Foti G, Giudici R, Langer T, Montalto C, Rezoagli E, Santini A, Terragni P, Zanella A, Grasselli G, Cecconi M. A tidal volume of 7 mL/kg PBW or higher may be safe for COVID-19 patients. J Crit Care. 2025 Feb;85:154921. doi: 10.1016/j.jcrc.2024.154921. Epub 2024 Sep 25.
- Derived from this study: PubMed 35698155Scaravilli V, Guzzardella A, Madotto F, Beltrama V, Muscatello A, Bellani G, Monti G, Greco M, Pesenti A, Bandera A, Grasselli G. Impact of dexamethasone on the incidence of ventilator-associated pneumonia in mechanically ventilated COVID-19 patients: a propensity-matched cohort study. Crit Care. 2022 Jun 13;26(1):176. doi: 10.1186/s13054-022-04049-2.
- Derived from this study: PubMed 34373952Zanella A, Florio G, Antonelli M, Bellani G, Berselli A, Bove T, Cabrini L, Carlesso E, Castelli GP, Cecconi M, Citerio G, Coloretti I, Corti D, Dalla Corte F, De Robertis E, Foti G, Fumagalli R, Girardis M, Giudici R, Guiotto L, Langer T, Mirabella L, Pasero D, Protti A, Ranieri MV, Rona R, Scudeller L, Severgnini P, Spadaro S, Stocchetti N, Vigano M, Pesenti A, Grasselli G; COVID-19 Italian ICU Network. Time course of risk factors associated with mortality of 1260 critically ill patients with COVID-19 admitted to 24 Italian intensive care units. Intensive Care Med. 2021 Sep;47(9):995-1008. doi: 10.1007/s00134-021-06495-y. Epub 2021 Aug 9.
- Derived from this study: PubMed 33857475Grasselli G, Scaravilli V, Mangioni D, Scudeller L, Alagna L, Bartoletti M, Bellani G, Biagioni E, Bonfanti P, Bottino N, Coloretti I, Cutuli SL, De Pascale G, Ferlicca D, Fior G, Forastieri A, Franzetti M, Greco M, Guzzardella A, Linguadoca S, Meschiari M, Messina A, Monti G, Morelli P, Muscatello A, Redaelli S, Stefanini F, Tonetti T, Antonelli M, Cecconi M, Foti G, Fumagalli R, Girardis M, Ranieri M, Viale P, Raviglione M, Pesenti A, Gori A, Bandera A. Hospital-Acquired Infections in Critically Ill Patients With COVID-19. Chest. 2021 Aug;160(2):454-465. doi: 10.1016/j.chest.2021.04.002. Epub 2021 Apr 20.
- Derived from this study: PubMed 33823862Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2.
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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.
Giacomo Grasselli, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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 COVID-19 and Critical Illness, run by Policlinico Hospital 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 14 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 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?
Contact Giacomo Grasselli, MD (+390255033285, giacomo.grasselli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall number and characteristics of patients with COVID-19 in ICU (time frame: 22nd February - 22nd August 2020). 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 NCT04388670, which also lists 5 linked publications.
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 14 May 2020.