NCT04388670

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 12, 2020

Last Update Submit

May 12, 2020

Conditions

COVID-19Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 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.

    22nd February - 22nd August 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with COVID-19 admitted in Intensive Care Units.

You may qualify if:

  • Adulthood
  • Informed consent obtained

You may not qualify if:

  • No informed consent obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 39326356DERIVED

  • Scaravilli 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.

    PMID: 35698155DERIVED

  • Zanella 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.

    PMID: 34373952DERIVED

  • Grasselli 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.

    PMID: 33857475DERIVED

  • Langer 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.

    PMID: 33823862DERIVED

MeSH Terms

Conditions

COVID-19Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giacomo Grasselli, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Grasselli, MD

CONTACT

+390255033285giacomo.grasselli@unimi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 14, 2020

Study Start

February 22, 2020

Primary Completion

August 22, 2020

Study Completion

August 31, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Locations

IT(1)