NCT04379258

Brief Summary

The recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
868

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2021

Completed
Last Updated

September 28, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

April 22, 2020

Last Update Submit

September 22, 2021

Conditions

COVID-19Critical IllnessEffectivenessOutcome, Fatal

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    rate (%)

    events during the ICU stay, up to 3 months

Secondary Outcomes (9)

  • hospital mortality

    events through study completion during the hospital stay, up to 5 months

  • 28-day mortality

    events through study completion considered from ICU admission up to 28 days

  • effectiveness of treatment

    through study completion considered from ICU admission until ICU discharge, up to 3 months

  • length of ICU stay

    through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 months

  • length of hospital stay

    through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Case definition : Any critically ill patients with a positive respiratory tract sample result (tracheal aspirate or nasopharyngeal exudate) using the PCR9 technique for the SARS-CoV-2 virus and requiring admission to the ICU at trial will be considered a confirmed case of COVID-19 disease of the doctor responsible for the sick.

You may qualify if:

  • patients over 18 years of age who are admitted to the ICU with the confirmed diagnosis of COVID-19.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (6)

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PMID: 32109013BACKGROUND

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PMID: 32171076BACKGROUND

  • Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.

    PMID: 32227758BACKGROUND

  • Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

    PMID: 32250385BACKGROUND

  • Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

    PMID: 32105632RESULT

  • Penuelas O, Del Campo-Albendea L, de Aledo ALG, Anon JM, Rodriguez-Solis C, Mancebo J, Vera P, Ballesteros D, Jimenez J, Maseda E, Figueira JC, Franco N, Algaba A, Aviles JP, Diaz R, Abad B, Canabal A, Abella A, Gordo F, Garcia J, Suarez JG, Cedeno J, Martinez-Palacios B, Manteiga E, Martinez O, Blancas R, Bardi T, Pestana D, Lorente JA, Muriel A, Esteban A, Frutos-Vivar F. Long-term survival of mechanically ventilated patients with severe COVID-19: an observational cohort study. Ann Intensive Care. 2021 Oct 2;11(1):143. doi: 10.1186/s13613-021-00929-y.

    PMID: 34601646DERIVED

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

  • Oscar Peñuelas, P.h.D

    Fundación de Investigación del Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

May 7, 2020

Study Start

February 8, 2021

Primary Completion

February 8, 2021

Study Completion

February 8, 2021

Last Updated

September 28, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months
Access Criteria
Direct request to the Principal Investigator

Locations

ES(1)