Clinical Characteristics and Outcomes of 187 Critically Ill Patients With Coronavirus Disease 2019 (COVID-19)

NCT04454372 | Completed

• 1 other identifier: covid-19 ICU
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

Conditions

COVID-19

Keywords

COVID-19; critically ill patients; outcomes; treatment

Outcome Measures

Primary Outcomes (1)

• Outcome 30 days after ICU admission

  A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized

  30 days after admission

Interventions

demographic and clinical data obtained from hospital's electronic medical record. OTHER

This retrospective observational study. . Demographic and severity data will include age, sex, SAPS 3 and SOFA scores at admission, nutritional risk determined by NRS-2002 and commodities. Clinical and laboratory data on arrival at the ICU including PaO2 / FIO2, blood count and PCR D-dimer, ferritin, fibrinogen, DHL. Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position and ECMO and vasoactive drugs. The main complications, acute kidney injury requiring renal replacement therapy, secondary infectious complications will be documented as well as the outcomes.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All critically ill patients admitted to the 35 beds ICU dedicated to COVID-19 in the period of March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19. Patients that could be managed without invasive mechanical ventilation and that did not require other high level life support were managed in one of the semi intensive units (16 and 21 beds).

You may qualify if:

• All patients admitted to the 35 beds ICU between March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19 (RT-PCR).

You may not qualify if:

• Patients admitted to the ICU in which the RT-PCR was negative, and patients that did not require high level life support (RRT, Prone position, ECMO, hemodymnamic monitoring and support).

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-000, Brazil

Location

Related Publications (8)

• Yang P, Tekwani S, Martin GS. In COVID-19, adding lopinavir-ritonavir to usual care did not shorten time to clinical improvement. Ann Intern Med. 2020 Jun 16;172(12):JC63. doi: 10.7326/ACPJ202006160-063.

  PMID: 32539520 BACKGROUND

• Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.

  PMID: 32275812 BACKGROUND

• Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.

  PMID: 32222812 BACKGROUND

• 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: 32109013 RESULT

• Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.

  PMID: 32320003 RESULT

• Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020 May;55(5):105954. doi: 10.1016/j.ijantimicag.2020.105954. Epub 2020 Mar 29.

  PMID: 32234467 RESULT

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 RESULT

• Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

  PMID: 32167524 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Demography

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• JOSE AZEVEDO, MD

  Hospital Sao Domingos

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: July 15, 2020
• Primary Completion: September 20, 2020
• Study Completion: November 30, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)