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Multicenter Study
. 2021 Jul 17;398(10296):223-237.
doi: 10.1016/S0140-6736(21)00799-6.

Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study

Thomas M Drake  1 , Aya M Riad  1 , Cameron J Fairfield  1 , Conor Egan  1 , Stephen R Knight  1 , Riinu Pius  1 , Hayley E Hardwick  2 , Lisa Norman  1 , Catherine A Shaw  1 , Kenneth A McLean  1 , A A Roger Thompson  3 , Antonia Ho  4 , Olivia V Swann  5 , Michael Sullivan  6 , Felipe Soares  3 , Karl A Holden  7 , Laura Merson  8 , Daniel Plotkin  8 , Louise Sigfrid  8 , Thushan I de Silva  3 , Michelle Girvan  9 , Clare Jackson  9 , Clark D Russell  10 , Jake Dunning  11 , Tom Solomon  12 , Gail Carson  8 , Piero Olliaro  8 , Jonathan S Nguyen-Van-Tam  13 , Lance Turtle  2 , Annemarie B Docherty  1 , Peter Jm Openshaw  14 , J Kenneth Baillie  9 , Ewen M Harrison  15 , Malcolm G Semple  16 ; ISARIC4C investigators
Collaborators, Affiliations
Multicenter Study

Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study

Thomas M Drake et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2021 Jul 31;398(10298):390. doi: 10.1016/S0140-6736(21)01690-1. Lancet. 2021. PMID: 34332681 Free PMC article. No abstract available.

Abstract

Background: COVID-19 is a multisystem disease and patients who survive might have in-hospital complications. These complications are likely to have important short-term and long-term consequences for patients, health-care utilisation, health-care system preparedness, and society amidst the ongoing COVID-19 pandemic. Our aim was to characterise the extent and effect of COVID-19 complications, particularly in those who survive, using the International Severe Acute Respiratory and Emerging Infections Consortium WHO Clinical Characterisation Protocol UK.

Methods: We did a prospective, multicentre cohort study in 302 UK health-care facilities. Adult patients aged 19 years or older, with confirmed or highly suspected SARS-CoV-2 infection leading to COVID-19 were included in the study. The primary outcome of this study was the incidence of in-hospital complications, defined as organ-specific diagnoses occurring alone or in addition to any hallmarks of COVID-19 illness. We used multilevel logistic regression and survival models to explore associations between these outcomes and in-hospital complications, age, and pre-existing comorbidities.

Findings: Between Jan 17 and Aug 4, 2020, 80 388 patients were included in the study. Of the patients admitted to hospital for management of COVID-19, 49·7% (36 367 of 73 197) had at least one complication. The mean age of our cohort was 71·1 years (SD 18·7), with 56·0% (41 025 of 73 197) being male and 81·0% (59 289 of 73 197) having at least one comorbidity. Males and those aged older than 60 years were most likely to have a complication (aged ≥60 years: 54·5% [16 579 of 30 416] in males and 48·2% [11 707 of 24 288] in females; aged <60 years: 48·8% [5179 of 10 609] in males and 36·6% [2814 of 7689] in females). Renal (24·3%, 17 752 of 73 197), complex respiratory (18·4%, 13 486 of 73 197), and systemic (16·3%, 11 895 of 73 197) complications were the most frequent. Cardiovascular (12·3%, 8973 of 73 197), neurological (4·3%, 3115 of 73 197), and gastrointestinal or liver (0·8%, 7901 of 73 197) complications were also reported.

Interpretation: Complications and worse functional outcomes in patients admitted to hospital with COVID-19 are high, even in young, previously healthy individuals. Acute complications are associated with reduced ability to self-care at discharge, with neurological complications being associated with the worst functional outcomes. COVID-19 complications are likely to cause a substantial strain on health and social care in the coming years. These data will help in the design and provision of services aimed at the post-hospitalisation care of patients with COVID-19.

Funding: National Institute for Health Research and the UK Medical Research Council.

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Conflict of interest statement

Declaration of interests ABD reports grants from the Department of Health and Social Care (DHSC), during the conduct of the study; and grants from Wellcome Trust, outside the submitted work. PJMO reports institutional fees from consultancies from Janssen, Oxford Immunotech, Nestle, Pfizer, and the European Respiratory Society; grants from the MRC, MRC Global Challenge Research Fund, EU, NIHR Biomedical Research Centre, MRC, GlaxoSmithKline, Wellcome Trust, and NIHR Health Protection Research Unit (HPRU) in Respiratory Infection; and is NIHR senior investigator outside the submitted work. PJMO's role as president of the British Society for Immunology was unpaid but travel and accommodation at some meetings was provided by the Society.JKB reports grants from MRC UK. MGS reports grants from DHSC, NIHR UK, MRC UK, HPRU in Emerging and Zoonotic Infections, and University of Liverpool, during the conduct of the study; and is chair of the Infectious Diseases Science Advisory Board and minority shareholder of Integrum Scientific, Greensboro NC, outside the submitted work. All other authors declare no competing interests.

Figures

Figure 1
Figure 1
Study profile
Figure 2
Figure 2
Outcomes and mortality after complications (A) Differences in complication rates, age, sex, and comorbidity. (B) Kaplan-Meier survival curve stratified by number of complications had. The hazard ratios are: no complications 1 (reference level); one complication 1·50 (95% CI 1·45–1·55, p<0·0001); two complications 1·87 (1·80–1·94, p<0·0001); three complications 2·39 (2·29–2·50, p<0·0001); four complications 2·64 (2·50–2·79, p<0·0001); and five complications 2·81 (2·67–2·95, p< 0·0001). (C) Hazard ratios for effect of organ-specific complications on overall survival, adjusted for age, sex, indices of multiple deprivation quintile, and study centre (appendix pp 14–20). (D) Effect of organ-specific complications on odds of being admitted to critical care (appendix pp 21–27). Error bars represent 95% CIs.
Figure 3
Figure 3
Relationship between age, sex, comorbidities, and adjusted outcomes using generalised additive models (A) Relationships for the outcome of adjusted risk of any complication. (B) Relationships for the outcome of adjusted mortality risk, stratified by presence of complications. Each line represents one bootstrap replicate (ie, one simulated patient). The appendix (pp 39–44) shows models for other organ-specific complications.
Figure 4
Figure 4
Relationship between in-hospital complications and ability to self-care at time of discharge or transfer to other health-care facility (A) Ability to self-care at discharge in patients who had complications by age group and sex. (B) Ability to self-care at discharge by disease severity. (C) Adjusted odds of worse ability to self-care at discharge by organ-specific complications in adults admitted to hospital with severe COVID-19 (appendix pp 27–34). Error bars represent 95% CIs.
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References

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