#Outcomes of #COVID19 related #hospitalization among people with #HIV in the #ISARIC #WHO #Clinical Characterization Protocol (#UK): a prospective observational study (Clin Infect Dis., abstract)

[Source: Clinical Infectious Diseases, full page: (LINK). Abstract, edited.]

Outcomes of COVID-19 related hospitalization among people with HIV in the ISARIC WHO Clinical Characterization Protocol (UK): a prospective observational study

Anna Maria Geretti, Alexander J Stockdale, Sophie H Kelly, Muge Cevik, Simon Collins, Laura Waters, Giovanni Villa, Annemarie Docherty, Ewen M Harrison, Lance Turtle, Peter J M Openshaw, J Kenneth Baillie, Caroline A Sabin, Malcolm G Semple

Clinical Infectious Diseases, ciaa1605, https://doi.org/10.1093/cid/ciaa1605

Published: 23 October 2020

Abstract

Background

Evidence is conflicting about how HIV modulates COVID-19. We compared the presentation characteristics and outcomes of adults with and without HIV who were hospitalized with COVID-19 at 207 centers across the United Kingdom and whose data were prospectively captured by the ISARIC WHO CCP study.

Methods

We used Kaplan-Meier methods and Cox regression to describe the association between HIV status and day-28 mortality, after separate adjustment for sex, ethnicity, age, hospital acquisition of COVID-19 (definite hospital acquisition excluded), presentation date, ten individual comorbidities, and disease severity at presentation (as defined by hypoxia or oxygen therapy).

Results

Among 47,592 patients, 122 (0.26%) had confirmed HIV infection and 112/122 (91.8%) had a record of antiretroviral therapy. At presentation, HIV-positive people were younger (median 56 versus 74 years; p<0.001) and had fewer comorbidities, more systemic symptoms and higher lymphocyte counts and C-reactive protein levels. The cumulative day-28 mortality was similar in the HIV-positive vs. HIV-negative groups (26.7% vs. 32.1%; p=0.16), but in those under 60 years of age HIV-positive status was associated with increased mortality (21.3% vs. 9.6%; p<0.001 [log-rank test]). Mortality was higher among people with HIV after adjusting for age (adjusted hazard ratio [aHR] 1.47, 95% confidence interval [CI] 1.01-2.14; p=0.05), and the association persisted after adjusting for the other variables (aHR 1.69; 95% CI 1.15-2.48; p=0.008) and when restricting the analysis to people aged <60 years (aHR 2.87; 95% CI 1.70-4.84; p<0.001).

Conclusions

HIV-positive status was associated with an increased risk of day-28 mortality among patients hospitalized for COVID-19.

COVID-19, SARS-CoV-2, HIV, mortality

Issue Section: Major Article

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© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Keywords: SARS-CoV-2; COVID-19; HIV/AIDS; ISARIC; WHO.

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#ISARIC #COVID19 #Clinical #Data #Report: 4 October 2020 (MedRxIV, abstract)

[Source: MedRxIV, full page: (LINK). Abstract, edited.]

ISARIC COVID-19 Clinical Data Report: 4 October 2020

Mark Pritchard,   Emmanuelle Dankwa,   Matthew Hall,   J Kenneth Baillie,   Gail  Carson,   Annemarie B Docherty,   Christl Donnelly,   Jake Dunning,   Christophe  Fraser,   Hayley Hardwick,   Ewen M Harrison,   Karl Holden,   Christiana  Kartsonaki,   Kalynn Kennon,   James Lee,   Kenneth McLean,   Peter JM Openshaw,    Daniel R Plotkin,   Amanda Rojek,   Clark D Russell,   Malcolm Gracie Semple,   Louise  Sigfrid,   Peter Horby,   Piero L Olliaro,   Laura Merson

DOI: doi: https://doi.org/10.1101/2020.07.17.20155218

This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Abstract

ISARIC (International Severe Acute Respiratory and emerging Infections Consortium) partnerships and outbreak preparedness initiatives enabled the rapid launch of standardised clinical data collection on COVID-19 in Jan 2020. Extensive global uptake of this resource has resulted in a large, standardised collection of comprehensive clinical data from hundreds of sites across dozens of countries. Data are analysed regularly and reported publicly to inform patient care and public health response. This report is a part of a series and includes the results of data analysis on 4 October 2020. We thank all of the data contributors for their ongoing support.

Report highlights include:

ISARIC collaborators recorded symptoms from over 102,000 patients in hospital with COVID-19. Most had fever, cough or shortness of breath. Children and older adults were less likely to display typical symptoms, and over 40% of patients >80 years experienced confusion. The ISARIC international database continues to grow. Data have been entered for 102,959 individuals from 566 sites across 42 countries. The analysis detailed in this report only includes individuals:

  1. for whom data collection commenced on or before 14 September 2020.
    • AND
  2. who have laboratory-confirmed or clinically-diagnosed SARS-COV-2 infection.

For the 88,463 cases who meet eligibility criteria for this report:

  • The median age is 72 years.
  • A total of 18% of patients were admitted at some point during their illness into an intensive care unit.
  • Antibiotic use is high (82.2% of patients received antibiotics – the choice of antibiotic and specific indication have not yet been determined.)
  • Fever, shortness of breath, a non-productive cough and fatigue were the most common symptoms.
  • Altered consciousness/confusion was also relatively frequent (19,619/86,175) and most common in elderly patients.

Overall, elderly patients are less likely to present with URTI symptoms. To access previous versions of ISARIC COVID-19 Clinical Data Report please use the link below: https://isaric.tghn.org/COVID-19-Data-Management-Hosting/evidence-reports/

Competing Interest Statement: The authors have declared no competing interest.

Clinical Protocols https://isaric.net/ccp/ | https://isaric4c.net/

Funding Statement: This work is supported by grants fincluding: the National Institute for Health Research (NIHR; award CO-CIN-01), the Medical Research Council (MRC; grant MC_PC_19059), the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (PHE), in collaboration with Liverpool School of Tropical Medicine and the University of Oxford (NIHR award 200907), Wellcome Trust and Department for International Development (DID; 215091/Z/18/Z), and the Bill and Melinda Gates Foundation (OPP1209135), and Liverpool Experimental Cancer Medicine Centre for providing infrastructure support for this research (grant reference C18616/A25153). Contents of the publication are those of the authors and not necessarily reflect those of the funders. Additional funding support can be viewed at https://isaric.tghn.org/covid-19-data-management-hosting-contributors/.

Author Declarations:

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics Committee approval was given by the WHO Ethics Review Committee (RPC571 and RPC572, 25 April 2013). Institutional approval was additionally obtained by participating sites including the South Central – Oxford C Research Ethics Committee in England (Ref 13/SC/0149), the Scotland A Research Ethics Committee (Ref 20/SS/0028) for the UK, which represents the majority of the data. Other institutional and national approvals are in place as per local requirements.

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv

Keywords: SARS-CoV-2; COVID-19.

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#COVID19 #Report: 03 September 2020 – Containing data extracted 20 August 2020 (ISARIC, summary)

[Source: International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), full page: (LINK). Summary, edited.]

ISARIC (International Severe Acute Respiratory and Emerging Infections Consortium) – A global federation of clinical research networks, providing a proficient, coordinated, and agile research response to outbreak-prone infectious diseases

COVID-19 Report: 03 September 2020 – Containing data extracted 20 August 2020

Summary

The results in this report have been produced using data from the ISARIC COVID-19  database. For information, or to contribute to the collaboration, please contact  ncov@isaric.org.

We thank all of the data contributors for collecting standardised data during these  extraordinary times.

We plan to issue this report of aggregate data regularly for the duration of the SARS- CoV-2/COVID-19 pandemic.

Please note the following caveats. This is a dynamic report which captures new  variables and information as our understanding of COVID-19 evolves. Please observe  the N of each result to note newly added variables with fewer data points.  Information is incomplete for the many patients who are still being treated.

Furthermore, it is likely that that we received more cases of severely ill individuals  than those with relatively less severe illness; outcomes from these data, such as the  proportion dying, must therefore not be used to infer outcomes for the entire  population of people who might become infected. Some patients may be participants  in clinical trials of experimental interventions. Many of the included cases are from  the United Kingdom.

Additional caveats are provided in the in the ‘Caveats’ section below.

Up to the date of this report, data have been entered for 96074 individuals from 562  sites across 42 countries.

The analysis detailed in this report only includes individuals:

  1. for whom data collection commenced on or before 06 August 2020. (We have  applied a 14-day rule to focus analysis on individuals who are more likely to  have a recorded outcome. By excluding patients enrolled during the last 14  days, we aim to reduce the number of incomplete data records and thus improve the generalisability of the results and the accuracy of the outcomes.  However, this limits our focus to a restricted cohort despite the much larger  volumes of data held in the database.)
    • AND
  2. who have laboratory-confirmed or clinically-diagnosed SARS-COV-2 infection.  The cohort satisfying the above criteria has 81705 cases (95.82% are laboratory- confirmed for SARS-COV-2 infection).

The flow chart in Figure 1 gives an overview of the cohort and outcomes as of 20  August 2020.

Demographics and presenting features

Of these 81705 cases, 46516 are males and 35033 are females – sex is unreported for  156 cases. The minimum and maximum observed ages were 0 and 106 years  respectively. The median age is 72 years. The observed mean number of days from  (first) symptom onset to hospital admission was 7.8, with a standard deviation (SD)  of 6.2 days and a median of 4 days. For all time-to-event variables, values greater  than 120 days were treated as outliers and were excluded prior to any analysis.

The observed mean duration for the number of days from hospital admission to  outcome (death or discharge) was 12.6, with SD 13 days and a median of 9 days.  These estimates are based on all cases which have complete records on length of  hospital stay (N = 77733).

The observed symptoms on admission partly represent case definitions and policies  for hospital admission, which may change as time passes. The five most common  symptoms at admission were history of fever, shortness of breath, cough,  fatigue/malaise, and confusion. Frequencies of symptom prevalence vary with age.
25621/81862 (31.3%) patients presented with oxygen saturations <94%.

Outcomes

Outcomes have been recorded for 70225 patients, consisting of 47367 recoveries and  22858 deaths. Follow-up is ongoing for 2092 patients. Outcome records are  unavailable for 9388 patients.

ICU/HDU:

A total of 13977 (17%) patients were admitted at some point of their illness into an  intensive care unit (ICU) or high dependency unit (HDU). Of these, 4770 died, 586 are  still in hospital and 6348 have recovered and been discharged.

The observed mean and median durations (in days) from hospital admission to  ICU/HDU admission were 2.9 and 1 respectively (SD: 6.8) – estimated from records on  cases with complete date records on hospital admission and ICU/HDU entry (N = 13275). The duration of stay in ICU/HDU had a mean of 13.2 days and a median of 8.5  (SD: 13.4 days) – estimated on only those cases with complete records for ICU/HDU  duration or ICU/HDU start/end dates (N = 12088). Of these 13977 patients who were  admitted into ICU/HDU, 4770 died, 586 are still in hospital and 6348 have recovered  and been discharged. Outcome records are unavailable for 2273 cases.

Approximately 40% of patients with complete records on ICU admission dates were  admitted to ICU within the first day of hospital admission. The distribution of the  number of days from admission to ICU admission is shown in Figure 11.

Treatment

Antibiotics were received by 61796/74836 (82.6%) patients, and 7560/73902 (10.2%)  received antivirals. These treatment categories are not mutually exclusive since  some patients received multiple treatments. (The denominators differ due to data  completeness.) 53920/80358 (67.1%) patients received some degree of oxygen supplementation: of these, 12300/53920 (22.8%) received NIV and 8803/53920 (16.3%)  IMV. Of the patients admitted into ICU/HDU, 12091/13010 (92.9%) received  antibiotics and 9398/18796 (50%) antivirals. 13028/13903 (93.7%) received some  degree of oxygen supplementation, of which, 6980/13028 (53.6%) received NIV and  8272/13028 (63.5%) IMV. A total of 12300 patients received non-invasive mechanical  ventilation (NIV). The mean and median durations from admission to receiving NIV  were 4.2 days and 2 days respectively (SD: 8.7 days) – estimated from records on  cases with complete records on dates of hospital admission and NIV onset (N = 9252).  The mean and median durations for NIV were 2.4 days and 0 days  respectively (SD: 5.4 days) – estimated based on only those cases which have  complete NIV duration records (N = 5143). A total of 8803 patients received invasive  mechanical ventilation (IMV). The mean and median durations from admission to  receiving IMV were 3.7 days and 2 days respectively (SD: 7.9 days) – estimated from  records on cases with complete records on dates of hospital admission and IMV  onset (N = 7771). The mean, median and SD for the duration of IMV – estimated  based on all 6624 cases with complete records on IMV stays – were 14.6 days, 11 days  and 12.2 days respectively. Corticosteroids were administered to 12683 / 73354  (17.3%) patients. This includes 2851 / 7663 (37.2%) of those who received IMV, 7491 /  42387 (17.7%) of those who had oxygen therapy but not IMV, and 2332 / 23217  (10.0%) of those who had no oxygen therapy. On 16 June, results for dexamethasone  were released for the RECOVERY randomized controlled trial (RECOVERY, 2020;  RECOVERY Collaborative Group, 2020). This trial found that dexamethasone reduced  deaths for patients receiving IMV and oxygen therapy, but not among patients not  receiving respiratory support. Of patients admitted since 16 June, corticosteroids were received by 127 / 183 (69.4%) of those who received IMV, 464 / 1144 (40.6%) of  those who had oxygen therapy but not IMV, and 155 / 1316 (11.8%) of those who had no oxygen therapy.

(…)

Keywords: SARS-CoV-2; COVID-19.

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