Brazil Clinical Data Platform Slides 03_08_22.pdf

WHO Global Clinical Platform for COVID-19
Silvia Bertagnolio, MD
Unit head, Antimicrobial Resistance Division
WHO, Geneva
bertagnolios@who.int
August 2022 1

• WHO Global Clinical Platform initiative launched in May 2020.
• Member States, heath care facilities and research networks were
invited to share patient-level anonymized clinical data of people
hospitalized with confirmed or suspected COVID19 using
standardized data collection tools
https://www.who.int/teams/health-care-readiness-clinical-unit/covid-19

Objectives
1. Characterize regional variations and temporal trends in
clinical phenotypes, clinical care, therapeutics,
outcomes, reinfections, variants, vaccination
2. Derive risk factors associated with mortality, severity,
and ICU admission globally and by region
3. Characterize clinical phenotypes, clinical care and
therapeutics, interventions, risk factors in
subpopulations (i.e. children, pregnant women, people
living with HIV, TB, etc)
4. Describe mid- and long- term sequelae of patients
discharged from hospitals or managed at home

Clinical case report forms
June 2022
4

CORE Case Report Form (CRFs): 3 modules
June 2022
5
Eligibility:
Which patients
should complete the
Core CRF?
All individuals hospitalised with
confirmed COVID-19
Children and adults
Pregnant women

Admission Module
Information
collected on the
calendar day of
admission
• INCLUSION CRITERIA
• DEMOGRAPHICS
• VACCINATION
• VITAL SIGNS
• COMORBIDITIES
• REINFECTION
• SIGNS AND SYMPTOMS
• MEDICATIONS
• SUPPORTIVE CARE
• LAB TEST RESULTS
• Clinical suspicion OR Laboratory
confirmation of COVID-19 (antigen
test or molecular test)
• Age or DoB, sex, race, health worker,
pregnancy status
• Type, date and number of doses of
vaccine received
• Vital signs (BP, RR, Temp, HR, SaO2),
Height, Weight, BMI
• Chronic conditions (HTN, DM, CKD,
TB, cancer, liver, neuro diseases etc)
• Date of prev. infection, admission
status
• Clinical features: signs and symptoms
(cough, fever, etc)
• Medications (specific antibodies,
steroids, anticoagulants, antibiotics,
antiviral, antifungals, etc)
• oxygen/ventilation, ECMO,
transfusion, pressor support
• Blood counts, electrolytes, liver and
kidney function, inflammatory
markers

ICU module
Information
collected on ICU
admission or ICU
transfer
• DATE OF ADMISSION
AND VITAL SIGNS
• MEDICATIONS
• SUPPORTIVE CARE
• LAB TEST RESULTS
• Vital signs (BP, RR, Temp,
HR, SaO2), Height, Weight,
BMI
• Medications (specific
antibodies, steroids,
anticoagulants, antibiotics,
antiviral, antifungals, etc)
transfusion, pressor
support
• Blood counts, electrolytes,
liver and kidney function,
inflammatory markers

DISCHARGE
Module
Information
collected on the
day of outcome
• DIAGNOSTIC
RESULTS INCLUDING
COVID VARIANTS
• COMPLICATIONS
• INFECTIONS
• MEDICATIONS
INCLUDING
ANTIBIOTICS
• SUPPORTIVE CARE
RECEIVED
• CO-DIAGNOSES
• CLINICAL OUTCOME
• COVID Variants including
delta/omicron, type of test
used, HIV, Influenza, different
bacteria (e.g MRSA), type and
number of cultures
• Shock, cardiac arrest, DVT,
Pulmonary embolism, ARDS.
• Respiratory, skin, GI, urinary,
bone and joint infections
• Medications (specific
antibodies, steroids,
anticoagulants, antiviral,
antifungals, etc), name of
antibiotics, duration, type of
therapy
transfusion, pressor support
• Discharged alive, death,
transfer to another hospital,
transfer to palliative care

3 simple steps to contribute anonymized clinical data to the Global COVID-
19 Platform
• Register on the REDCAP Platform
• Agree on the Terms of Use
• Receive log-in credentials to access
Terms of Use
Email us: COVID_ClinPlatform@who.int;
How to contribute data

WHO COVID-19 Clinical Platform
Data curation,
aggregation,
analysis,
interpretation
De-identified patient
clinical data from
different settings and
subpopulations
Inform WHO
Guidelines on
COVID-19 clinical
management and
public heath
response
Rapid analysis
WHO GLOBAL, REGIONAL
and COUNTRY REPORTS on
COVID-19 clinical
characterization
Rapid Response
(1) Summarize demographic and clinical features and
intervention globally, in regions and subgroups;
(2) Characterize the variability in the clinical features;
(3) Explore the risk factors associated with mortality
and ICU admission
Inform national
strategies to
respond to COVID19
Inform modelling
work
Inform vaccination
strategies
WHO Global Clinical Platform

629 729 hospitalized cases from 50 countries
(June, 2022)
https://www.who.int/teams/health-care-readiness/covid-19/data-platform
629 729 patients
AFRO 77.1%
AMRO 12.8%
EMRO 0.4%
EURO 9.2%
SEARO 0.4%
WPRO 0.1%
SUBPOPULATION N. of
Cases
PREGNANT 1 625
CHILDREN <19 yrs 30 964
HIV 28 791

Report on HIV-COVID-19:
clinical characteristics and
prognostic factors
Country reports on COVID-19
clinical characterization and
management
Publication: 18th of July
• Jordan
• Brazil
• Nigeria
• Zimbabwe
• Ghana
• Cameroon
Reports in preparation:
• Guinea
• Burkina Faso
• South Africa
• India
• Dominican Republic
• Colombia
Statistical Analysis Plans Dashboard
• Online interactive tool for
the visualization of
Platform data
• Accessible to the pubic
Regional reports on
COVID-19 clinical
characterization and
management
Subpopulations: other
reports in the pipeline:
• Children and
adolescents
• Pregnancy
Co-infections and AMR
WHO Global Clinical Platform - Outputs
SARS-CoV-2 variants and
severity
Severity classification

June 2022
13
WHO Global Clinical Platform – Dashboard

June 2022
14
WHO Global Clinical Platform – Country Reports
Country reports on COVID-19
clinical characterization and
management
• Jordan
• Brazil
• Nigeria
• Zimbabwe
• Ghana
• Cameroon
Reports in preparation:
• Guinea
• Burkina Faso
• South Africa
• India
• Dominican Republic
• Colombia
12
3.2. Signs and symptoms at hospital admission
The most prevalent sign or symptom reported in absolute numbers was cough (265 cases). Figure
3.1 shows the frequency of signs and symptoms at admission. Figure 3.2 shows the top fiv
e s
i g
ns a
nd
symptoms reported at admission and their dif ferent combinations. Figure 3.3 shows the severity of
COVID-19 illness at hospital admission among patients reporting clinical signs and symptoms.
Figure 3.1 Proportion of COVID-19 hospitalized cases presenting with clinical signs and symptoms at
hospital admission
Figure 2.3 Number of COVID-19 hospitalized cases by severity of illness at hospital admission, by sex
and age group
Total number of hospitalized cases
Age
group
% of cases with symptoms
Signs
and
symptoms
at
hospital
admission

• 197479 patients reporting HIV status
• 16955 (8·6%) people living with HIV
• 96.0% from Africa; 62·9% female
• 38·3% were admitted to hospital with severe
illness
• 24·3% died in hospital
• 91·5% on ART
• PLHIV had 15% increased odds of
severe COVID-19 presentation
(aOR 1·15, 95% CI 1·10–1·20)
• 38% more likely to die in hospital
(aHR 1·38, 1·34–1·41)
Lancet HIV, May 2022

WHO Global Clinical Platform for COVID-
19
Omicron Variants and
severity

WHO Global Clinical Platform for COVID-
19
Planned analysis:
COVID-19 in the pediatric population
• Clinical characterization, severity, disease progression, CFRs from COVID-19 across
countries, regions and settings
• Risk factors for severity and mortality
• Monir use of therapeutics and care received
SAP developed – WG with ISARIC
Preliminary analysis to inform PADO for COVID-19

• Studying why some LMIC countries
apparently have higher pediatric
CFRs from COVID-19
• Studying the impact of the COVID-19
vaccine on vulnerable populations in
LMIC context

June 2022
21
AMR and COVID-19

June 2022
• AMR is a leading cause of death around the world, with the highest burdens in low-
resource settings
• In high income countries (HIC), AMR is a serious challenge. In the US, 2.8 million
antibiotic-resistant infections are reported each year, with more than 35 000 deaths
(CDC, 2019).
• Understanding AMR in LMIC is limited: AMR data are unavailable for 42.6% of countries
in Africa (Tadesse et al., 2017).
AMR
Need to expand microbiology laboratory capacity and data collection systems

June 2022
(2019)
• 4.95 million deaths associated with bacterial AMR
• 1.27 million deaths attributable to bacterial AMR
All-age death rate attributable to resistance:
• highest in western sub- Saharan Africa (27.3
deaths per 100 000)
• lowest in Australasia (6.5 deaths per 100 000).
Lower respiratory infections accounted for more
than 1.5 million deaths associated with resistance in
2019, making it the most burdensome infectious
syndrome.

AMR in the Era of COVID-19
Will AMR Decrease?
• Physical distancing
• Hand hygiene
• Reduced influenza rates
• Shifts in healthcare
utilization
• Travel restrictions
Will AMR Increase?
• Concern for co-infection
increases antibiotic prescribing
in patients with COVID-19
• Difficulty differentiating
bacterial from viral etiology
• MDRO screening halted in
some facilities
van Duin D, Barlow G, Nathwani D. The impact of the COVID-19 pandemic on antimicrobial resistance: a debate. JAC-Antimicrobial Resistance. 2020 Sep;2(3):dlaa053
Clancy CJ, Buehrle DJ, Nguyen MH. PRO: The COVID-19 pandemic will result in increased antimicrobial resistance rates. JAC-Antimicrobial Resistance. 2020 Sep;2(3):dlaa049.
Collignon P, Beggs JJ. CON: COVID-19 will not result in increased antimicrobial resistance prevalence. JAC-Antimicrobial Resistance. 2020 Sep;2(3):dlaa051.

Infections in COVID-19 Patients
Reactivation of Latent
Infections (i.e., patients
with COVID-19 receiving
immunomodulatory
therapy)
e.g., chronic hepatitis B, latent
tuberculosis, HSV, VZV,
strongyloidiasis
Nosocomial Infections
e.g., hospital-acquired
bacterial pneumonia, line-
related bacteremia, catheter-
associaed urinary tract
infections, C.difficile
Opportunistic
Infections
e.g., invasive fungal
infections (aspergillosis,
mucormycosis)
Co-infection at
Presentation with
COVID-19
e.g., concomitant viral,
community-acquired
bacterial pneumonia
Secondary Infections

June 2022
Review of national treatment guidelines for COVID-19 in 10 African
countries
The WHO recommended that antibiotic
therapy or prophylaxis should not be used
in patients with mild/moderate COVID-19
unless it is justifiable
Some countries still recommended the use of
antibiotics in the management of mild COVID-19.
Most antibiotics recommended across the African
countries were from the “watch” and “reserve”
categories of WHO AWaRe classification

Characterization Report
• Overall Abx use in over 70% of pts
• Ab were administered to most of the mild/moderate patients in all WHO Regions,
ranging from 97% in PAHO to 26% in EMRO (data from 38 countries)
• More granular information on the specific Ab prescribed, the use of empiric vs
targeted Ab therapy, and incidence of hospital acquired infections, including from
resistant pathogens, will be collected to assess the AMR implications among
individuals hospitalized with COVID-19.
Global COVID-19 Clinical Platform – Antibiotics
June 2022
• 32

AMR among patients hospitalized with COVID-19

Global COVID-19 Clinical Platform – Antibiotic
Focus

June 2022
WHO Global COVID-19 Clinical Platform
4%
61%
12%
23%
Was a
culture to
identify
bacteria
performed?
Yes
No
Unknown
Missing
75%
22%
2%
1%
Antibiotics therapy?
Empiric therapy
Targeted therapy
Unknown
Missing
75% of pts receiving Abx had empiric antibiotic 61% of pts received Abx without a culture
taken before Abx administration
4
10
14
5
1
2
4
Isolated
Pseudomonas
Acinetobacter baumanii
Enterobacteriaceae
Staphylococcus aureus
Enterococcus
Streptococcus pneumoniae
Multi-drug resistant Tuberculosis
The isolated pathogens were consistent
with what reported in the literature
FEB 2022

Role of Antibiotics in COVID-19
Recommendation based on
COVID-19 Severity
Guideline Mild Moderate Severe Statement
World Health Organization 2021 “We recommend for patients with suspected or confirmed severe COVID-19, the use of empiric
antimicrobials to treat all likely pathogens, based on clinical judgment, patient host factors and local
epidemiology, and this should be done as soon as possible”
Surviving Sepsis Campaign
2021 - - - No recommendation
National Institute for Health and Care
Excellence (NICE) 2020
“If there is confidence that the clinical features are typical for COVID-19, it is reasonable not to start
empirical antibiotics”
Infectious Diseases Society of America
2020 - - - No definitive recommendation
National Institutes of Health (NIH) 2021
- - - “insufficient evidence for the Panel to recommend either for or against empiric broad-spectrum
antimicrobial therapy”
Dutch Working Party on Antibiotics 2020 “We generally suggest restrictive use of antibacterial drugs in patients with proven or a high likelihood of
COVID-19. This especially applies for patients who are mildly to moderately ill”
Ontario Clinical Practice Guidelines 2022 Bacterial co-infection is uncommon in COVID-19 pneumonia at presentation. Do not add empiric antibiotics
for bacterial pneumonia unless bacterial infection is strongly suspected.

AMR and COVID19
37
• Burden of bacterial coinfections and AMR in people with
COVID-19, drivers and impact on clinical outcomes
• Use of Abx in people with COVID-19 and impact on
clinical outcome
AIM: Inform update of WHO COVID-19 Clinical Management
Guidelines
• Recommendation on the empirical use of antibiotics
in patients COVID-19

CORE Case Report Form (CRFs): AMR Module
MODULE 1
Admission
• Clinical inclusion
criteria
• Demographics
• Date of onset and
admission vital
signs
• Co-morbidities
• Signs and
symptoms on
admission
• Lab results
• Supportive care
received
• Medications/Abx
• _____________
• Pregnancy Status
upon Admission
MODULE 2
ICU Admission or
ICU Transfer
• Vital signs
• Daily clinical
features
• Lab results
• Medication/Abx
• Supportive care
received
• _____________
• Fetal Heart Rate
MODULE 3
Discharge or death
(Outcome)
• Co-Infections
• Pathogen isolation
• AMR patterns
• Antibiotics
• Supportive care received
• Co-diagnoses
• Clinical Outcome
• _____________
• Pregnancy Outcomes
June 2022
40
CRF updated in
November 2021

AMR among patients hospitalized with COVID-19
The AMR-related variables:
• Site of infection
• Bacteria isolation and type of
bacteria
• Multi-drug resistance bacteria
• MDRO colonization
• Antibiotics type administered at
hospital admission, at ICU
admission, during hospital stay
• Abx: empiric vs targeted
• Abx duration
• Fungal co-infection
Objectives:
• prevalence of co-infections and
secondary infections caused by
resistant bacteria or fungi
• risk factors associated with the
presence of co-infections and
MDRO isolation
• outcomes among patients with co-
infections and those receiving
empiric Abx therapy

June 2022
44
Post COVID-19 Condition
(Long COVID)

Ongoing analyses
June 2022
Systematic review and meta-analysis
Data curati
aggregation
analysis,
interpretat
clinical data from
subpopulations
TO INFORM THE IMPACT of EMPIRIC ANTIBIOTIC THERAPY ON
OUTCOMES OF PATIENTS WITH COVID-19
Data cura
aggregati
analysis,
interpret
clinical data from
subpopulations
Death ICU admissions Length of Hospitalization
Colonization by multi-drug resistant bacteria
Fungal Infections
Adverse events
WHO GUIDELINES
5
Post COVID-19 Condition (PCC, Long COVID)
• IHME estimates that 3.92 billion individuals were infected with SARS-CoV-2 through the end of 2021 and that 3.7 %
(144.7 million : 55 – 313) developed PCC as defined by the WHO case definition
• Three symptom clusters: fatigue, cognitive problems, and shortness of breath
• Females and those with more severe COVID-19 with more episodes of PCC
• Median duration 4 months (IQR 3.84-4.20) in community infections and 9 months (IQR 2.31 – 8.72) in
hospitalized patients.
• 15.1% (21 million) had persistent symptoms 12 months
• Average disability weight (DW’s) equivalent to DW’s for severe neck pain, Crohn’s disease, and long-term
consequences from traumatic brain injury
• Underlying pathophysiology still unclear and may include a hyperimmune response, coagulation/vasculopathy,
endocrine and autonomic dysregulation, and/or maladaptation of the ACE-2 pathway.
• Emerging evidence of organ damage related to COVID-19 causing cardiac disease, diabetes, and cognitive brain
loss
• Stress importance for integration of PCC care into primary care and using an integrated, multidisciplinary
care model.
https://www.medrxiv.org/content/10.1101/2022.05.26.22275532v1
https://apps.who.int/iris/handle/10665/345824

June 2022
46
Post COVID-19 Condition
(Long COVID)
2
Post COVID-19 condition
Milestones
6 October 2021
Webinar 3:
Expanding our understanding
of rehabilitation
9 February 2021
Webinar 1:
Expanding our
understanding of post
COVID-19 condition
15 June 2021
Webinar 2:
Understanding
mechanisms of post
COVID-19 condition
May 2021
Began work on post COVID-
19 core outcome set (COS)
April 2021
Began work on
post COVID-19 case
definition
6 October 2021
Post COVID-19 case definition
published at WHO
December 2021
WHO Steering Committee
met to discuss update to
clinical guidelines
September 2020
International
Classification of
Disease (ICD)
published
Post COVID-19
condition
1 March 2022
Webinar 4:
Expanding our understanding:
neurology and mental health
February 2022
Post COVID-19 core outcome
set (COS) published to pre-
print server

June 2022
Post COVID-19 condition
Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-
CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last
for at least 2 months and cannot be explained by an alternative diagnosis.
Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also
others and generally have an impact on everyday functioning.
Symptoms may be new onset following initial recovery from an acute COVID-19 episode or
persist from the initial illness. Symptoms may also fluctuate or relapse over time.
* A separate definition may be applicable to children
Published by WHO 6 October 2021
https://apps.who.int/iris/bitstream/handle/10665/345824/WHO-2019-nCoV-Post-COVID-19-
condition-Clinical-case-definition-2021.1-eng.pdf
Published in Lancet Infectious Diseases 21 December 2021
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00703-9/fulltext

From hospital
discharge
From acute illness
(individuals who were
managed at home for
COVID-19)
Initial
check in
4-8 weeks
If symptoms/signs do not persist:
follow up visit after 6 and 12 months from check-in
If symptoms/signs persist:
follow up visit after 3, 6, 9, 12 months from check-in
CRF for post COVID-19 condition:
administration
module 1, 2, 3 module 2, 3
Post COVID-19 Condition CRF

administration
Part 1: Demographics & Epidemiology of COVID-19
1. Complete once
2. Method of administration
- Face to face with patient by a healthcare worker (preferred)
- Self-administered
- Remote (online, telephone)
- Guardian

administration
Part 2: Follow-up evaluation
1. Complete every visit
2. Help identify patients who require further evaluation
- Face to face with patient by a healthcare worker (preferred)
- Self-administered
- Remote (online, telephone)
- Guardian

administration
Part 3: Clinical examination, laboratory tests, and
diagnosis during follow-up
1. Complete every visit
- Face to face with patient
- Completed by healthcare worker

Thank you
COVID_ClinPlatform@who.int
Bertagnolios@who.int
Kuppallik@who.int
https://www.who.int/teams/health-care-readiness-clinical-unit/covid-19/data-platform

Brazil Clinical Data Platform Slides 03_08_22.pdf

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Brazil Clinical Data Platform Slides 03_08_22.pdf