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HIV/COV in Ukraine-NL

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ClinicalTrials.gov Identifier: NCT04711954
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Lviv Regional AIDS Health Center
Information provided by (Responsible Party):
Casper Rokx, Erasmus Medical Center

Study Description
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Brief Summary:
Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands.

Condition or disease
Hiv Covid19

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: COVID-19 in People Living With HIV in Light of the 90-90-90 Goals: A Netherlands/Ukraine Research Collaboration.
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
ATHENA
Cohort of people living with HIV in the Netherlands
LUKCY
Cohort of people living with HIV in the Lviv area, Ukraine


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence COVID19 [ Time Frame: Up to 2 years ]
    Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.


Secondary Outcome Measures :
  1. Incidence COVID-19 [ Time Frame: Up to 2 years ]
    Incidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands

  2. WHO categories COVID-19 [ Time Frame: Up to 2 years ]
    Prevalence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.

  3. WHO categories COVID-19 [ Time Frame: Up to 2 years ]
    Incidence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.

  4. WHO disease severity COVID-19 [ Time Frame: Up to 2 years ]
    Proportion of COVID-19 patients according to the severity of COVID-19 on an adapted World Health Organisation 5 point disease severity scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal) in people with HIV cohorts from Ukraine and the Netherlands.

  5. Seroprevalence [ Time Frame: Up to 2 years ]
    Anti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands

  6. NPV/PPV WHO categories COVID19 [ Time Frame: Up to 2 years ]
    Positive and negative predictive value of the WHO COVID-19 case probability categories on anti-SARSCOV2 serology in PWH cohort from Ukraine

  7. Treatment [ Time Frame: Up to 2 years ]
    Description of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands

  8. Predictors for COVID-19 [ Time Frame: Up to 2 years ]
    Predictor variables for having clinical COVID-19 in PWH cohorts from Ukraine and the Netherlands according to 1) sex, 2) age categories (<50, 50-70, >70), 3) ART (LPV/r vs other and TDF containing vs non-TDF containing regimens), 4) most recent CD4+T-cell 5) HIV-RNA suppressed (<=50 / >50), 6) prior TB, 7) prior BCG, 8) HIV transmission group, 9) comorbidities (0 vs 1 vs >1).

  9. Predictors for COVID-19 severity [ Time Frame: Up to 2 years ]
    Predictor variables for the highest score on an ordinal scale for COVID-19 severity according to the adapted 5point WHO severity scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal) in PWH cohorts from Ukraine and the Netherlands according to 1) sex, 2) age categories (<50, 50-70, >70), 3) ART (LPV/r vs other and TDF containing vs non-TDF containing regimens), 4) most recent CD4+T-cell 5) HIV-RNA suppressed (<=50 / >50), 6) prior TB, 7) prior BCG, 8) HIV transmission group, 9) comorbidities (0 vs 1 vs >1)


Other Outcome Measures:
  1. HIV vs non-HIV [ Time Frame: Up to 2 years ]
    Correlation of HIV status with the highest score on an ordinal scale for COVID-19 severity according to the adapted 5point WHO severity scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal) in matched PWH cases with HIV uninfected controls by age, sex and comorbidities.

  2. PPV/NPV WHO categories COVID-19 [ Time Frame: Up to 2 years ]
    Positive and negative predictive value of the WHO COVID-19 case probability categories in the prior 3 months on anti-SARSCOV2 serology in PWH cohort from Ukraine

  3. Effect of socio-economic status by questionnaire on COVID-19 incidence [ Time Frame: Up to 2 years ]
    Evaluate the impact of social economic status on COVID-19 incidence.

  4. Effect of socio-economic status on COVID-19 severity [ Time Frame: Up to 2 years ]
    Evaluate the impact of social economic status on COVID-19 severity according to WHO 5 point scale (where 1=no symptoms, 2=symptoms but outpatient, 3=admitted to hospital, 4=admitted to ICU, 5=fatal)

  5. Symptoms [ Time Frame: Up to 2 years ]
    Describe symptoms associated with COVID probability in PWH cohorts from Ukraine and the Netherlands

  6. Rapid Ag test [ Time Frame: Up to 2 years ]
    Evaluate the PPV/NPV of the rapid antigen test in PWH with symptoms suspected of COVID-19 in Ukraine and the Netherlands


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
People with HIV from patient cohorts in the Netherlands and Ukraine. All participants will be systematically included consecutively.
Criteria

Inclusion Criteria:

HIV infected No registered objection to use of data

Exclusion Criteria:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711954


Contacts
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Contact: Casper Rokx, MD PhD 0681336328 c.rokx@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CN
Contact: Casper Rokx, MD PhD    0681336328    c.rokx@erasmusmc.nl   
Sub-Investigator: Albert Groenendijk, MD         
Ukraine
Lviv Regional AIDS Health Center Recruiting
Lviv, Ukraine
Contact: Marta Vasylyev, MD       marta.vasylyev@astar.com.ua   
Sponsors and Collaborators
Erasmus Medical Center
Lviv Regional AIDS Health Center
More Information
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Responsible Party: Casper Rokx, MD PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04711954    
Other Study ID Numbers: 1990 Study
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Other research group can contact the PI with a research question to gain access to IPD.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be kept up to 15 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases