HIV/COV in Ukraine-NL

Covid19 Clinical Trial

Official title:

COVID-19 in People Living With HIV in Light of the 90-90-90 Goals: A Netherlands/Ukraine Research Collaboration.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04711954
• Other study ID #: 1990 Study
• Status: Active, not recruiting
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

HIV infected No registered objection to use of data

Exclusion Criteria:

None

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hiv

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam
Ukraine	Lviv Regional AIDS Health Center	Lviv

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Lviv Regional AIDS Health Center

Countries where clinical trial is conducted

Netherlands,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV vs non-HIV	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.	Up to 2 years
Other	PPV/NPV WHO categories COVID-19	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	Up to 2 years
Other	Effect of socio-economic status by questionnaire on COVID-19 incidence	Evaluate the impact of social economic status on COVID-19 incidence.	Up to 2 years
Other	Effect of socio-economic status on COVID-19 severity	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)	Up to 2 years
Other	Symptoms	Describe symptoms associated with COVID probability in PWH cohorts from Ukraine and the Netherlands	Up to 2 years
Other	Rapid Ag test	Evaluate the PPV/NPV of the rapid antigen test in PWH with symptoms suspected of COVID-19 in Ukraine and the Netherlands	Up to 2 years
Primary	Prevalence COVID19	Prevalence (percent) of clinical COVID-19 in PWH cohorts from Ukraine and in the Netherlands.	Up to 2 years
Secondary	Incidence COVID-19	Incidence (nr cases/person years) of clinical COVID-19 cases in PWH cohorts from Ukraine and in the Netherlands	Up to 2 years
Secondary	WHO categories COVID-19	Prevalence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.	Up to 2 years
Secondary	WHO categories COVID-19	Incidence of no suspicion, possible, probable and proven COVID-19 cases in the past 6 months PWH cohorts from Ukraine and the Netherlands.	Up to 2 years
Secondary	WHO disease severity COVID-19	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.	Up to 2 years
Secondary	Seroprevalence	Anti-SARSCOV2 seroprevalence in PWH cohorts from Ukraine and the Netherlands	Up to 2 years
Secondary	NPV/PPV WHO categories COVID19	Positive and negative predictive value of the WHO COVID-19 case probability categories on anti-SARSCOV2 serology in PWH cohort from Ukraine	Up to 2 years
Secondary	Treatment	Description of COVID-19 therapeutic management in PWH cohorts from Ukraine and the Netherlands	Up to 2 years
Secondary	Predictors for COVID-19	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).	Up to 2 years
Secondary	Predictors for COVID-19 severity	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)	Up to 2 years