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NCT04514016 Clinical Trial

Cross Sectional CFAR HIV/COVID-19 Study

Covid19 Clinical Trial

Official title:
Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04514016
Other study ID # 20200802
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 12, 2020
Est. completion date March 17, 2021

Study information
Verified date March 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date March 17, 2021
Est. primary completion date March 17, 2021
Accepts healthy volunteers
Gender All
Age group 3 Years to 25 Years
Eligibility Inclusion Criteria: - Being a patient to the Pediatric or Adolescent clinic located at Batchelor Children Research Institute (BCRI) - Being diagnosed with HIV infection by the time of enrollment - At enrollment, 3 to < 26 years Exclusion Criteria: - Patient will be excluded from the study if any of the following are identified: - Patients under legal age and in the State's custody - Participant or legal guardian unable to sign Informed Consent forms - Participant unable to complete study visits

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Batchelor's Children's Research Institute Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Miami Miami Center for AIDS Research (CFAR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who tested positive with SARS COV-2 Infection SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay month 3
Primary Number of participants who tested positive with SARS COV-2 antibody SARS COV-2 antibody will be analyzed from blood samples via serological assay month 3
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