- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514016
Cross Sectional CFAR HIV/COVID-19 Study
March 22, 2021 updated by: Charles Mitchell, University of Miami
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Batchelor's Children's Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children Research Institute (BCRI) at the University of Miami.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
HIV positive participants with positive COVID-19 results
Participants in this group will have a RT-PCR and Coronavirus Disease (COVID) -19 specific antibody testing at baseline, 1 month and 3 month visits.
|
HIV positive participants with negative COVID-19 results
Participants in this group will have a RT-PCR and COVID-19 specific antibody testing at baseline only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who tested positive with SARS COV-2 Infection
Time Frame: month 3
|
SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay
|
month 3
|
Number of participants who tested positive with SARS COV-2 antibody
Time Frame: month 3
|
SARS COV-2 antibody will be analyzed from blood samples via serological assay
|
month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Mitchell, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2020
Primary Completion (Actual)
March 17, 2021
Study Completion (Actual)
March 17, 2021
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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