SARS-CoV InfectionNCT04514016
Cross Sectional CFAR HIV/COVID-19 Study
An observational study of SARS-CoV Infection and Covid19, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- SARS-CoV Infection, Covid19
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 17 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 25 years
- All sexes
- Child, Adult
Study population: HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children Research Institute (BCRI) at the University of Miami.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Batchelor's Children's Research Institute
Miami, Florida, 33136
About this study
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
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.
- Conditions
- SARS-CoV Infection, Covid19
- Keywords
- HIV
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: month 3
Number of participants who tested positive with SARS COV-2 antibody
SARS COV-2 antibody will be analyzed from blood samples via serological assay
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start12 Aug 2020
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Miami Center for AIDS Research (CFAR)
- Responsible party
- Principal investigator, Charles Mitchell, University of Miami
- Investigators
- Charles Mitchell, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514016
- Sponsor's protocol ID
- 20200802
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04514016
- Acronym / sponsor ID
- 20200802
- Conditions
- SARS-CoV Infection, Covid19
- Keywords
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Miami Center for AIDS Research (CFAR)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children Research Institute (BCRI) at the University of Miami.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Mitchell, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who tested positive with SARS COV-2 Infection (time frame: month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.