- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172816
A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2
December 13, 2023 updated by: The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
On February 11th, 2020, the International Classification of Viruses named the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as novel coronavirus (COVID-19, Covid-19 for short).
At present, COVID-19 has become a global pandemic.
However, the persistent replication of HIV in PLWH and the cellular immunodeficiency and persistent inflammation caused by it may have different effects on the susceptibility, severity and course of Covid-19.
Several large cohort studies have found evidence of increased risk of hospitalization and death in patients with HIV and Covid-19 co-infection.
Meanwhile, a meta-analysis of 22 studies shows that HIV infection is still an important risk factor for acquiring Covid-19 infection, and it is associated with a higher risk of death in COVID-19.
In order to further clarify the clinical features and prognosis of HIV co-infection with Covid-19 and explore its immune mechanism, so we will carry out the study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
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
-
-
Chongqing
-
Chongqing, Chongqing, China, 400010
- Recruiting
- The Second Affiliated Hospital of Chongqing Medical University
-
Contact:
- Wang Na, doctor
- Phone Number: 13883905803
- Email: laguren300@163.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy people and people living with HIV which is immunodeficient.
Description
Inclusion Criteria:
- Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines.
Exclusion Criteria:
- Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.
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 |
Intervention / Treatment |
---|---|
PLWH
the people living with HIV
|
a virus infection
|
HC
the people without disease
|
a virus infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical features and prognosis
Time Frame: 2022.11-2023.1
|
the clinical features and prognosis between healthy people and PLWH infected with Omicron
|
2022.11-2023.1
|
antibody titer
Time Frame: 2022.11-2023.1
|
the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron
|
2022.11-2023.1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
December 10, 2023
First Submitted That Met QC Criteria
December 13, 2023
First Posted (Estimated)
December 15, 2023
Study Record Updates
Last Update Posted (Estimated)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2023IITxG12
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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