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

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:

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
Other: SARS-CoV-2
a virus infection
HC
the people without disease
Other: SARS-CoV-2
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.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

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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