A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2

NCT06172816 | Unknown DMC

• 1 other identifier: 2023IITxG12
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PLWH; Covid-19; Clinical Features; Prognosis

Outcome Measures

Primary Outcomes (2)

• clinical features and prognosis

  the clinical features and prognosis between healthy people and PLWH infected with Omicron

  2022.11-2023.1

• antibody titer

  the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron

  2022.11-2023.1

Study Arms (2)

PLWH

the people living with HIV

Other: SARS-CoV-2

HC

the people without disease

Other: SARS-CoV-2

Interventions

SARS-CoV-2 OTHER

a virus infection

HC; PLWH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy people and people living with HIV which is immunodeficient.

You may qualify if:

• Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines.

You may not qualify if:

• Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The second affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 15, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-01

Locations

CN (1)