PLWHNCT06172816
A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2
An observational study of PLWH and Covid-19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PLWH, Covid-19, Clinical Features
- What is being tested?
- SARS-CoV-2
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people and people living with HIV which is immunodeficient.
Who may be able to join
- Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines.
Who cannot join
- Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, 400010
Wang Na, doctor, 13883905803, laguren300@163.com
About this study
Official title: 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.
- Conditions
- PLWH, Covid-19, Clinical Features, Prognosis
- Being tested
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2Other
a virus infection
| Study group | Role | What they receive |
|---|---|---|
| PLWH | the people living with HIV Receives: Other: SARS-CoV-2 | |
| HC | the people without disease Receives: Other: SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical features and prognosis
the clinical features and prognosis between healthy people and PLWH infected with Omicron
Measured: 2022.11-2023.1
antibody titer
the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron
Measured: 2022.11-2023.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PLWHStudies 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
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172816
- Sponsor's protocol ID
- 2023IITxG12
- Status last verified
- Jan 2023
- First submitted
- 10 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT06172816
- Acronym / sponsor ID
- 2023IITxG12
- Conditions
- PLWH, Covid-19, Clinical Features, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLWH | – | Other: SARS-CoV-2the people living with HIV |
| HC | – | Other: SARS-CoV-2the people without disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people and people living with HIV which is immunodeficient.
Key inclusion criteria (1 listed)
- Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines.
Key exclusion criteria (1 listed)
- Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2a virus infection | Other | HC, PLWH |
Primary outcome
clinical features and prognosis
Time frame: 2022.11-2023.1
the clinical features and prognosis between healthy people and PLWH infected with Omicron
antibody titer
Time frame: 2022.11-2023.1
the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
The second affiliated hospital of Chongqing medical university
Chongqing, China
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 PLWH and Covid-19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical features and prognosis (time frame: 2022.11-2023.1). 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 15 Dec 2023.