Covid19CoVIHDisNCT04526977
Differences in Immune Response Among HIV-1-infected Individuals With Previous or Current COVID-19 (CoVIHDis).
An observational study of Covid19 and Immune Suppression, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
Trial summary
People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19, Immune Suppression, HIV-1-infection
- What is being tested?
- Immune response study
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2021to 30 Mar 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients in regular follow up
Who may be able to join
- adult (>18 year-old), confirmed HIV-1-infection, and provide written informed consent, with previous SARS CoV-2 infection as demonstrated by clinical and a positive PCR (cases) or no previous compatible symptoms and no diagnosis of SARS-CoV-2 infection (controls, classified according to serological determination)
Who cannot join
- unable to provide a written informed consent.
- immunological alterations (chronic intake of corticoid or immunosuppresants)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Ramon y Cajal
Madrid, 28034
Jose L Casado, Md, PhD, 34913368790, jcasado.hrc@salud.madrid.org
Alejandro Vallejo, MD, PhD
About this study
Official title: Differences in Susceptibility and Cytokine Profile, Specific CD4/CD8 T Cell Response, Toll Like Receptors (TLRs) and Killer Immunoglobulin-like Receptors (KIRs) Among HIV-1-infected Individuals With Previous or Current COVID-19
People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infection could have different cytokine profile and cellular immune response after SARS-CoV-2 infection, leading to a differential outcome,
Read the detailed description
Since March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected almost five million people in 168 countries on five continents, with more than 300.000 deaths (1-4). The scientific evidence so far does not suggest that people with HIV-1 have an increased risk of serious complications if they develop COVID-19 disease (5-7). In our recent work, we have shown in a few patients that people with HIV-1 under antiretroviral treatment, with undetectable viral load and a CD4 count greater than 200 cells/mm3, do not have a higher risk of developing serious complications than people without HIV-1, but also HIV-1 infected patients does not seem to be protected of the so-called cytokine storm (8-11). Like in the general population, they would be more likely to develop serious complications if they are older and with previous pathologies (comorbidity), such as high blood pressure, diabetes, cardiovascular disease, chronic lung disease, cancer or immunosuppression (congenital, acquired or due to treatment with immunosuppressive drugs). Thus, people with HIV-1 who are immunocompromised with a CD4 count less than 200 cells/mm3, regardless of whether or not they take antiretroviral treatment should be considered among the vulnerable groups and therefore at an increased risk of developing serious clinical complications associated to COVID-19 (12-14). It should be noted, however, that, so far, there is no enough scientific evidence that can confirm this possibility (10,15-17).
Since March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected almost five million people in 168 countries on five continents, with more than 300.000 deaths (1-4). The scientific evidence so far does not suggest that people with HIV-1 have an increased risk of serious complications if they develop COVID-19 disease (5-7). In our recent work, we have shown in a few patients that people with HIV-1 under antiretroviral treatment, with undetectable viral load and a CD4 count greater than 200 cells/mm3, do not have a higher risk of developing serious complications than people without HIV-1, but also HIV-1 infected patients does not seem to be protected of the so-called cytokine storm (8-11). Like in the general population, they would be more likely to develop serious complications if they are older and with previous pathologies (comorbidity), such as high blood pressure, diabetes, cardiovascular disease, chronic lung disease, cancer or immunosuppression (congenital, acquired or due to treatment with immunosuppressive drugs). Thus, people with HIV-1 who are immunocompromised with a CD4 count less than 200 cells/mm3, regardless of whether or not they take antiretroviral treatment should be considered among the vulnerable groups and therefore at an increased risk of developing serious clinical complications associated to COVID-19 (12-14). It should be noted, however, that, so far, there is no enough scientific evidence that can confirm this possibility (10,15-17).
Indeed, there are two main questions for the management of this disease in this population, the real incidence of COVID 19 (susceptibility) and if the immune response could be different in those who were already coinfected.
- The differences in susceptibility to infection could be related to host factors. Thus, it is important to characterize and genotyping the main receptor for SARS-CoV-2, ACE2, and other related receptor, such as CD26, to explore the genetic background affecting the real incidence of this disease, along CD4 count and antiretroviral therapy.
- People with HIV-1 have an impaired immune system, especially in those with less than 200 CD4 cells/mm3. Hence, the immune response in these individuals could be weaker than in general population, including the cytokine response reported after SARS-CoV-2 infection (18-20). In addition, the specific CD4/CD8 T cell response could be altered due to the HIV-1 infection and the level of immunosuppression. This specific T cell response could be a good marker for the presence or persistence of immunity against SARS-CoV-2 infections.
In addition, the first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations. However, there are no data about TLRs activation and KIRs binding in HIV infected patients with SARS CoV-2 infection.
This project is designed to improve scientific knowledge and give answers to the actual clinical questions regarding SARS-CoV-2 infection in people living with HIV-1. It could be of importance to determine the risk of infection not related to HIV-related factors, and to ascertain the adequation of the immune response of HIV infected patients after a SARS-CoV-2, identifying therefore those at risk of severe disease.
- Conditions
- Covid19, Immune Suppression, HIV-1-infection
- Being tested
- Immune response study
- Keywords
- HIV, 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.
Immune response studyDiagnostic test
- ACE2 and CD26 receptor study
- Cytokine profile: Quantification of plasma cytokine levels
- SARS-CoV-2 CD4/CD8 T cell response
- TLR7/8 activation
- KIR characterization
| Study group | Role | What they receive |
|---|---|---|
| Cases | HIV-1 infected individuals with previous or current diagnosis of SARS-CoV-2 infection, defined as the presence of suggestive symptoms and a positive PCR from the nasopharyngeal swab. Receives: Diagnostic Test: Immune response study | |
| Controls | HIV-1-infected individuals of the same age (range, 5 years) and sex, who not have been diagnosed of clinical (asymptomatic) or confirmed SARS CoV-2 infection, but were positive for IgG antibodies (controls group 1) or with no evidence of SARS-CoV-2 infection (no previous neither current symptoms, negative for IgM/IgG antibodies, controls group 2) Receives: Diagnostic Test: Immune response study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immune cellular response
Differences in cellular response to SARS-COV-2 peptides
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start10 Jan 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jose L Casado, PhD, Principal investigator, Hospital Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526977
- Sponsor's protocol ID
- EC 273/20
- Acronym
- CoVIHDis
- Status last verified
- Oct 2022
- First submitted
- 22 Aug 2020
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Susceptibility and Cytokine Profile, Specific CD4/CD8 T Cell Response, Toll Like Receptors (TLRs) and Killer Immunoglobulin-like Receptors (KIRs) Among HIV-1-infected Individuals With Previous or Current COVID-19
- ClinicalTrials.gov ID
- NCT04526977
- Acronym / sponsor ID
- CoVIHDis / EC 273/20
- Conditions
- Covid19, Immune Suppression, HIV-1-infection
- Keywords
- HIV, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Asociacion para el Estudio de las Enfermedades InfecciosasResearch network
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 26 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.
People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infection could have different cytokine profile and cellular immune response after SARS-CoV-2 infection, leading to a differential outcome,
Detailed description
Since March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected almost five million people in 168 countries on five continents, with more than 300.000 deaths (1-4). The scientific evidence so far does not suggest that people with HIV-1 have an increased risk of serious complications if they develop COVID-19 disease (5-7). In our recent work, we have shown in a few patients that people with HIV-1 under antiretroviral treatment, with undetectable viral load and a CD4 count greater than 200 cells/mm3, do not have a higher risk of developing serious complications than people without HIV-1, but also HIV-1 infected patients does not seem to be protected of the so-called cytokine storm (8-11). Like in the general population, they would be more likely to develop serious complications if they are older and with previous pathologies (comorbidity), such as high blood pressure, diabetes, cardiovascular disease, chronic lung disease, cancer or immunosuppression (congenital, acquired or due to treatment with immunosuppressive drugs). Thus, people with HIV-1 who are immunocompromised with a CD4 count less than 200 cells/mm3, regardless of whether or not they take antiretroviral treatment should be considered among the vulnerable groups and therefore at an increased risk of developing serious clinical complications associated to COVID-19 (12-14). It should be noted, however, that, so far, there is no enough scientific evidence that can confirm this possibility (10,15-17).
Since March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected almost five million people in 168 countries on five continents, with more than 300.000 deaths (1-4). The scientific evidence so far does not suggest that people with HIV-1 have an increased risk of serious complications if they develop COVID-19 disease (5-7). In our recent work, we have shown in a few patients that people with HIV-1 under antiretroviral treatment, with undetectable viral load and a CD4 count greater than 200 cells/mm3, do not have a higher risk of developing serious complications than people without HIV-1, but also HIV-1 infected patients does not seem to be protected of the so-called cytokine storm (8-11). Like in the general population, they would be more likely to develop serious complications if they are older and with previous pathologies (comorbidity), such as high blood pressure, diabetes, cardiovascular disease, chronic lung disease, cancer or immunosuppression (congenital, acquired or due to treatment with immunosuppressive drugs). Thus, people with HIV-1 who are immunocompromised with a CD4 count less than 200 cells/mm3, regardless of whether or not they take antiretroviral treatment should be considered among the vulnerable groups and therefore at an increased risk of developing serious clinical complications associated to COVID-19 (12-14). It should be noted, however, that, so far, there is no enough scientific evidence that can confirm this possibility (10,15-17).
Indeed, there are two main questions for the management of this disease in this population, the real incidence of COVID 19 (susceptibility) and if the immune response could be different in those who were already coinfected.
- The differences in susceptibility to infection could be related to host factors. Thus, it is important to characterize and genotyping the main receptor for SARS-CoV-2, ACE2, and other related receptor, such as CD26, to explore the genetic background affecting the real incidence of this disease, along CD4 count and antiretroviral therapy.
- People with HIV-1 have an impaired immune system, especially in those with less than 200 CD4 cells/mm3. Hence, the immune response in these individuals could be weaker than in general population, including the cytokine response reported after SARS-CoV-2 infection (18-20). In addition, the specific CD4/CD8 T cell response could be altered due to the HIV-1 infection and the level of immunosuppression. This specific T cell response could be a good marker for the presence or persistence of immunity against SARS-CoV-2 infections.
In addition, the first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations. However, there are no data about TLRs activation and KIRs binding in HIV infected patients with SARS CoV-2 infection.
This project is designed to improve scientific knowledge and give answers to the actual clinical questions regarding SARS-CoV-2 infection in people living with HIV-1. It could be of importance to determine the risk of infection not related to HIV-related factors, and to ascertain the adequation of the immune response of HIV infected patients after a SARS-CoV-2, identifying therefore those at risk of severe disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Immune response studyHIV-1 infected individuals with previous or current diagnosis of SARS-CoV-2 infection, defined as the presence of suggestive symptoms and a positive PCR from the nasopharyngeal swab. |
| Controls | – | Diagnostic Test: Immune response studyHIV-1-infected individuals of the same age (range, 5 years) and sex, who not have been diagnosed of clinical (asymptomatic) or confirmed SARS CoV-2 infection, but were positive for IgG antibodies (controls group 1) or with no evidence of SARS-CoV-2 infection (no previous neither current symptoms, negative for IgM/IgG antibodies, controls group 2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients in regular follow up
Key inclusion criteria (1 listed)
- adult (>18 year-old), confirmed HIV-1-infection, and provide written informed consent, with previous SARS CoV-2 infection as demonstrated by clinical and a positive PCR (cases) or no previous compatible symptoms and no diagnosis of SARS-CoV-2 infection (controls, classified according to serological determination)
Key exclusion criteria (2 listed)
- unable to provide a written informed consent.
- immunological alterations (chronic intake of corticoid or immunosuppresants)
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 |
|---|---|---|
| Immune response study* ACE2 and CD26 receptor study * Cytokine profile: Quantification of plasma cytokine levels * SARS-CoV-2 CD4/CD8 T cell response * TLR7/8 activation * KIR characterization | Diagnostic test | Cases, Controls |
Primary outcome
Changes in immune cellular response
Time frame: 3 months
Differences in cellular response to SARS-COV-2 peptides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Covid19
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
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.
Jose L Casado, PhD principal investigator
Hospital Ramon y Cajal
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 Covid19 and Immune Suppression, run by Asociacion para el Estudio de las Enfermedades Infecciosas at 1 site in Spain.
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 2 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 18 Oct 2022. 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 Spain. 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?
Contact Jose L Casado, PhD (0034913368672, jcasado.hrc@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in immune cellular response (time frame: 3 months). 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 18 Oct 2022.