COVID-19IMPROVISENCT04473131
Immune Profiling of COVID19-patients Admitted to ICU
An observational study of COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 300 participants
- Where
- 1 siteQatar
- Study dates
- 27 Apr 2020to Jun 2022
- 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: In this study, we are targeting to enroll two categories of patients from ICU: 100 COVID19-positive patients, and 100 COVID19-negative patients. In addition to 100 healthy volunteers from the blood donation center.
Who may be able to join
- Admitted to ICU for suspicious COVID-19
- Signed consent form
Who cannot join
- Immuno-compromised or immuno-deficient patients
- Diagnosed with any immunological disorders, cancer, and onco-hematological diseases at the inclusion date
- Patients under treatment or treated within 5 years before inclusion or at the end of chemotherapy within the 6 months prior to inclusion date
- Patients under any immune-suppressive medications, antibody therapy, corticosteroids, bone marrow transplant under the last 6 months of inclusion
- Unsigned consent form
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Ali Ait Hssain, 44392488, a_aithssain@hotmail.com
Ali Ait Hssain
About this study
Official title: Immune Profiling of COVID-19-infected Patients Admitted to the Intensive Care Unit (ICU): the IMPROVISE Study
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients' prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients' outcomes.
- Conditions
- COVID-19
- Being tested
- No intervention
- Keywords
- COVID-19, SARS-CoV-2, ICU, Immune profiling, Humoral immunity, Cellular immunity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Only blood samples will be taken from participants for this study
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | Inclusion criteria:
1. Male or female aged over 18 years
2. Admitted patients to ICU with a suspicious COVID19 infection
3. Tested positive for SARS-CoV-2
Exclusion criteria:
1. Burn and trauma
2. Any immunological diseases, or immunosuppressive medications
3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible) Receives: Other: No intervention | |
| COVID-19 negative | Inclusion criteria:
1. Male or female aged over 18 years
2. Admitted patients to ICU
3. Tested negative for SARS-CoV-2
Exclusion criteria:
1. Burn and trauma
2. Any immunological diseases, or immunosuppressive medications
3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant)
Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible) Receives: Other: No intervention | |
| Heathy volunteers | Inclusion criteria:
1. Male or female aged over 18 years
2. Normal clinical examination
Exclusion criteria:
1. Person with an infectious syndrome during the last 90 days
2. Extreme physical stress within the last week
3. Person receiving within the last 90 days, a treatment based on: antivirals; antibiotics; antiparasitics; antifungals; non-steroidal anti-inflammatory drugs; immunosuppressive therapy; corticosteroids; therapeutic antibodies; chemotherapy
4. Person with history of: innate or acquired immune deficiency; hematological disease; solid tumor; severe chronic disease; surgery or hospitalization within the last 2 years; pregnancy within the last year; participation to a phase I clinical assay during the last year; participation to a phase I clinical assay during the last year; pregnant or breastfeeding women; a person with restricted liberty or under legal protection
Sample collection time points: 1 (day of blood sample donation) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create an immune profile for each COVID19-positive patient during their ICU stay
A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.
Measured: 8 to 12 months
To correlate patients' immune profile to disease severity and patient's outcome
A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start27 Apr 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qatar University, Weill Cornell Medical College in Qatar
- Responsible party
- Principal investigator, Ali Ait Hssain, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473131
- Sponsor's protocol ID
- MRC-05-007
- Acronym
- IMPROVISE
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bradic M, Taleb S, Thomas B, Chidiac O, Robay A, Hassan N, Malek J, Ait Hssain A, Abi Khalil C. DNA methylation predicts the outcome of COVID-19 patients with acute respiratory distress syndrome. J Transl Med. 2022 Nov 12;20(1):526. doi: 10.1186/s12967-022-03737-5.
PubMed 36371196
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profiling of COVID-19-infected Patients Admitted to the Intensive Care Unit (ICU): the IMPROVISE Study
- ClinicalTrials.gov ID
- NCT04473131
- Acronym / sponsor ID
- IMPROVISE / MRC-05-007
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, ICU, Immune profiling, Humoral immunity, Cellular immunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Qatar University, Weill Cornell Medical College in Qatar
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Jul 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.
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients' prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients' outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Other: No interventionInclusion criteria: 1. Male or female aged over 18 years 2. Admitted patients to ICU with a suspicious COVID19 infection 3. Tested positive for SARS-CoV-2 Exclusion criteria: 1. Burn and trauma 2. Any immunological diseases, or immunosuppressive medications 3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant) Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible) |
| COVID-19 negative | – | Other: No interventionInclusion criteria: 1. Male or female aged over 18 years 2. Admitted patients to ICU 3. Tested negative for SARS-CoV-2 Exclusion criteria: 1. Burn and trauma 2. Any immunological diseases, or immunosuppressive medications 3. Other immune-related conditions (cancer, hematological malignancies, bone marrow diseases or transplant) Sample collection time points: 4 to 5 (day 1-3, day 7, day 14, day 21, discharge day from ICU -between day 30-60- if possible) |
| Heathy volunteers | – | Other: No interventionInclusion criteria: 1. Male or female aged over 18 years 2. Normal clinical examination Exclusion criteria: 1. Person with an infectious syndrome during the last 90 days 2. Extreme physical stress within the last week 3. Person receiving within the last 90 days, a treatment based on: antivirals; antibiotics; antiparasitics; antifungals; non-steroidal anti-inflammatory drugs; immunosuppressive therapy; corticosteroids; therapeutic antibodies; chemotherapy 4. Person with history of: innate or acquired immune deficiency; hematological disease; solid tumor; severe chronic disease; surgery or hospitalization within the last 2 years; pregnancy within the last year; participation to a phase I clinical assay during the last year; participation to a phase I clinical assay during the last year; pregnant or breastfeeding women; a person with restricted liberty or under legal protection Sample collection time points: 1 (day of blood sample donation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we are targeting to enroll two categories of patients from ICU: 100 COVID19-positive patients, and 100 COVID19-negative patients. In addition to 100 healthy volunteers from the blood donation center.
Key inclusion criteria (2 listed)
- Admitted to ICU for suspicious COVID-19
- Signed consent form
Key exclusion criteria (5 listed)
- Immuno-compromised or immuno-deficient patients
- Diagnosed with any immunological disorders, cancer, and onco-hematological diseases at the inclusion date
- Patients under treatment or treated within 5 years before inclusion or at the end of chemotherapy within the 6 months prior to inclusion date
- Patients under any immune-suppressive medications, antibody therapy, corticosteroids, bone marrow transplant under the last 6 months of inclusion
- Unsigned consent form
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 |
|---|---|---|
| No interventionOnly blood samples will be taken from participants for this study | Other | COVID-19 negative, COVID-19 positive, Heathy volunteers |
Primary outcome
To create an immune profile for each COVID19-positive patient during their ICU stay
Time frame: 8 to 12 months
A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.
To correlate patients' immune profile to disease severity and patient's outcome
Time frame: 4 to 6 months
A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 36371196Bradic M, Taleb S, Thomas B, Chidiac O, Robay A, Hassan N, Malek J, Ait Hssain A, Abi Khalil C. DNA methylation predicts the outcome of COVID-19 patients with acute respiratory distress syndrome. J Transl Med. 2022 Nov 12;20(1):526. doi: 10.1186/s12967-022-03737-5.
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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.
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 COVID-19, run by Hamad Medical Corporation at 1 site in Qatar.
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 2 inclusion and 5 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 16 Jul 2020. 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 Qatar. 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 Dr. Ali Ait Hssain (77172526, a_aithssain@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create an immune profile for each COVID19-positive patient during their ICU stay (time frame: 8 to 12 months). 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?
On the ClinicalTrials.gov record for NCT04473131, which also lists 1 linked publication.
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 16 Jul 2020.