NCT04473131

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

July 15, 2020

Last Update Submit

July 15, 2020

Conditions

COVID-19

Keywords

COVID-19SARS-CoV-2ICUImmune profilingHumoral immunityCellular immunity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 to 6 months

Study Arms (3)

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)

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)

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)

Other: No intervention

Interventions

No interventionOTHER

Only blood samples will be taken from participants for this study

COVID-19 negativeCOVID-19 positiveHeathy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Admitted to ICU for suspicious COVID-19
  • Signed consent form

You may not qualify if:

  • Immuno-compromised or immuno-deficient patients
  • Unsigned consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36371196DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples Yellow SST blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Dr. Ali Ait Hssain

CONTACT

77172526a_aithssain@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant intensivist

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 16, 2020

Study Start

April 27, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

QA(1)