Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04552340 |
| Other study ID # |
2485 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 16, 2020 |
| Est. completion date |
July 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Istituto Clinico Humanitas |
| Contact |
Maurizio Cecconi |
| Phone |
0282244151 |
| Email |
maurizio.cecconi[@]hunimed.eu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main purpose of this study is to identify possible predictor factor of mortality in
patients affected by COVID-19 with respiratory failure needing oxygen therapy or ventilatory
support. In addiction the study aims to identify factors related to: predisposition to
SARS-CoV2 viral infection, different symptoms, response to therapy, predisposition to
complications related to the disease. To this end, the haemodynamic parameters and all
imaging reports will be evaluated and clinical and laboratory tests as well as cellular and
molecular analyzes will be performed in the analyzed patients. In addition, investigations
will be carried out on the profile of the alveolar or nasal microbiota and, if possible, of
the metabolic products, and estimates on antibody titers.
Description:
The study is a cohort study with retrospective-prospective data collection. All the clinical
data collected in the study are usually monitored in the clinical practice and no additional
clinical exams will be required for the sole purpose of the study.
Patients will be asked consent for the research use of blood and bronchial lavage/residual
samples from nasopharyngeal swabs to perform cellular and molecular analyses aimed at better
understanding the disease pathogenesis and the individual differences in susceptibility to
the disease. These experiments will have no direct impact on the clinical management of
patients. It is impossible to detail now all the experiments that will be performed on stored
samples. It is possible to anticipate that samples could be used to analyze the immune
response by studying immune cells and soluble mediators of the immune response. Moreover,
samples will be used to extract nucleic acids to analyze gene expression profiles and DNA
variations possibly related with disease susceptibility. Part of the genetic studies could be
conducted in other laboratories abroad (i.e. the Institute of Clinical Molecular Biology of
the Christian-Albrechts-University of Kiel and the Institute of Clinical Medicine of the
University of Oslo) as part of scientific collaborations. In particular, the investigators
plan to study the expression levels of molecules known to mediated viral infection, like the
Angiotensin converting enzyme 2 (ACE2) and the Transmembrane protease, serine 2 enzyme
(TMPRSS2). Genetic variants in these genes, and more in general in other genes in the genome,
could be related to susceptibility to the viral infection and/or to the severity of the
clinical course of the disease. Therefore, the investigators plan to compare the frequency of
genetic variants potentially related with COVID-19 susceptibility/severity in different
subgroups of patients, ranging from individuals positive for the virus but asymptomatic to
individuals affected by COVID-19 with ARDS requiring admission to ICU. The extension of the
analyses that will be performed can't be anticipated as it depends also on the amount of
funding that will be available to the study; potentially the entire genome could be analyzed.
Original sepsis and ARDS biomarkers developed at ICH (e.g. PTX3, sIL-1R2, MSF) will be used
to address their prognostic potential in COVID-19 patients. PBMC will be analyzed by FACS to
investigate the immunophenotype and correlate it to the clinical outcome. Original markers of
leukocyte functional activation developed at ICH will be included in the analysis (e.g.
IL-1R8, IL-1R2). The residual BAL and rhinopharyngeal swab will be used for microbiota
analysis, metabolomics and cytokine measurement. Plasma and saliva/sputum will be used also
to test anti-SARS-Cov-2 antibodies (IgM, IgG and IgA) and for microbiota analysis.
In order to better describe the populations of COVID-19 patients treated at our hospital, it
is necessary to collect disease outcome data over a short, medium and long-term follow-up
process. The investigators aim to understand how disease and intensive treatments affect the
lives of recovering patients. In particular, the investigators want to explore the
health-related quality of life, the impact of the disease on a psychological level, the
residual cardio-respiratory functional capacity and muscle strength. All the tests chosen are
common use tests in the follow-up of critically ill patients in particular with acute
respiratory distress syndrome.
The health-related quality of the life will be measured with the validated international
questionnaire EQ-5D-5L, in its Italian validated form. The questionnaire is attached, and has
been authorized for free non-commercial use by the EuroQuol consortium.
As a screening tool to evaluate the presence of psychological symptoms, such as anxiety and
depression, the Hospital Anxiety and Depression Scale (HADS) questionnaire will be
administered in its Italian version.
The cardio-respiratory functional capacity will be measured with the Six-Minutes Walk Test,
following the international guidelines published by the American Thoracic Society.
The single breath count tets will be performed, as well. It consists in the ability to count
from zero to twenty after a single maximum inspiration.
Finally, dynamic tests such as the Timed Up-and-Go (TUG) test and the Short physical
performance battery (SPPB) test will be performed to evaluate muscle strength, in particular
of the lower limbs, the ability to balance while walking and the general mobility of
patients. Both the aforementioned tests re internationally validated and are commonly used in
the evaluation of the functional reserve of patients in the geriatric and rehabilitation
setting. All this tests can be administered to patients during their hospital stay or after
their discharge at scheduled appointments.
