Covid 19 Research using Clinical Trials (Home Page)
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There is one clinical trial.
Clinical Trials
Whereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30%
of patients with a 30%-60% mortality rate for those requiring hospitalization in an intensive
care unit. The main physio-pathological hallmark is an acute pulmonary inflammation.
Currently, there is no treatment.
Mesenchymal stem cells (MSC) feature several attractive characteristics: ease of procurement,
high proliferation potential, capacity to home to inflammatory sites, anti-inflammatory,
anti-fibrotic and immunomodulatory properties. If all MSC share several characteristics
regardless of the tissue source, the highest productions of bioactive molecules and the
strongest immunomodulatory properties are yielded by those from the Wharton's jelly of the
umbilical cord. An additional advantage is that they can be scaled-up to generate banks of
cryofrozen and thus readily available products. These cells have already been tested in
several clinical trials with an excellent safety record.
The objective of this project is to treat intubated-ventilated patients presenting with a
SARS-CoV2-related Acute Respiratory Distress Syndrome (ARDS) of less than 96 hours by three
intravenous infusions of umbilical cord Wharton's jelly-derived mesenchymal stromal cells
(UC-MSC) one every other day (duration of the treatment: one week). The primary endpoint is
the PaO2/FiO2 ratio at day 7. The evolution of several inflammatory markers, T regulatory
lymphocytes and donor-specific antibodies will also be monitored. The trial will include 60
patients, of whom 20 will be cell-treated while the remaining 40 patients will be injected
with a placebo solution in addition to the standard of care. Given the pathophysiology of
SARS-CoV2, it is thus sound to hypothesize that the intravenous administration of UC-MSC
during the initial phase of ARDS could control inflammation, accelerate its recovery with
improved oxygenation, reduced mechanical ventilation and ventilation weaning time and
therefore reduced length of stay in intensive care.
The feasibility of the project is supported by the expertise of the Méary Cell and Gene
Therapy Center, which is approved for the production of Advanced Therapy Medicinal Products
and has already successfully prepared the first batches of cells, as well as by the
involvement of a cardiac surgery team which will leverage its experience with stem cells for
the treatment of heart failure to make it relevant to the Stroma-Cov-2 project.
Primary Outcomes
Measure: Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group Time: From baseline to day 7
Secondary Outcomes
Measure: Lung injury score Time: From baseline to day 28
Measure: Oxygenation index Time: From baseline to day 28
Measure: In-hospital mortality Time: From baseline to day 28
Measure: Mortality Time: At day 28
Measure: Ventilator-free days Time: From baseline to day 28
Measure: Number of days between randomization and the first day the patient meets weaning criteria o Number of days between randomization and the first day the patient meets PaO2/FiO2 > 200 (out of a prone positioning session) Time: From baseline to day 28
Measure: Cumulative use of sedatives Time: From baseline to day 28
Measure: Cumulative duration of use of sedatives Time: From baseline to day 28
Measure: Cumulative duration of use of neuromuscular blocking agents (other than used for intubation) Time: From baseline to day 28
Measure: Cumulative use of neuromuscular blocking agents (other than used for intubation) Time: From baseline to day 28
Measure: ICU-acquired weakness and delirium Time: From baseline to day 28
Measure: Treatment-induced toxicity rate and adverse events up to day 28 Time: From baseline to day 28
Measure: Quality of life at one year (EQ5D-3L quality of life questionnaire) Time: At 6 months and 12 months
Measure: Measurements of plasmatic cytokines (IL1, IL6, IL8, TNF-alpha, IL10, TGF-beta, sRAGE, Ang2) level Time: At day 1, 3, 5, 7 and 14
Measure: Anti-HLA antibodies plasmatic dosage Time: From baseline to day 14, and at 6 months
No related HPO nodes (Using clinical trials)