|drug214||Analogs, Prostaglandin E1 Wiki||0.58|
|drug3159||Standard therapeutic protocol Wiki||0.58|
|drug3205||Supportive Care Wiki||0.33|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.10|
|D055371||Acute Lung Injury NIH||0.10|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.09|
There are 3 clinical trials
This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs). Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells. The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Description: Treatment-related serious adverse events (tSAE) will be considered as those directly related to the investigational infusion product per protocol defined criteria.Measure: Treatment-related serious adverse events (tSAEs) Time: 28 days post cell infusion
Description: Change by at least two categories on a six category ordinal scale at day 14 post randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicates worse clinical outcomeMeasure: Change in clinical status at day 14 Time: 14 days post cell infusion
Novel coronavirus COVID-19 has become a health emergency around the world. Since first patients were detected in Wuhan China, in December 2019, COVID-19 has spread quickly worldwide, being a severe threat to public health. Fever, dry cough, shortness of breath and breathing distress are the main characteristics of COVID-19 infection. Some patients develop overwhelming lung inflammation and acute respiratory failure, for which there is no specific therapy. Therefore, safe and effective treatment for COVID-19 pneumonia is utterly necessary, mainly in critical cases. Mesenchymal stem cells (MSCs) have been widely used in the immune-mediated inflammatory diseases. MSCs can regulate both innate and adaptive immunity by suppressing the proliferation, differentiation and activation of different cells. These immunomodulatory properties of MSCs support performance of the phase I/II, placebo- controlled, randomized MSCs for treatment of severe COVID-19 pneumonia.
Description: Index of therapy success to preserve Intensive Care Hospitalization spaceMeasure: Proportion of patients who have achieved withdrawal of invasive mechanical ventilation Time: 0-7 days
Description: To measure global successMeasure: Rate of mortality Time: 28 days
Description: Index based in the 4 most relevant symptoms and signs: fever, shortness of bread, %Hemoglobin Saturation and PaO2 / FiO2Measure: Proportion of patients who have achieved clinical response Time: 0-7days
Description: Evaluation of pneumonia changesMeasure: Proportion of patients who have achieved radiological responses Time: 0-28 days
Description: Haemogram and cell subpopulationsMeasure: Blood white cell counts and their subpopulations. Time: 0-180 days
Description: Lymphocyte profiles, CD3, CD19, CD16+CD56, CD4/CD8, TregsMeasure: Cellular markers of inflammation Time: 0-180 days
Description: IL-10, IL-6, IP-10, TNF-alphaMeasure: Cytokines and chemokines in peripheral blood Time: 0-180 days
The clinical picture of the novel corona virus 2 (SARS-CoV-2) disease (COVID-19) is rapidly evolving. Although infections may be mild, up to 25% of all patients admitted to hospital require admission to the intensive care unit, and as many as 40% will progress to develop severe problems breathing due to the acute respiratory distress syndrome (ARDS). ARDS often requires mechanical ventilation, with a 50% risk of mortality. Researchers at the Ottawa Hospital Research Institute (OHRI) have been studying the potential therapeutic role of mesenchymal stromal/stem cells, or MSCs, for the treatment of ARDS for over a decade. This has led to the world's first clinical trial using MSC therapy for patients with severe infections (sepsis) which is often associated with ARDS (NCT02421484). This trial demonstrated tolerability, and potential signs of efficacy. In addition, the investigators have established expertise in producing clinical-grade MSCs and have received approval from Health Canada for the use of MSCs in three different clinical studies. The investigators propose a Phase 1, open label, dose-escalating and safety trial using a 3+3+3 design to determine the safety, and maximum feasible tolerated dose of repeated delivery of Bone Marrow (BM)-MSCs intravenously. This will take advantage of a limited supply of screened BM-MSCs lines which are available now in the GMP facility and will allow to have product ready to deliver to the first patient within weeks. The investigators will enroll up to 9 patients; each receiving repeated unit doses of BM-MSCs delivered by IV infusion on each of 3 consecutive days (24±4 hours apart) according to the following dose-escalation schedule (3 patients per dose panel): (i) Panel 1: 25 million cells/unit dose (cumulative dose: 75 million MSCs), (ii) Panel 2: 50 million cells/unit dose (cumulative dose: 150 million MSCs), (iii) Panel 3: up to 90 million cells/unit dose (cumulative dose: up to 270 million MSCs).
Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 to determine the maximum feasible tolerated dose (MFTD) of BM-MSCs given to patients with COVID-19Measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Time: At time of infusion until one year post-infusion
Description: Number of Participants alive by Day 28Measure: Number of Participants alive by Day 28 Time: Day 28
Description: Number of Participants with ventilator-free Days by Day 28Measure: Number of Participants with ventilator-free Days by Day 28 Time: Day 28
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports