|drug2513||Placebo Atrovastatin Wiki||0.71|
|drug3919||lung ultrasound (LUS) Wiki||0.71|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.06|
|D055371||Acute Lung Injury NIH||0.06|
There are 2 clinical trials
This clinical trial will enroll participants that have pneumonia caused by the COVID-19 virus. During the study patients will receive 7 to up to 14 days of defibrotide. After completing the treatment, participants will have 30 day follow-up check-up to assess for adverse events and clinical status. This final assessment can be done virtually, by telephone or electronically (email) if the patient cannot be contacted by phone. No in-person visit is required. The hypothesis of this trial is that defibrotide therapy given to patients with severe SARS-CoV2 ARDS will be safe and associated with improved overall survival, within 28 days of therapy initiation.
Description: Major hemorrhagic complications will be based on the International Society on Thrombosis and Haemostasis Bleeding scale. Fatal Bleeding, and/or Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or Bleeding associated with a decline in hemoglobin level of > 2.0 g/dl, leading to transfusion of two or more units of whole blood or red cells. In addition, symptomatic alveolar hemorrhage, macroscopic hematuria, uncontrolled menorrhagia or epistaxis or bleeding from any wound site would also be considered a major hemorrhagic event.Measure: Number of major hemorrhagic complications within 14 days of initiation of treatment Time: 14 days
Description: Proportion of the twelve patients who are alive at day 28 after starting treatment.Measure: Overall survival Time: 28 days
Description: Proportion of the twelve patients who are alive at Day 14 after starting treatment.Measure: Overall survival Time: 14 days
Description: Day 14 ventilator-free survival will be summarized by the proportion of the twelve patients who are both alive and not using a ventilator at Day 14 after starting treatment.Measure: Ventilator free survival Time: 14 days
Description: Improvement in oxygenation defined as an increase in atio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) of 50 (or greater) compared to the nadir of PaO2/FiO2.Measure: The time to improvement in oxygenation Time: up to 14 days
Description: Ordinal scale: Ambulatory (1) - No limitation of activities (2) - Limitations of activities Hospitalized: (3) no oxygen therapy (4) oxygen by mask or nasal prongs Hospitalized: (5) Non-invasive ventilation or high-flow oxygen (6) Intubation and mechanical ventilation (7) Mechanical ventilation plus additional organs support-pressors, renal replacement therapy (RRT), Extracorporeal membrane oxygenation (ECMO) Dead: (8) DeathMeasure: Mean change in the WHO COVID-19 Ordinal Scale during therapy Time: up to 14 days
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
Description: The rate of adverse event of special interest (bleeding and hypotension)Measure: The rate of adverse event of special interest (bleeding and hypotension) Time: Up to 21 days
Data processed on January 01, 2021.
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