There is one clinical trial.
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patient lead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for a total of 40 patients) to assess efficacy of decitabine in the treatment of critically ill patients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receive standard of care plus Decitabine or standard of care plus saline based placebo. The primary objective is to determine safety and efficacy of decitabine for COVID-19 ARDS based on clinical improvement on a 6-point clinical scale.
Description: Clinical improvement within 10 days since start of treatment, defined as a decrease of at least 1 point within 10 days from baseline on a six-point ordinal scale: Not hospitalized/discharged; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; Hospitalized, requiring invasive mechanical ventilation, extra-corporeal membrane oxygenation (ECMO), or both; and Death.Measure: Change in clinical state as assessed by a 6-point ordinal scale Time: Baseline and daily up to day 10
Description: Safety assessments using adverse events will be monitored daily while inpatient and weekly through end of study at week 6 once discharged from hospital. They will be monitored and graded using Common Terminology Criteria Adverse Events version 5.0.Measure: Safety as assessed by adverse events Time: Up to 6 weeks
Description: Oxygenation index is used to assess severity of hypoxic respiratory failure. (OI = mean airway pressure (MAP) × Fraction of inspired oxygen (FiO2) × 100÷ partial pressure of oxygen (PaO2). This will be measured daily while subject is on mechanical ventilation up to 6 weeks.Measure: Change in oxygenation index Time: Daily, up to 6 weeks
Description: Fraction of inspired oxygen in the oxygen delivery system during hospital stay. Measured at 8 am daily during hospital stay and then weekly until day 29.Measure: Change in fraction of inspired oxygen Time: Up to day 29
Description: Number of days for subject that have a reduction by at least 2 point from baseline on a six point ordinal scale: Not hospitalized/discharged; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; Hospitalized, requiring invasive mechanical ventilation, extra-corporeal membrane oxygenation (ECMO), or both; and Death.Measure: Time (days) to clinical improvement Time: Up to 6 weeks
Description: Patients status of alive versus death at completion of study follow up period, i.e. 6 weeks from start.Measure: Overall survival Time: Up to 6 weeks
Description: Duration of days from baseline to hospital discharge.Measure: Length of stay in hospital Time: Till hospital discharge, up to 6 weeks
Description: For subjects who received mechanical ventilation, total number of days from baseline to end of study at 6 weeks that subject was not on mechanical or non invasive mechanical ventilation.Measure: Ventilator free days Time: Up to 6 weeks
Description: If viremic at starting date of decitabine - time from baseline to 1st recorded negative COVID nucleic acid amplification (NAT) based assay, measured in days.Measure: Time to Polymerase chain reaction (PCR) negativity Time: Up to 6 weeks
Description: Determines the degree of illness of a patient and prompts critical care intervention. This composite score includes Respiratory Rate, Temperature, oxygen Saturation, Blood Pressure, Oxygen inspired and cognitive status. This will be measured at baseline and weekly while patient is in hospital.Measure: Percentage of patients with National Early Warning Score 2 of 3 or more Time: Weekly while patient is in hospital, up to 6 weeks
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