|drug3192||Standard (specific) therapy for COVID-19 Wiki||0.45|
|drug3202||Standard Of Care (SOC) Wiki||0.45|
|D001342||Autonomic Nervous System Diseases NIH||0.45|
|D054969||Primary Dysautonomias NIH||0.45|
|D018352||Coronavirus Infections NIH||0.07|
There are 5 clinical trials
This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.
Description: DaysMeasure: Median duration of fever Time: 1 year
Description: DaysMeasure: Median duration of mechanical ventilation Time: 1 year follow up
Description: DaysMeasure: Median length of ICU stay Time: 1 year follow up
Description: DaysMeasure: Median length of admission Time: 1 year follow up
Description: daysMeasure: Median length of viral clearance Time: 1 year follow up
A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.
Description: Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.Measure: Admission to ICU and/or mechanical ventilation Time: One year
Description: Time in the hospital from admission to discharge or death.Measure: Length of hospital stay Time: One year
Description: Neutralizing antibody (IgG) titers against COVID-19Measure: Neutralizing antibody (IgG) titers against COVID-19 Time: One year
Description: Non-serious adverse events (NSAEs) and serious adverse events (SAEs)Measure: Safety - Adverse events Time: One year
Description: Overall mortalityMeasure: Death Time: One year
The goal of this study is to evaluate the safety and effectiveness of COVID-19 convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. - Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator - Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against SARS-CoV-2 and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubatedMeasure: Avoidance of intubation at 28 days (group A) Time: 28 days
Description: Count of group B participants (participants who are intubated at study entry) who dieMeasure: Mortality (group B) Time: 28 days
Description: Count of participants who experienced cardio-circulatory arrestMeasure: Cardio-circulatory arrest Time: 28 days
Description: Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcomeMeasure: Patient Outcome at 28 days Time: 28 days
Description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.Measure: Renal failure Time: 28 days
Description: Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%Measure: Liver failure Time: 28 days
Description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)Measure: Cytokine Storm Time: 28 days
Description: Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation .Measure: Respiratory support Time: 28 days
Description: Count of participants who received pressor drugs, as ordered by treating physiciansMeasure: Vasopressor medication support Time: 28 days
Description: Length of ICU stay in days, for participants who entered ICUMeasure: Length of ICU length of stay Time: 28 days
Description: Count of patients admitted to the ICU who die in ICUMeasure: Intensive Care Unit (ICU) mortality Time: 28 days
Description: Length of hospital stay in daysMeasure: Hospital length of stay Time: 28 days
Description: Number of ventilator-free hospitalized daysMeasure: Ventilator free days Time: 28 days
Description: Length of intubation, measured in daysMeasure: Intubation duration Time: 28 days
Description: Count of participants readmitted to hospital following index procedure hospital dischargeMeasure: Readmission Time: 90 days
Description: Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.Measure: Serum anti-SARS-CoV-2 IgG Time: During hospitalization, a maximum of 28 days
Description: Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.Measure: SARS-CoV-2 RNA Time: During hospitalization, a maximum of 28 days
Description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who dieMeasure: Mortality (group A) Time: 28 days
Description: Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)Measure: Time from Transfusion to end of ventilator support (group B) Time: During hospitalization, a maximum of 28 days
The purpose of this study is to identify early signals of efficacy or harm associated with convalescent plasma therapy in a population of Veteran inpatients with coronavirus disease 2019 (COVID-19).
Description: Death at any time after admission recorded in the electronic health record. Specific estimates of risk of death will be produced for 7 days, 14 days, 21 days and 28 days, and total deaths.Measure: All-cause mortality Time: up to 28 days
Description: Number of days from index date to first intubation in non-mechanically ventilated patientsMeasure: Time to first intubation Time: 28 days
Description: Number of days from index date to hospital dischargeMeasure: Time to hospital discharge Time: 28 days
Description: Number of days from index date to death from any causeMeasure: Time to all-cause mortality Time: 28 days
Description: Long-term outcomes will include death at one year following the index date.Measure: All-cause mortality Time: 1 year
Data processed on September 26, 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