|drug2542||Plasma from COVID-19 convalescent patient Wiki||0.71|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.06|
|D055371||Acute Lung Injury NIH||0.06|
There are 2 clinical trials
As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal failure. No specific pharmacological treatment is available yet. The lung lesions are related to both the viral infection and to an intense inflammatory reaction. Because of it's action, as an immunomodulatory agent that can attenuate the inflammatory reaction and also strengthen the antiviral response, it is proposed to evaluate the effectiveness and safety of intravenous immunoglobulin administration (IGIV) in patients developing ARDS post-SARS-CoV2. IGIV modulates immunity, and this effect results in a decrease of pro-inflammatory activity, key factor in the ARDS related to the COVID-19. It should be noted that IGIV is part of the treatments in various diseases such as autoimmune and inflammatory diffuse interstitial lung diseases. In addition, they have been beneficial in the post-influenza ARDS but also have been in 3 cases of post-SARS-CoV2 ARDS. IGIV is a treatment option because it is well tolerated, especially concerning the kidney. These elements encourage a placebo-controlled trial testing the benefit of IGIV in ARDS post-SARS-CoV2.
Description: Sum of the days the patient did not receive VM, but if death occurs before D28, the score is zeroMeasure: Ventilator-free days Time: 28 days
Description: Vital status at 28 and 90 daysMeasure: Mortality Time: 28 and 90 days
Description: Used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing the higher the scoreMeasure: Sequential Organ Failure Assessment Score Time: Days 1, 3, 7, 14, 21 and 28
Description: Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)Measure: P/F ratio Time: Days 1, 3, 7, 14, 21 and 28
Description: Measure of lung complianceMeasure: Lung compliance Time: Days 1, 3, 7, 14, 21 and 28
Description: Severity scoring of lung oedema on the chest radiographMeasure: Radiological score Time: Days 1, 3, 7, 14, 21 and 28
Description: Concentration in mg/LMeasure: Biological efficacy endpoints - C-reactive protein Time: Days 1, 3, 7, 14, 21 and 28
Description: Concentration in microgram/LMeasure: Biological efficacy endpoints - Procalcitonin Time: Days 1, 3, 7, 14, 21 and 28
Description: Number of CD4 HLA-DR+ and CD38+, CD8 lymphocytesMeasure: Immunological profile Time: Up to 28 days
Description: Use of corticosteroids, antiretroviral, chloroquineMeasure: Number of patients using other treatments for COVID-19 related ARDS Time: Up to 28 days
Description: Diagnosis of deep vein thrombosis or pulmonary embolism through imaging exam (eg ultrasound and CT scan)Measure: Occurrence of deep vein thrombosis or pulmonary embolism Time: 28 days
Description: Total time of mechanical ventilation, weaning and use of neuromuscular blockadeMeasure: Total duration of mechanical ventilation, ventilatory weaning and curarisation Time: 28 days
Description: Divided in 3 stages, with higher severity of kidney injury in higher stagesMeasure: Kidney Disease: Improving Global Outcomes (KDIGO) score and need for dialysis Time: 28 days
Description: Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)Measure: Occurrence of adverse event related to immunoglobulins Time: 28 days
Description: Medical research council sum score on awakeningMeasure: Occurrence of critical illness neuromyopathy Time: Up to 28 days
Description: Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal samplingMeasure: Occurrence of ventilator-acquired pneumonia Time: Up to 28 days
Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives. Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection. Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin. Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.
Description: Mean days from admission as a suspected case of COVID with hospitalization criteria until dischargeMeasure: Mean hospitalization time Time: Through study completion, an average of 3 months
Description: Mean of delta of oxigenation index (PaO2/FiO2)Measure: Mean Oxigenation index evolution Time: Through study completion, an average of 3 months
Description: Rate of patients with evolution to severe ARDS (PaO2/FiO2 < 100)Measure: Rate of severe ARDS Time: Through study completion, an average of 3 months
Description: Rate of Dead caused by COVID-19 related complications and time to dead caused by COVID-19 complicationMeasure: Rate and time to dead Time: Through study completion, an average of 3 months
Description: Mean time with invasive mechanical ventilationMeasure: Mean time with invasive mechanical ventilation Time: Through study completion, an average of 3 months
Description: Time to negativization of RT-qPCR SARS-CoV-2 test.Measure: Time to Viral PCR Negativization Time: Through study completion, an average of 3 months.
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