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There is one clinical trial.
An effective, widely available, and safe treatment that can decrease the duration, severity and fatality of COVID-19 is urgently needed. Also, in the most affected regions the pressure on health care systems including ventilator support capacity can be a limiting factor for survival. Initial studies including from our group indicate that administering convalescent plasma containing high titers of neutralizing antibodies to COVID-19 patients who are already relatively late during the disease course after hospital admission is not effective, which can be explained by high titers of autologous antibodies present in patients. Thus, the antiviral capacity of convalescent plasma is hypothesized to be best positioned early in the disease course and in patients at increased risk for a severe disease course. If effective, any treatment that decreases the need for hospital admission is very valuable but so far, no COVID-19 treatment has been shown to prevent clinical deterioration when given before patients are admitted to the hospital. Primary objective: To evaluate the efficacy, feasibility and safety following the administration of convalescent plasma (ConvP) as a therapy for outpatients diagnosed with COVID-19 at increased risk for an unfavourable clinical outcome and within 7 days after symptom onset. Study design: This trial is a nationwide multicenter, double blind, randomized controlled trial in the Netherlands. Patients will be randomized between the transfusion of 300mL of convP versus regular fresh frozen plasma (FFP). Patient population: Patients with polymerase chain reaction (PCR) confirmed COVID disease with less than 8 days of symptoms, age 70 or older or 50-69 years with at least 1 additional risk factor for severe COVID-19 are eligible. Intervention: 300mL of convP with a minimum level of neutralizing antibodies. A total of 690 patients will be included. Expected duration of accrual: 18-24 months Duration of follow up :Day 28 for the primary endpoint
Description: Highest disease status on the 5-point ordinal disease severity scale in the convP group will be compared with the FFP group.Measure: Highest disease status Time: 28 days following transfusion of convP or FFP
Description: Percentage of deaths in the convP group compared to the FFP groupMeasure: Percentage of deaths Time: 28 days following transfusion of convP or FFP
Description: Percentage of hospital admissions in the convP group compared to the FFP groupMeasure: Percentage of hospital admissions Time: 28 days following transfusion of convP or FFP
Description: Percentage of ICU admissions in the convP group compared to the FFP groupMeasure: Percentage of ICU admissions Time: 28 days following transfusion of convP or FFP
Description: Disease duration in days of symptoms in the convP group compared to the FFP groupMeasure: Disease duration in days of symptoms Time: 28 days following transfusion of convP or FFP
Description: Age and clinical frailty score stratified analysis of percentage of primary endpoint following transfusion of convP versus FFP.Measure: Age and clinical frailty score Time: 28 days following transfusion of convP or FFP
Description: Analysis of primary endpoint following transfusion of convP versus FFP stratified by the presence of neutralizing antibodies at baseline and by symptom duration at baseline.Measure: Highest disease status stratified by presence of neutralizing antibodies and by symptom duration at baseline Time: 28 days following transfusion of convP or FFP
Description: Change in proportion of detectable SARS-CoV-2 RT-PCR results at day 3, 7, 14 and 28 following transfusion according to the presence of neutralizing antibodies at baselineMeasure: Change in proportion of detectable SARS-Cov-2 RT-PCR results Time: Day 3, 7, 14 and 28 following transfusion of convP or FFP
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