Name (Synonyms) | Correlation | |
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drug659 | Convalescent plasma (CP) Wiki | 1.00 |
drug2314 | Standard care Wiki | 0.38 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
Description: Death of the patient (yes/no)
Measure: Mortality Time: Up to 30 days after the study enrollmentDescription: Presence of any of the following adverse events (yes/no): Nonhemolytic febrile reactions Allergic reactions Acute hemolytic reactions Non-immune hemolysis Acute transfusion-related lung damage Transfusion-related circulatory overload Metabolic reactions Hypotensive reactions Delayed hemolytic reactions Post transfusion purple Graft versus host disease Bacterial contamination of blood components Viral infections Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
Measure: Adverse events Time: Up to 30 days after the study enrollmentDescription: Admitted to intensive care units (ICUs) (yes/no)
Measure: ICU admission Time: Up to 30 days after the study enrollmentDescription: Mechanical ventilation requirement (yes/no)
Measure: Mechanical ventilation Time: Up to 30 days after the study enrollmentDescription: Intensive care unit length of stay
Measure: ICU length Time: Up to 30 days after the study enrollmentDescription: D dimer reduction below 1mcg / ml
Measure: Reduction of D Dimer Time: Assessment at day 30 after study enrollmentDescription: Reduction of LDH below 350 IU / L
Measure: LDH reduction Time: Assessment at day 30 after study enrollmentDescription: Reduction of troponin level to than 8 pg / mL
Measure: Reduction of Troponin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in ferritin level below 1025 mcg / L
Measure: Decrease in ferritin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in procalcitonin level below 0.1ng / ml
Measure: Decrease in procalcitonin level Time: Assessment at day 30 after study enrollmentDescription: Decrease in CRP level bellow <8 mg / L
Measure: Decrease in CRP Time: Assessment at day 30 after study enrollmentDescription: Increase in lymphocyte count greater than 0.6 x 10-9 / L
Measure: Increase in lymphocyte count Time: Assessment at day 30 after study enrollmentDescription: Increase in PaO2 / Fio2 greater than 200
Measure: Increase in PaO2 / Fio2 Time: Assessment at day 30 after study enrollmentDescription: Scale of 24 points, greater number indicates worst outcome
Measure: Decrease in Sequential Organ failure assessment (SOFA ) score Time: Assessment at day 30 after study enrollmentDescription: Extracorporeal membrane oxygenation requirement (ECMO)
Measure: Extracorporeal membrane oxygenation (ECMO) Time: Assessment at day 30 after study enrollmentDescription: Decrease in the percentage of lung infiltration
Measure: Lung infiltration Time: Assessment at day 30 after study enrollment