Name (Synonyms) | Correlation | |
---|---|---|
drug1873 | Plitidepsin 2.5 mg/day Wiki | 1.00 |
drug1872 | Plitidepsin 2.0 mg/day Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the ready availability of plitidepsin as a potential antiviral agent, based on pre-clinical studies, this randomized, parallel and proof of concept trial will evaluate the safety of three doses of plitidepsin in patients hospitalized with COVID-19.
Description: Percentage of patients with Neutropenia ≥ grade 3
Measure: Frequency of occurrence of Neutropenia ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Thrombocytopenia ≥ grade 3
Measure: Frequency of occurrence of Thrombocytopenia ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Anemia ≥ grade 3
Measure: Frequency of occurrence of Anemia ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Lymphopenia ≥ grade 3
Measure: Frequency of occurrence of Lymphopenia ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with CPK increase ≥ grade 3
Measure: Frequency of occurrence of CPK increase ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Increase ALT and / or AST ≥ grade 3
Measure: Frequency of occurrence of Increase ALT and / or AST ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Increase total bilirubin or direct bilirubin ≥ grade 3
Measure: Frequency of occurrence of Increase total bilirubin or direct bilirubin ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Neurotoxicity ≥ grade 3
Measure: Frequency of occurrence of Neurotoxicity ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with QT-QTc interval extension ≥ grade 3
Measure: Frequency of occurrence of QT-QTc interval extension ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients with Other adverse events ≥ grade 3
Measure: Frequency of occurrence of Other adverse events ≥ grade 3 Time: Up to 31 daysDescription: Percentage of patients in whom treatment cannot be completed and the reasons.
Measure: Percentage of patients in whom treatment cannot be completed. Time: At 3 days from the first dose of study treatmentDescription: Percentage of patients with adverse events.
Measure: Percentage of patients with adverse events. Time: Up to 31 daysDescription: Percentage of patients with serious adverse events.
Measure: Percentage of patients with serious adverse events. Time: Up to 31 daysDescription: Percentage of patients with ECG abnormalities.
Measure: Percentage of patients with ECG abnormalities. Time: Up to 31 daysDescription: Percentage of change in the viral load of SARS-CoV-2 from baseline.
Measure: Change in the viral load of SARS-CoV-2 Time: Up to 31 daysDescription: Time from inclusion/randomization to date of negative PCR test for COVID-19
Measure: Time to negative PCR test for COVID-19 Time: Up to 31 daysDescription: Percentage of patients who die during the study
Measure: Mortality Time: Up to 31 daysDescription: Percentage of patients requiring invasive mechanical ventilation and / or ICU admission
Measure: Percentage of patients requiring invasive mechanical ventilation and / or ICU admission Time: Up to 31 daysDescription: Percentage of patients requiring non-invasive mechanical ventilation
Measure: Percentage of patients requiring non-invasive mechanical ventilation Time: Up to 31 daysDescription: Percentage of patients requiring oxygen therapy
Measure: Percentage of patients requiring oxygen therapy Time: Up to 31 days