CovidResearchTrials by Shray Alag


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Plitidepsin 1.5 mg/dayWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug1873 Plitidepsin 2.5 mg/day Wiki 1.00
drug1872 Plitidepsin 2.0 mg/day Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Multicenter, Randomized, Parallel and Proof of Concept Study to Evaluate the Safety Profile of Three Doses of Plitidepsin in Patients With COVID-19 Requiring Hospitalization

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.

NCT04382066 COVID-19 Drug: Plitidepsin 1.5 mg/day Drug: Plitidepsin 2.0 mg/day Drug: Plitidepsin 2.5 mg/day

Primary Outcomes

Description: Percentage of patients with Neutropenia ≥ grade 3

Measure: Frequency of occurrence of Neutropenia ≥ grade 3

Time: Up to 31 days

Description: Percentage of patients with Thrombocytopenia ≥ grade 3

Measure: Frequency of occurrence of Thrombocytopenia ≥ grade 3

Time: Up to 31 days

Description: Percentage of patients with Anemia ≥ grade 3

Measure: Frequency of occurrence of Anemia ≥ grade 3

Time: Up to 31 days

Description: Percentage of patients with Lymphopenia ≥ grade 3

Measure: Frequency of occurrence of Lymphopenia ≥ grade 3

Time: Up to 31 days

Description: Percentage of patients with CPK increase ≥ grade 3

Measure: Frequency of occurrence of CPK increase ≥ grade 3

Time: Up to 31 days

Description: 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 days

Description: 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 days

Description: Percentage of patients with Neurotoxicity ≥ grade 3

Measure: Frequency of occurrence of Neurotoxicity ≥ grade 3

Time: Up to 31 days

Description: 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 days

Description: Percentage of patients with Other adverse events ≥ grade 3

Measure: Frequency of occurrence of Other adverse events ≥ grade 3

Time: Up to 31 days

Description: 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 treatment

Description: Percentage of patients with adverse events.

Measure: Percentage of patients with adverse events.

Time: Up to 31 days

Description: Percentage of patients with serious adverse events.

Measure: Percentage of patients with serious adverse events.

Time: Up to 31 days

Description: Percentage of patients with ECG abnormalities.

Measure: Percentage of patients with ECG abnormalities.

Time: Up to 31 days

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: Percentage of patients who die during the study

Measure: Mortality

Time: Up to 31 days

Description: 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 days

Description: Percentage of patients requiring non-invasive mechanical ventilation

Measure: Percentage of patients requiring non-invasive mechanical ventilation

Time: Up to 31 days

Description: Percentage of patients requiring oxygen therapy

Measure: Percentage of patients requiring oxygen therapy

Time: Up to 31 days


No related HPO nodes (Using clinical trials)