At a glance
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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 Brief
A Phase 1 clinical trial evaluating Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day, and 1 other intervention for COVID-19. Completed, enrolled 46 participants across 13 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.
Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.
Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days. All patients must receive the following prophylactic medications 20-30 minutes before the infusion of plitidepsin: * Diphenhydramine hydrochloride 25 mg iv or equivalent. * Ranitidine 50 mg iv or equivalent. * Dexamethasone 8 mg iv. * Ondansetron 8 mg i.v. 15 minutes infusion or equivalent. * Ondansetron 4 mg p.o. administered every 12 hours until 48 hours after the last administration of plitidepsin.