Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19

"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."