Open Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC) (THALASSA)

[EndME]

Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC) (THALASSA)

Brief Summary
The study aims to prove that plitidepsin could be an efficacious, safe, and well-tolerated therapy for PCC. To this end, we will perform a randomized, double-blind study comparing the clinical and laboratory benefits of plitidepsin vs. placebo in 90 subjects with moderate to severe functional disability. The study consists of an intervention period and a follow-up period, with a total of 135 +/-3 days approximately between both periods.

During the intervention period, four treatment cycles will be administered, scheduled every 15 days (every 2 weeks), with intravenous (IV) infusion over three consecutive days. After completing the intervention period, a 90-day (+/-5) follow-up period will be conducted.

Subjects in arm A will receive the plitidepsin 1.5 mg/day 1h-IV during the four treatment periods on Days 1 to 3, Days 15 to 17, Days 29 to 31 and Days 43 to 45. Subjects in arm B will receive 1h-IV placebo 1 vial /day during the first two treatment periods and will receive the plitidepsin 1.5 mg/day 1h-IV during the last two treatment periods. Subjects in arm C will receive 1h-IV placebo 1 vial/day during the four treatment periods.

https://clinicaltrials.gov/study/NCT06766825?cond=long covid&sort=StudyFirstPostDate&rank=6

 

[Jonathan Edwards]

This seems to be an obscure cell poison derived from sea-squirts. It might be useful in cancer.
Not sure I would want to try it for Long Covid.

 

[Utsikt]

This seems to be an obscure cell poison derived from sea-squirts. It might be useful in cancer.
Not sure I would want to try it for Long Covid.

Their reasoning:
Plitidepsin, a marine-derived cyclic depsipeptide that inhibits SARS-CoV-2 replication at nanomolar concentrations by targeting the host protein eukaryotic translation elongation factor 1A, could be a suitable candidate treatment for "Long COVID" because of a triple mechanism of action; a) it has demonstrated potent anti-SARS-CoV-2 in vitro activity, (b) it has a systemic anti-inflammatory effect, detailed in the text below, and (c) has an anti-herpes antiviral effect, which could provide additional therapeutic benefits to prevent herpesvirus reactivation seen in Long-COVID.

 

[Jonathan Edwards]

As poisons tend to!

 

[Utsikt]

As poisons tend to!

I can understand the anti-viral effect of poison, but what about the anit-inflammatory effect? Is that normal? My completely uneducated intuition is that poison is inflammatory.