drugset / Trial / NCT04513314

Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

NCT04513314

Phase 4 Withdrawn University of Miami
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.

Timeline

Start
2023-03-28
Primary completion
2023-03-28
Completion
2023-03-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Quetiapine Small molecule 150 mg Other
Comparator Quetiapine Small molecule 750 mg Other
Comparator Valproate Small molecule 10 mg/kg Intravenous
Comparator Valproate Small molecule 15 mg/kg Intravenous