A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium

Ketamine

Brief 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.

Intervention / Treatment

  • Drug: Valproate
  • Drug: Quetiapine
  • Other: Standard of Care

Condition or Disease

  • Covid19
  • Hyperactive Delirium
  • Pneumonia, Viral

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 20 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Sep 01, 2020
Primary Completion: Sep 01, 2021
Completion Date: Sep 01, 2021
Study First Posted: Aug 14, 2020
Results First Posted: Aug 31, 2020
Last Updated: Aug 14, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Miami, Florida, USA

This is a pilot feasibility study involving a randomized, single-blind, controlled comparison scheme examining the efficacy and safety of standard of care (n=10) combined with valproate alone, and in combination with quetiapine (N=10) , in order to reduce the magnitude of agitation associated with COVID 19 delirium as assessed by the RASS scale when weaning from a ventilator, and reduce need for dexmedetomidine as assessed by number of doses of dexmedetomidine administered.

Eligibility Criteria

Sex: All
Minimum Age: 18

More Details

NCT Number: NCT04513314
Other IDs: 20200851
Study URL: https://ClinicalTrials.gov/show/NCT04513314
Last updated: Jan 27, 2021