Status:
WITHDRAWN
Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium
Lead Sponsor:
University of Miami
Conditions:
Covid19
Hyperactive Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 p...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form by his or her legal/authorized representative
- Age ≥ 18 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgement
- Hospitalized with COVID-19 pneumonia confirmed with World Health Organization (WHO) criteria (including an RNA test of any specimen, e.g. respiratory, blood, urine, stool, other bodily fluid) and evidence by chest X-ray or CT scan
- Fraction of inspired oxygen (Fi02) ≤ 0.40 and positive end-expiratory pressure (PEEP) ≤8 OR Fi02 ≤ 0.50 and PEEP ≤5
- Fi02 and PEEP ≤ values of previous day
- Patient has acceptable spontaneous breathing efforts (may decrease vent rate by 50% for 5 minutes to detect effort.)
- No neuromuscular blocking agents or blockade.
- RASS score initially at -3 ≤, rising to 3+ after initial attempt to wean from standard of care sedating medications
- Other investigational interventions may be permitted
Exclusion
- Known severe allergic reactions to valproate or quetiapine
- History of hepatic encephalopathy or end-stage liver disease (Childs-Pugh class B or worse)
- Alcohol, or history of alcohol/substance dependence prior to admission
- Hx of dementia
- Treatment with an antipsychotic agent in the 30 days before ICU admission
- Baseline QT duration corrected (QTc) interval ≥ 500 msecs
- Pregnancy
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 X upper limit of normal (ULN) detected within 24 hours at screening or at baseline
- Absolute neutrophil count (ANC) \< 1000/microliter (uL) at screening and baseline
- Platelet count \< 50,000/uL at screening and baseline
- Individuals \< 18 (infants, children, teenagers)
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgement, precludes the patient's safe participation in and completion of the study, e.g. active seizure disorder already receiving treatment with lamotrigine
- Informed consent could not be obtained from the legally authorized representative.
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04513314
Start Date
March 28 2023
End Date
March 28 2023
Last Update
March 31 2023
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