COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04513314

Dominique L Musselman

Not reported

2020-08-14

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Treatment

inclusion criteria: - 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

- 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.

2

University of Miami

18

100

None

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

Change from baseline RASS score of +3 or greater

None

Phase 4

[{"arm_notes": "", "treatment_id": 2260, "treatment_name": "Quetiapine+valproate", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]