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Standard of Care Only Group for Coronavirus

Phase 4

Waitlist Available

Led By Dominique L Musselman, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7

Awards & highlights

Study Summary

This trial is testing whether Valproate and Quetiapine can help to lower confusion and agitation in people with severe pneumonia caused by COVID-19, who are being weaned off of a ventilator.

Eligible Conditions

Coronavirus
Viral Pneumonia
Delirium

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline RASS score of +3 or greater

Secondary outcome measures

Incidence of Treatment Emergent Adverse Events

Total dose of dexmedetomidine administered

Trial Design

2Treatment groups

Active Control

Group I: Standard of Care Only GroupActive Control1 Intervention

Patients maintained with mechanical ventilation will be treated with standard of care after cessation of paralytic agents.

Group II: Treatment Arm GroupActive Control3 Interventions

Patients maintained with mechanical ventilation will be treated with standard of care, plus Valproate on Days 1-7 after cessation of paralytic agents, and then augmented by the addition of Quetiapine beginning Days 3-7 if there are no improvement in RASS score.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

899 Previous Clinical Trials

409,682 Total Patients Enrolled

Dominique L Musselman, MDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Treatment Arm Group generally employed?

"Treatment Arm Group is clinically proven to combat mental depression, as well as post traumatic stress disorder (ptsd), complex partial seizures, and Behcet syndrome."

Answered by AI

Is it currently feasible for individuals to enrol in this medical experiment?

"The data posted on clinicaltrials.gov reveals that this medical trial, which was initially made public February 1st 2023 is not actively accepting patients at the present moment. However, there are 1355 other trials in search of participants presently."

Answered by AI

What other experiments have been completed to analyze the efficacy of Treatment Arm Group?

"Currently, there are 31 clinical trials devoted to Treatment Arm Group. Of these studies, 6 have already reached the third stage of testing. While most of the research is being done in Miami, Florida, a total 544 locations across the globe are participating in this investigation."

Answered by AI

To what extent can the sample size of this investigation expand?

"Unfortunately, recruitment for this trial is currently on pause. It was initially posted in February of 2023 and last amended in October of 2022. If you're looking to join another clinical study, there are 1324 studies recruiting patients with pneumonia and 31 studies searching for participants to be part of a Treatment Arm Group."

Answered by AI

Has Treatment Arm Group been formally endorsed by the FDA?

"Treatment Arm Group is classified as a Phase 4 drug, signifying that it has been approved by regulatory bodies. Therefore, its safety rating received a score of 3 out of the possible maximum rating of 3."

Answered by AI