Clinical trial NCT04578886
Conditions: Delirium
Keywords: Delirium Critically Ill Guanfacine
Sponsor: University of Alabama at Birmingham
Start date: 2020-11-23; Completion date: 2023-04-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Delirium in patients in the intensive care unit (ICU) is a common problem associated with increased mortality and morbidity, including increased hospital and ICU length of stay, greater hospital cost, increased ventilator days, and long-term cognitive disability. Various pharmacologic agents including dopamine antagonists, acetylcholinesterase inhibitors, melatonin, antipsychotics, alpha-2 agonists, and glutamate antagonists are used for treatment of delirium in the ICU despite the lack of clear evidence of efficacy.Since there is no evidence-based pharmacologic treatment of ICU delirium, current therapy is focused on non-pharmacologic prevention techniques and pharmacologic agents are used once delirium is established. Guanfacine, an alpha-2 agonist, has been identified as a potential medication that may be of benefit in the treatment of delirium. The purpose of this study to investigate the effects of guanfacine versus placebo on delirium in critically ill patients admitted to the ICU and to determine whether guanfacine along with standard of care reduces the duration of delirium, compared to standard of care alone.

Detailed description:
Delirium is a common problem in critically ill patients with a reported prevalence in the ICU ranging from 11% to 83%. Delirium has been associated with worse clinical outcomes including increased days on mechanical ventilation, length of hospital stay, cost of care, self-removal of important devices (endotracheal tubes, central venous catheters), use of physical restraint, long-term cognitive impairment, readmission, and mortality. The etiology of delirium is multifactorial, and risk factors include advanced age, substance abuse, metabolic derangements, and sleep disturbances.

Unfortunately, evidence-based strategies for treatment of ICU delirium do not exist. Even with the lack of strong evidence, both non-pharmacologic and pharmacologic therapies are used as standard care in clinical practice. Non-pharmacologic strategies considered as standard care include removal of causative factors, sleep maintenance, reorientation during the day, early mobilization activities, timely removal of catheters and physical restraints, and use of a scheduled pain management protocol. In combination with these non-pharmacologic strategies, ICU patients are treated with pharmacologic agents to render the patient safe and manageable and to promote sleep and normal circadian cycle. Despite lack of an FDA approved drug for treating delirium and clear-cut efficacy of any drug, various pharmacologic agents standardly used to treat delirium in the ICU include dopamine antagonists, acetylcholinesterase inhibitors, melatonin, antipsychotics, alpha-2 agonists, and glutamate antagonists. Antipsychotics, such as haloperidol, have been most commonly used. However, the effectiveness of routinely using antipsychotics in managing delirium has been questioned given the potential for adverse effects, medication interactions, and unproven benefit. Haloperidol can cause serious side effects including Q-T prolongation, sedation, and extrapyramidal symptoms. For this reason the use of haloperidol is less than ideal in the elderly patient population. Recent studies have looked at the perioperative use of dexmedetomidine in mechanically ventilated patients experiencing hyperactive delirium. Dexmedetomidine is a centrally-acting alpha 2 adrenergic receptor (α2-AR) agonist that generally quiets noradrenergic activity, producing sedative, analgesic and antihypertensive effects. When compared to haloperidol, patients receiving dexmedetomidine have fewer ventilation days, shorter ICU length of stay, less need for tracheostomy, and quicker resolution of delirium symptoms. Unfortunately, dexmedetomidine is expensive and delivered as an intravenous infusion.

Guanfacine, an alpha-2A antihypertensive agent with a safe pharmacodynamic profile, has also been reported as treatment of ICU delirium. It has found use as an adjunct therapy in the management of Attention Deficit Hyperactivity Disorder (ADHD). Compared to dexmedetomidine, guanfacine is a pure alpha-2A agonist with higher selectivity for the dorsolateral PFC structures leading to improved neuronal function by enhancing short-term memory. Noting a similarity between the inattention and hyperactivity of emergence and ADHD itself, clinicians have started using guanfacine to manage young, healthy males who were commonly at risk for emergence delirium after anesthesia. In this context, the drug has gained popularity for its off label use perioperatively in a wide variety of patients with anxiety issues, known or predicted to have potential for combative or difficult emergence.

Compared to dexmedetomidine, guanfacine may have a more unique and specific mechanism of behavior modification that could be beneficial as a treatment in delirium. Furthermore, oral guanfacine is cheaper and easier to use, with the ability to continue it outside the ICU. From a pharmacokinetic standpoint, guanfacine is absorbed with peak onset over 1-4 hour and has a half-life of 16 hours. The long half-life allows once-daily dosing before sleep. Maximal drug levels at night promote sleep, with some drug remaining during the day to provide a lesser degree of sedation. Outpatient studies have detected a ceiling effect on the antihypertensive effect of guanfacine, wherein doses of 1 mg, 2 mg, or 3 mg all have the same effect on blood pressure. This implies that up-titrating the guanfacine dose beyond 1 mg daily might increase sedative/hypnotic effects, without increasing hemodynamic instability. Maldonado et al at Stanford has utilized guanfacine for delirious/withdrawing patients (0.5-3 mg total daily dose). A recent case report by Dr. Habib Srour and colleagues described successful use of guanfacine (1 mg q12hr) to control refractory agitation in an ICU patient with a history of opioid misuse.

The investigators propose to perform a pilot trial to evaluate protocol adherence, estimate recruitment rates, and evaluate the safety and efficacy of guanfacine with standard care, compared to standard care alone, on delirium in ICU patients. Before testing other drugs compared with guanfacine, evidence needs to be collected to investigate if guanfacine is more effective than placebo in treating delirium in ICU patients. The control intervention is therefore chosen to be placebo along with standard or usual care. Given the literature and our own experience with the drug for ICU delirium, the investigators plan to use a dose of 2 mg nightly for efficacy and minimization of side effects. The investigators will withhold guanfacine or placebo if a patient does not have delirium for four consecutive assessments or for safety reasons. The investigators will permanently discontinue guanfacine or placebo for any life-threatening, serious adverse event that was related to the intervention. The trial drug or placebo will be discontinued after the 14-day intervention period or at ICU discharge, whichever occurs first.

Arms: arm 1: Placebo, lactulose monohydrate, encapsulated, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol. arm 2: Guanfacine immediate-release, 2mg dose, over-encapsulated tablet, once nightly at 2100, for up to 14 day study duration or otherwise indicated by study protocol.
Interventions: intervention 1: Guanfacine intervention 2: Placebo
Intervention descriptions: intervention 1: Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol. intervention 2: Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.

Protocol documents:
Prot_SAP_000.pdf: 
Title: The Effect of Guanfacine on Delirium in Critically Ill Patients  
Primary Investigator: Andrew B. Barker, MD  
University of Alabama at Birmingham 
Department of Anesthesiology and Perioperative Medicine, Division of Critical Care Medicine 
Contact: abbarker@uabmc.edu  
Phone: 205-934-6007 
Andrew Barker is a full-time faculty member of the University of Alabama at Birmingham’s Department 
of Anesthesiology and Perioperative Medicine and holds the academic standing of Associate Professor. 
Andrew has basic science research experience and maintains a strong interest in medical education and 
clinical research.  
NCT04578886 
Date Aug 18, 2019 
 


Location of Study: Research will be conducted at the University of Alabama at Birmingham Hospital 
and University of Alabama at Birmingham Highlands Hospital. Patients will be recruited in the UAB 
Surgical Intensive Care Units.  
Abstract 
Delirium has been identified as a significant problem in the intensive care unit that has been shown to 
lead to increased hospital and ICU length of stay, increased hospital cost, increased ventilator days, and 
long-term cognitive disability. The etiology of delirium is multifactorial, however, the elderly critically ill 
remain at highest risk. Therapy is largely targeted at nonpharmacologic prevention as promising 
treatments have not been standardized.  
One such pharmaceutical treatment is the medication dexmedetomidine. Originally designed as an 
antihypertensive, dexmedetomidine is a central acting alpha agonist used as a sedation adjunct and has 
shown to reduce the duration of delirium in the intensive care setting. Guanfacine, a medication with the 
same mechanism and within the same class as dexmedetomidine, has a more specific sight of action in the 
frontal lobe and therefore more behavior modification properties. For this reason, guanfacine has been 
shown to be an effective adjunct therapy in Attention Deficit Hyperactive Disorder and has a secondary 
FDA approval for its use in that behavior disorder.  
One of the hallmark symptoms of delirium is inattention and hyperactive behavior. Given the similarities 
between delirium and hyperactive disorders, guanfacine has been identified as a potential medication that 
may be of therapeutic benefit in the treatment of delirium. It is the purpose of this study to investigate the 
effects of guanfacine on delirium in critically ill patients admitted to the ICU.  
Null Hypothesis 
The administration of guanfacine in ICU patients with delirium will not reduce the duration of delirium. 
Hypothesis  
The administration of guanfacine in ICU patients with delirium will reduce the duration of delirium.  
Specific Aim  
To quantify the duration of delirium in ICU patients treated with guanfacine or placebo.  
Trial design  
The study will be a prospective, single center, randomized, placebo-controlled, double- blind, intervention 
trial of guanfacine 2 mg versus placebo in critically ill patients admitted to the ICU with an expected LOS 
of at least 72 hours. (two arms, 1:1 enrollment, parallel design).  
Methods  
Inclusion criteria  
• 
Patients admitted to the UAB hospital Surgical Intensive Care Unit (SICU) 
• 
18 years of age or older 


• 
Expected total ICU length of stay of 72 hours or more per treating physician 
• 
Diagnosed with delirium based on CAM-ICU assessment (see attached CAM-ICU assessment 
form) 
Exclusion Criteria  
• 
Patients younger than 18 years old 
• 
Expected discharge from ICU within 72 hours of admission 
• 
Expected or inevitable death with 48 hours of enrollment 
• 
Pregnancy or breast feeding 
• 
Non-English speaking 
• 
Patients unable to be assessed by CAM-ICU due to neurologic illness 
• 
Altered consciousness unable to participate in CAM-ICU assessment 
• 
Patients with previous diagnosis of chronic, acute, subacute neurologic disease, or 
neurodegenerative disease 
• 
Mental illness and/or psychosis 
• 
Acute alcohol withdrawal 
• 
No enteral route available for administration 
• 
Treating physician refusal of enrollment based on severe hypotension (defined as requiring a 
vasopressor for longer than 24 hours) or bradycardia (Hr<50 bpm) at the time of screening 
• 
Hepatic encephalopathy 
• 
Blind or Hearing impaired 
• 
Taking Guanfacine, for any reason 
• 
On CYP3A inhibitor such as azole antifungals or clarithromycin 
• 
On CYP3A inducers such as phenytoin or rifampin 
• 
Severe xerostomia 
• 
Enrolled in another interventional research trial 
Intervention  
-After patient or family member signs the informed consent 
-Patients are enrolled within 48 hours of being diagnosed with delirium 
-Randomization to placebo or study drug group on the day of enrollment  
-Placebo group will receive pharmaceutical placebo.  
-Guanfacine group will receive guanfacine 2 mg enterally via oral route or  
nasogastric tube at 21:00 for 14 consecutive nights or until ICU discharge.  
-CAM-ICU assessment will be conducted twice daily at am and pm. All data was deidentified and entered 
in secured RedCap database.  
Outcomes  
Primary  


Duration of delirium  
The primary outcome will be the number of days alive without delirium during the 14-day 
treatment period after randomization. Delirium assessments are measured by the Confusion 
Assessment Method- Intensive Care Unit (CAM-ICU). CAM-ICU measures a patient's 
fluctuations in mental status, inattention, disorganized thinking, and consciousness.  
All assessors using the CAM-ICU will receive training in the assessment tool along with 
monitoring to ensure the reliable implementation. The CAM-ICU will be used twice daily with all 
patients while admitted until ICU discharge. Patients will be diagnosed as delirious when they 
have at least one positive CAM-ICU on the day of assessment up to ICU discharge or day 14 after 
enrollment if remaining in ICU. Patients will be diagnosed as delirium free when they have four 
(4) negative consecutive CAM-ICU assessments. Assessors will be blinded to treatment group.  
Secondary  
1. Type of delirium or Coma 
Based on patient RASS score, the participants will be categorized as having either hyperactive 
delirium (RASS >+1) or hypoactive delirium (RASS -3 to 0), Mixed (both hyperactive and 
hypoactive for the observation period), or Coma (RASS </= -4.  
2. Duration of delirium 
Upon diagnosis of delirium, duration will be recorded as number of days of which the enrolled 
patient has a positive CAM-ICU until ICU discharge or day 14 after enrollment.  
3. Delirium Severity 
Assessors will administer the CAM-ICU-7 Delirium Severity assessment. 
Indirect markers of delirium severity will also be recorded daily until ICU discharge or day 14 
after enrollment. These markers are: 1) need for anti-psychotics or sedation (total daily doses will 
be calculated); 2) need for physical restraints; 3) patient removal of intravenous lines, drains or 
catheters.  
4. ICU and hospital LOS 
Length of stay will be recorded using existing hospital data programs.  
5. Morbidity and mortality 
Markers of morbidity and mortality will be recorded on a daily basis until ICU discharge or day 
14 after enrollment. These include: 1) duration of mechanical ventilation measured as ventilator 
free days; 2) daily need for vasopressor use; 3)daily need for renal replacement therapy; 4) 
reintubation, delayed extubation or need for tracheostomy; 5) SOFA scores; In addition we will 
record 6) mortality at 30 and 90 days; and 7) destination after ICU and hospital discharge.  
Analysis  
Statistical Analysis. Demographics, such as gender, race, and age, as well as clinical characteristics (such 
as type of surgery, comorbidities) will be summarized using descriptive statistics. Continuous variables 
will be summarized using sample mean and sample variance whereas categorical variables will be 
summarized as proportions. The test of efficacy will follow the rejection region approach detailed in the 
Sample Size section using a Type I error rate of 0.05. 95% confidence intervals will be used to describe 
the incidence of delirium within the study population. Logistic regression models will examine whether 
age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered.  
Projected Sample Size. The primary outcome for statistical evaluation is delirium free days, defined as the 
number of days out of a 14-day period following enrollment. Power analyses are based on this outcome. 


Based upon the historical evidence observed in the UAB Surgical ICU, delirium is experienced by 
approximately 24% of patients during their ICU stay.  
All sample size and power estimates below assume a two-group, parallel design with 1:1 allocation ratio. 
In Table 1, we treat the primary outcome as number of delirium-free days during each patient’s LOS.  
We consider a range of detectable differences and desired levels of power in Table 1 below. The analysis 
consists of a two-sample t-test assuming equal variances and evaluation at a 0.05 level of significance. A 
mean difference of 10% is considered clinically meaningful, with larger differences indicating greater 
benefit. However, we do not have preliminary data providing reference values for the average and 
standard deviation of delirium free days in the control population. Thus, we express our detectable 
differences in terms of standard deviations between the two groups.  
A sample size of 50 per group (100 total) will provide 85% power to detect an average proportion of 
delirium-free days in the treatment group that is at least 0.61 standard deviations different from the 
average proportion of delirium-free days in the control group.   
  
Table 1. Detectable Δ (standard deviation) with new sample size. 
 
Total(n) 
Power 
80% 
85% 
100 
0.57 
0.61 
90 
0.60 
0.64 
80 
0.63 
0.68 
 
 

ICF_001.pdf: 
Page 1 of 6
Version Date: 08/19/2020
CONSENT FORM
Title of Research:
The Effect of Guanfacine on Delirium in Critically Ill Patients
UAB IRB Protocol #:
IRB-300004839
Principal Investigator:
Andrew B. Barker, MD
Sponsor:
Department of Anesthesiology and Perioperative Medicine,
Division of Critical Care Medicine
General Information
You are being asked to take part in a research study. This research study is voluntary, 
meaning you do not have to take part in it. The procedures, risks, and benefits are fully 
described further in this consent form.
Purpose
The purpose of this study is to test how well the drug Guanfacine can help treat 
critically ill patients diagnosed with delirium in the Intensive Care Unit (ICU).
Duration & Visits
The study drug or placebo will be given up to 14 days or until discharge from the ICU.
Overview of Procedures
This is double blinded randomized controlled trial. This means that If you decide to 
take part in this study, a computer will assign you by chance to one of the study drugs. 
This is called randomization. You will either get the drug Guanfacine or a placebo. After 
you receive either, your doctor and study team will watch you for side effects as 
described below. Double blinded means neither you nor your doctor will know if you 
get the drug guanfacine or placebo. 
Risks
The medication used in this study, Guanfacine hydrochloride (Tenex), is a medication 
usually used to treat high blood pressure. You may experience some side effects from 
taking the study drug.
The side effects of Guanfacine are:

Slower heart rate

Lower blood pressure

Sleepiness

Dizziness

Dry mouth

Constipation
The placebo being used in this study’s control group is made from sugar. The amount 
of sugar used in this pill is too small to have any effect.
You will be assigned to either group by chance. It is not known if treatment with 
Guanfacine will prove to be effective or have more side effects than no treatment or 
non-study alternatives.
Benefits
You may or may not benefit directly from taking part in this study. However, this study 
may help us better understand how to treat delirium symptoms in critically ill patients 
in the future.
Alternatives
There is currently no standard drug to treat delirium. Current management is based on 
trying to prevent delirium. The alternative to participating in this study is to be treated 
with the hospital’s usual care approach. 
UAB IRB
Approved
18-Aug-2022
until
17-Aug-2023


Page 2 of 6
Version Date: 08/19/2020
Purpose of the Research Study
We are asking you to take part in a research study because you (or the individual for which you are the legal 
representative) have been diagnosed with delirium during your Intensive Care Unit stay. Delirium is a common 
problem in critically ill patients, and is associated with increased agitation, and an inability to correctly orient 
to person, place, time, and situation. Several risk factors associated with delirium include: advanced age, 
substance abuse, sleep disturbances, and other body metabolism disturbances.
The purpose of this research study is to test how well the drug Guanfacine, currently FDA approved to treat 
high blood pressure and Attention Deficit Hyperactivity Disorder (ADHD) symptoms, can help treat critically ill 
patients diagnosed with delirium in the Intensive Care Unit (ICU). This study will enroll approximately 200 
participants at UAB Hospital.
Study Participation & Procedures
If you agree to join the study, you will have an equal (50/50) chance of being assigned to the group receiving 
the study drug Guanfacine, or a placebo (sugar pill). A placebo does not have any active medicine, so it should 
not have any effect on you. You will be assigned randomly (by chance, like the flip of a coin) in a 1:1 ratio 
between the two study groups. The randomization scheme will be generated by the study statistician using a 
statistical software program. This is a double-blind study. This means neither you nor your doctors will know 
which study drug you are taking. If necessary, the doctor can find out which you are taking.

You will take your assigned study medication by mouth (or if you already have a small tube inserted 
through your nose into your stomach) once nightly if indicated for up to 14 consecutive days or until ICU 
discharge, whichever comes first.

A member of the study team will conduct a brief mental alertness assessment with you twice daily (in the 
morning and evening) while you are taking the assigned study medication.

If you are entered and complete the entire study, you will be in the study for up to 90 days.

If you are discharged from the hospital before Day 28, you will be contacted by a member of the study 
staff on Days 28 and 90 to complete a brief follow-up assessment.
Additional Information:
Your de-identified information that we collect (private information with all personal identifiers removed) may 
be used for future research studies or used by another researcher for future research studies without 
additional informed consent.
Risks and Discomforts
The medication used in this study, Guanfacine, is a medication usually used to treat high blood pressure. You 
may experience some side effects from taking the study drug.
The side effects of Guanfacine are:

Lower heart rate

Lower blood pressure

Sleepiness

Dizziness

Dry mouth

Constipation


Page 3 of 6
Version Date: 08/19/2020
The placebo being used in this study’s control group is made from sugar. The amount of sugar used in this pill 
is too small to have any effect on you.
You will be assigned to either group by chance. It is not known if treatment with Guanfacine will prove to be 
effective or have more side effects than no treatment or non-study alternatives.
Benefits
You may or may not benefit directly from taking part in this study. However, this study may help us better 
understand how to treat delirium symptoms in critically ill patients in the future by increasing the healthcare 
professional’s overall awareness and treatment options for delirium. 
You will be assigned to either group by chance, which may prove to be more or less beneficial than the other 
study group.
Alternatives
There is no standard medication for treating delirium. Current management is based on trying to prevent 
delirium. One alternative may be not to participate in this study. In which case, the hospital’s current usual 
care approach will continue to be used and include non-medication based approaches to maintain wakeful 
days and restful nights, early mobilization activities, timely removal of physical restraints, and optimal pain 
control.
Confidentiality and Authorization to Use and Disclose Information for Research 
Purposes
Federal regulations give you certain rights related to your health information. These include the right to know 
who will be able to get the information and why they may be able to get it. The study doctor must get your 
authorization (permission) to use or give out any health information that might identify you.
What protected health information may be used and/or given to others?
All medical information, including but not limited to information and/or records of any diagnosis or treatment 
of disease or condition, which may include sexually transmitted diseases (e.g., HIV, etc.) or communicable 
diseases, drug/alcohol dependency, etc.; all personal identifiers, including but not limited to your name, social 
security number, medical record number, date of birth, dates of service, etc.; any past, present, and future 
history, examinations, laboratory results, imaging studies and reports and treatments of any kind, including but 
not limited to drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, 
including but not limited to copies of your medical bills; any other information related to or collected for use in 
the research study, regardless of whether the information was collected for research or non-research (e.g., 
treatment) purposes; records about any study drug you received or about study devices used; and consent 
forms from past studies that might be in your medical record.
Your consent form will be placed in your medical record at UAB Health System. This may include either a paper 
medical record or electronic medical record (EMR). An EMR is an electronic version of a paper medical record 
of your care within this health system. Your EMR may indicate that you are on a clinical trial and provide the 
name and contact information for the principal investigator.
If you are receiving care or have received care within this health system (outpatient or inpatient), results of 
research tests or procedures (i.e. laboratory tests, imaging studies and clinical procedures) may be placed in 
your existing medical record.


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Version Date: 08/19/2020
If you have never received care within this health system (outpatient or inpatient), a medical record will be 
created for you to maintain results of research tests or procedures.
All information within your medical record can be viewed by individuals authorized to access the record.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time.
Who may use and give out this information?
Information about your health may be used and given to others by the study doctor and staff. They might see 
the research information during and after the study.
Who might get this information?
All individuals/entities listed in the informed consent document(s), including but not limited to, the physicians, 
nurses and staff and others performing services related to the research (whether at UAB or elsewhere). Your 
information may also be given to the sponsor of this research. “Sponsor” includes any persons or companies 
that are working for or with the sponsor, or are owned by the sponsor, or are providing support to the sponsor 
(e.g., contract research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

the U.S. Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) agencies

Governmental agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

the University of Alabama at Birmingham - the physicians, nurses and staff working on the research study 
(whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, UAB Highlands Hospital, as 
necessary for their operations; the UAB IRB and its staff

the billing offices of UAB and UAB Health Systems affiliates and its billing agents
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry out the 
research study. The sponsor will analyze and evaluate the results of the study. In addition, people from the 
sponsor and its consultants will be visiting the research site. They will follow how the study is done, and they 
will be reviewing your information for this purpose.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health information listed above 
for the purposes described above. If you refuse to give permission, you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in this study and 
sign this permission form, you will not be allowed to look at or copy your information until after the research is 
completed.
May I withdraw or revoke (cancel) my permission?
Yes, but the use of your personal health information will continue until you formally cancel your permission.


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Version Date: 08/19/2020
You may withdraw or take away your permission to use and disclose your health information at any time. You 
do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to 
continue being in this study.
When you withdraw your permission, no new health information which might identify you will be gathered 
after that date. Information that has already been gathered may still be used and given to others. This would 
be done if it were necessary for the research to be reliable.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the information may 
no longer be protected. There is a risk that your information will be released to others. Including others 
outside of UAB, without your permission.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. 
If you decide not to be in the study, you will not lose any benefits you are otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not affect your 
relationship with this institution. However, you should return to see the study doctor for safety reasons so you 
can be taken off the study drug and referred for follow-up care. Contact the study doctor if you want to 
withdraw from the study.
You may be removed from the study without your consent if the study doctor decides it is not in the best 
interest of your health, or if you are not following the study rules.
If you are a UAB student or employee, taking part in this research is not a part of your UAB class work or 
duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, with no effect 
on your class standing, grades, or job at UAB. You will not be offered or receive any special consideration if you 
take part in this research.
Cost of Participation
There will be no cost to you for taking part in this study. All drugs related to this study will be provided to you 
at no cost during the 14-day study period. The costs of your standard medical care will be billed to you and/or 
your insurance company in the usual manner.
Payment for Participation
You will not be paid for your participation in this study.
Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this study. If such harm 
occurs, treatment will be provided. However, this treatment will not be provided free of charge.
New Findings
You will be told by the study doctor or the study staff if new information becomes available that might affect 
your choice to stay in the study.


Page 6 of 6
Version Date: 08/19/2020
Optional
If you are discharged from the hospital before Day 28 (after study enrollment), the study staff will contact you 
to complete a brief follow-up assessment on Days 28 and 90.
Initial your choice below:
_________ YES, I agree to allow the study staff to contact me for a follow-up assessment after my hospital 
discharge.
_________NO, I do NOT agree to allow the study staff to contact me for a follow-up assessment after my 
hospital discharge.
Questions
If you have any questions, concerns, or complaints about the research or a research-related injury including 
available treatments, please contact the study doctor. You may contact Dr. Andrew B. Barker at (205) 934-
4699 or after hours by paging him at: UAB Paging (205) 934-3411.
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or been read) the information provided above and agree to 
participate in this study. You will receive a copy of this signed consent form.
Signature of Participant
Date
Signature of Legally Authorized Representative
Date
Signature of Witness
Date
Signature of Person Obtaining Consent
Date