OL 5309-0008 COVID-19 clinical trial

San Antonio - Texas

ICON Early Phase Services is conducting a research study for healthy males and females ages 18 to 55. The purpose of this study is to test the safety and tolerability of a single dose of an investigational medication (will be given as an Intramuscular injection or IV infusion).  The investigational medication is being investigated for the treatment and prevention of COVID-19 in adults.

Click Here to make an appointment for OL 5309-0008

Or call 210-225-5437 for more information

 

Vital signs, ECGs, physical examinations, pregnancy and alcohol testing will be performed. Blood/nasal swabs and urine samples will also be obtained during this study. 

Participants will complete:

  •  Up to 2 screening visits
  • 2 consecutive overnights
  • 13 outpatients visits
  • 2 phone calls

To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date.  For more information, see below.

Qualified participants may be compensated up to $6,800 for time and travel.

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

  • I am a healthy adult between the ages of 18 and 55 years of age, meaning no significant medical conditions
  • My BMI is between ≥18.5 and ≤35 kg/m2
  • I have not received an investigational drug within the last 28 days before  dosing for this study and I do not plan to enroll in another clinical trial including a drug, biologic or device
  • I have suitable veins for multiple blood samples
  • If Female, I am not pregnant or breastfeeding and if able to have children, agree to use an acceptable form of contraception for the duration of the study such as Progestin implants, IUDs, surgical (hysterectomy or tubal ligation, vasectomy) or abstinence.  The use of progestin injectables, combined oral hormonal contraceptives, condoms and diaphragms will only be acceptable if used in combination with another method.  (For example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterilized male partner use a double-barrier methods).
  • If female, I am not able to have children and meet one of the following criteria – postmenopausal or surgically sterile (defined as bilateral oophorectomy, or hysterectomy)
  • If Male, I am willing to use condoms for the duration of the study
  • I agree to minimize my risk of exposure to COVID-19
  • I agree not to smoke while staying in the CRU and to abide by the rules of the clinic, which is a non-smoking facility 
  • I am able to communicate effectively in English with the study personnel

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  

No guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

To determine if you fully qualify, it will be necessary to obtain blood and urine  samples after an 8-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport.  You will be required to show this same photo ID at all study visits.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

CLICK HERE To Make An Appointment For OL 5309-0008

 

STUDY DATES - Note: All dates and times are tentative and may change.

  Cohort 4B Cohort 4C Cohort 5a
Admit Jan 21, 2021 Jan 24, 2021 Jan 26, 2021
Discharge Jan 23 Jan 26 Jan 28
Day 3 outpatient visit Jan 24 Jan 27 Jan 29
Day 4 outpatient visit Jan 25 Jan 28 Jan 30
Day 8 outpatient visit Jan 29 Feb 01 Feb 03
Day 15 outpatient visit Feb 05 Feb 08 Feb 10
Day 30 outpatient visit Feb 20 Feb 23 Feb 25
Day 45 outpatient visit Mar 07 Mar 10 Mar 12
Day 60 outpatient visit Mar 22 Mar 25 Mar 27
Day 90 outpatient visit Apr 21 Apr 24 Apr 26
Day 120 outpatient visit May 21 May 24 May 26
Day 150 outpatient visit Jun 20 Jun23 Jun 25
Day 180 outpatient visit Jul 20 Jul 23 Jul 25
Day 270 Telephone call Oct 18 Out 21 Out 23
Day 360 outpatient visit Jan 16, 2022 Jan 19, 2022 Jan 21, 2022
Day 450 Telephone call Apr 16 Apr 19 Apr 21
Day 540 End of study visit Jul 15 Jul 18 Jul 20

 

 

Notice:

In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.  

 

PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

Name
OL 5309-0008
Details
Healthy Adults - BMI 18.5 to 35.0. New appointments! NEW DATES!
Gender
Male or Female
Payment amount
up to $6,800
Age
18 - 55