COVID-19 Clinical Trial

San Antonio - Texas


ICON Early Phase Services is conducting a research study for healthy adults ages 18-49. The purpose of this study is to test a potential vaccine for COVID-19.   


Vital signs, physical examinations, pregnancy testing, drug and alcohol screens will be performed. Blood, urine and nasopharyngeal samples will also be obtained during this study.  
 
Participants will complete:


• 1 screening visit
• 10 outpatient visits 


To determine if you fully qualify, it will be necessary to obtain blood samples after an 8-hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening. 

For more information, see below.


Qualified participants may be compensated up to $2,000 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, meaning no significant medical conditions


• I am between 18 and 49 years old


• My BMI is between 18.0 and 34.0 kg/m2


• I have not tested positive for COVID-19


• I am not at an increased risk of exposure to COVID-19 such as a healthcare worker or emergency responder


• I have not been in close contact to anyone known to have the COVID-19 infection in the last 30 days


• I have not received any investigational drug or experimental procedure  in a clinical trial within 1 month prior to enrolling into this study


• I have not received any SARS-CoV-2 or other experimental coronavirus vaccine at anytime


• If Female, I am not pregnant or breastfeeding   

 
• If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control during the study.  Methods of birth control include:  

  • Hormonal contraception (oral, implant, injectable) in combination with condoms (with spermicide)
  • Barrier (condom, diaphragm with spermicide)
  • IUD
  • Vasectomized partner 
  • Heterosexual abstinence if this is the preferred and usual lifestyle 


• If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 months or I am surgically sterile (tubes tied, uterus removed, tubes removed or ovaries removed).   
• If Male and I have a partner capable of becoming pregnant, I agree to use a condom 

• If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above 

• I am able to communicate effectively in English with the study personnel 

• I do not plan to travel outside the US during the study

• I have not donated blood or blood products within the 6 weeks prior to this study

• I have not had a recent history of alcoholism or drug/chemical abuse

• I have not had cancer within the past 5 years (except for skin cancer or cancer in situ)

 
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.  We will be testing for alcohol  and drug of abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening 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 KE4516-0007


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

  Cohort 2
Outpatient visit - dose (post dose 1hr observation) Feb 02, 2021
Outpatient visit Feb 09
Outpatient visit Feb 16
Outpatient visit - dose (post dose 1hr observation) Feb 23
Outpatient visit Mar 02
Outpatient visit Mar 16
Phone call Apr 18
Outpatient visit May 02
Phone call Jun 01
Phone call Jul 01
Outpatient visit Aug 01
Outpatient visit Nov 01
Outpatient visit - End of study Feb 01, 2022

 

 


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
KE 4516-0007 Part A
Details
Healthy Adults - BMI 18.0 to 34.0. $100 Refer A Friend - NEW DATES!
Gender
Male or Female
Payment amount
up to $2,000
Age
18 - 49