ICON Early Phase Services is conducting a research study for healthy adults. The purpose of this study is to test a potential vaccine for COVID-19.
Clinical trial study for healthy study for healthy adults – KE 4516-0007
Trial Details
Study Description
Eligibility Criteria
Age
18 to 49
Gender
Both
Details
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.
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.
Health Condition
Healthy Volunteer
Stipend Range
$2000 - $2000
Name of Clinical Site
ICON Early Phase Services
Location
San Antonio TX
Phone
(210) 225-5437
Trial Sponsor
ICON Early Phase Services
Protocol Number
KE 4516-0007
Phase
1
Study Length
1 weeks
Overnight
No -
Location
8307 Gault Lane, San Antonio, TX, USA
Clinical Trial Site
ICON Early Phase Services
8307 Gault Lane, San Antonio, TX, USA
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