Lakeside Research is currently recruiting for adult and child participants for clinical trials into the latest technologies to fight Covid and Cytomegalovirus (CMV).
The trials,which are open to any eligible participants, not just Lakeside patients, are conducted from a dedicated Research hub at Corby's Urgent Care Centre and they involve an initial assessment and follow up visits. Three of the studies are for Moderna while the fourth is for Gilead:
Here's a brief overview of the studies and who can get involved:
What is it?
If you have been recently diagnosed with COVID-19 you may be interested in the BIRCH Study. This tests the effectiveness and safety of a potential new oral drug for COVID-19 called GS-5245. Researchers want to see if it can lower the chance for serious disease and the need to be hospitalised. If you either have confirmed COVID-19 or you would like a lateral flow test from Lakeside Research we would be happy to supply one or you can collect a test from our site at the Urgent Care Centre, Cottingham Road, Corby.
Who can join the study?
What happens during the study?
The study lasts about 29 days with at least 6 visits for tests and health checks. A few of the visits will be in person. Others may be in person, on the computer or over the telephone.
To see if you qualify the study team will first collect information about your health and medical history and run some tests. You will then be placed by chance into a group to take either the study drug GS-5245 or a placebo. The placebo looks like GS-5245 but does not have any active medicine in it. You will take either the study drug or placebo tablet by mouth twice a day without food for 5 days.
What is it?
The NextCOVE Study is testing an investigational vaccine for COVID-19 called mRNA-1283.222. The vaccine is bivalent which means that it has been designed to fight against multiple different types, or variants of the virus that causes COVID-19, including the Omicron variant. Moderna will be evaluating this investigational vaccine as a booster dose in children and adults to learn more about how it works in the body.
Who can join the study?
What happens during the study?
Participation in this trial will last about 13 months. After the screening visit this includes up to 6 trial site visits and 3 safety phone calls to check on your health. Participants will be chosen at random to receive either the investigational booster dose or mRNA-1283.22 or mRNA-1273/222.
CMV (cytomegalovirus) is a highly contagious viral infection that can harm an unborn child. It is a common virus that is often overlooked because healthy people who get it rarely show symptoms. But if a woman becomes infected with CMV while she is pregnant she can pass the infection to her unborn baby. This can cause her child to suffer long-term disability due to birth defects, including hearing loss or even death in very severe cases.
Two trials are running:
Please contact the Lakeside team to see eligibility criteria.
The total length of participation in this clinical trial is approximately 2½ years (30 months). Clinical trial volunteers will have a screening visit to check whether they are eligible to participate. The visit includes a wellness exam, review of your medical history, a urine pregnancy test, and some blood tests.
During the first 7 months, trial participants will attend 6 in-person visits, including 1 screening visit and 3 vaccination visits when they'll receive injections in the upper arm.
During the follow-up portion of the trial (Month 8 through Month 30), participants will have in-person visits every 3 months and will provide updates via an eDiary, may be contacted by telephone, or may be requested to come in for unscheduled visits in between such visits.
Each participant has a 50% chance of receiving the investigational vaccine and a 50% chance of receiving a placebo—like flipping a coin.
Participants will visit the clinic 12 times over 18 months. In the first six months participants will get a jab in the arm three different times. During the other visits about 2 tablespoons of blood will be taken to find out if your body is making antibodies. You'll have health checkups during these visits, similar to a regular visits to the GP's office in which we will measure your height and weight, take your temperature and check your blood pressure. When you get a jab, and for the next 6 days your parent(s) or person taking care of you will add information to the app about your temperature, whether you have any redness or sweinng where you got the jab, and whether you took any medicine.