Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospe… (NCT07052851) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
200 participantsStarted 2025-07
Plain-language summary
Performance of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Double-Blind, Multi-center Trial
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has signed and dated the informed consent form (ICF).
. Age ≥18 years.
. Participants must have a KOOS Pain subscale score of 25≤75 in the index knee over the last week before screening.
. Participants must have a KOOS Symptoms subscale score of 30≤ 75 in the index knee over the last week before screening. Subjects must report at least moderate severity (score ≥2) in at least one of the following:
. Degenerative changes in the index knee that can be categorized as grade II -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographs of the knee.
. Body Mass Index (BMI) between 18.5 kg/m2 and 38 kg/m2
. A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of CCoat.
. If female, the subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26 w (26 weeks post injection).
Exclusion criteria
. Osteoarthritis of the index knee graded 4 according to the Kellgren- Lawrence Grading.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain score at 12 weeks