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Knee OsteoarthritisNCT05771948

Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

A study testing CCoat in people with Knee Osteoarthritis, run by Lipo-Sphere at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the Efficacy and Safety of CCoat Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis. The main questions it aims to answer are: To demonstrate superior efficacy of CCoat administered via intra-articular injection versus placebo during the study period. Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
CCoat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
3 sitesIsrael
Study dates
16 Mar 2023to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has signed and dated the informed consent form
  • Age ≥30 and ≤ 85 years old
  • Pain in the intended study knee with an average VAS score (active) of ≥3 over the last week before screening.
  • Degenerative changes in the intended study knee that can be categorized as grade I -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographsof the knee
  • Body Mass Index (BMI) between 18.5 and 38
  • A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint.
  • 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 26w (26 weeks post injection).
  • Are willing or able to comply with procedures required in this protocol.

Who cannot join

  • Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
  • History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening
  • Pain in both knees with a VAS score of ≥5
  • Intra-articular injection to the intended study knee within 3 months before Screening
  • Significant instability of the index knee
  • Malalignment more than 10 degrees varus OR 10 degrees valgus according to standing X-ray
Show all 24Show fewer
  • Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
  • History of Psoriatic Arthritis, Rheumatoid Arthritis, or any other inflammatory condition associated with arthritis
  • Wound in the area of the intended study knee
  • Any known tumor of the index knee
  • Any known history of intra-articular or osseous infection of the index knee
  • Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
  • Any known history of inflammatory arthropathy or crystal-deposition arthropathy
  • Any known systemic cartilage and/or bone disorder, such as but not limited to, chondrodysplasia or osteogenesis imperfecta
  • Body Mass Index (BMI) > 38
  • Active malignances, excluding BCC.
  • Chemotherapy and/or radiation in the past 12 months
  • Known history of a severe allergic reaction
  • Patient who is pregnant or intends to become pregnant during the study
  • History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
  • A Known substance or alcohol abuse
  • Participation in other clinical trials within 60 days to before the study or concurrent with the study
  • Known insulin dependent diabetes mellitus
  • Unable to undergo X-ray

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Assuta

    Ashdod

  • Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot

Other trials in Israel

About this study

Official title: Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis: Prospective, Placebo Controlled, Randomized, Double-Blinded Study

The goal of this clinical trial is to evaluate the Efficacy and Safety of CCoat Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis.

The main questions it aims to answer are:

  • To demonstrate superior efficacy of CCoat administered via intra-articular injection versus placebo during the study period.
  • To evaluate the efficacy of two different concentrations of CCoat, administered via single IA injection as compared to control group (placebo) One IA injection of CCoat or Placebo will be injected to participants' knee. Follow up will take place up to six months.
  • To evaluate the safety of the repeated CCoat injection administered at six months.
Read the detailed description

This study aims to assess the effectiveness and safety of intra-articular injection of Aqueous Joint at two different concentrations administered via a single injection in osteoarthritic patients up to 26 weeks of follow-up in a double-blind, randomized clinical study. Additionally, the safety of the repeated injection will be examined.

Primary Effectiveness Objective The primary objective is to demonstrate the superior effectiveness of CCoat administered via single intra-articular injection versus placebo during the study period in terms of functional outcomes as assessed in terms of Pain KOOS subscore at each FU visit (up to and including 12 weeks) and compared to the baseline levels.

Secondary Effectiveness Objective The secondary objective is to assess changes from baseline to 26 weeks in NRS, KOOS symptoms, QOL, ADL and sport subscores. Change from Baseline in Patient's Global Assessment (PGA)) of Osteoarthritis at Week 26 were evaluated. Patients responder rates will be evaluated at 12 and 26 weeks.

Safety Objectives Safety will be evaluated by the occurrence of Adverse Events during the study. Adverse Events will be reported in terms of incidence, severity, and frequency of all Adverse Events (AE).

Clinical Hypotheses The underlying clinical hypothesis of this study is that the CCoat is superior to the control group in terms of KOOS score (Pain, Symptoms, QOL, ADL \& Sports) at 3 months compared to baseline, even more in a high concentration.

Being tested
CCoat
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCoatDevice

    CCoat is a new intra-articular (IA) injectable joint lubricant for patients suffering from joint pain developed by Liposphere LTD. CCoat is a liposomal boundary lubricant which coats the cartilage surface and protects it from further damage and degradation.

Study groups in NCT05771948
Study groupRoleWhat they receive
Group 1 (Control)Placebo comparator1 IA injection of 4 ml Normal Saline solution.
Receives: Device: CCoat
Group 2 (Study)Experimental1 IA injection of 4 ml CCoat
Receives: Device: CCoat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Osteoarthritis Outcome Score (KOOS) PAIN

    Change from baseline in patients KOOS pain over the course of the 12-week initial treatment period as measured by using the Knee injury and Osteoarthritis Outcome Score (KOOS) in following subscore: Pain- [Time Frame: Day 0, up to week 12]

    The responses for the KOOS Pain subscale are then summed and transformed into a score ranging from 0 to 100, where:

    0 represents extreme problems (maximum pain) 100 represents no problems (no pain)

    Measured: Baseline up to 12 weeks

Secondary outcomes (5)

  1. Numerical Rating Scale (NRS) Pain Score

    Change in Numerical Rating Scale (NRS) Pain.

    The NRS asks patients to rate their pain on a scale from 0 to 10, where:

    0 represents "No pain" 10 represents "Worst possible pain"

    Measured: Assessed at1, 6, 12, and 26 weeks from baseline.

  2. PGA

    Change in Patient's Global Assessment (PGA). PGA assessment includes 5 options to answer - between 1 to 5 - which 1 means 'very good' , and 5 means 'very poor'.

    Measured: Baseline to 6,12 and26 weeks

  3. Knee Injury and Osteoarthritis Outcome Score Responder Rates

    A responder is defined as an improvement of at least 8 points or ≥ 20% from baseline in the each of the KOOS subscores (Pain; Activities of Daily Living (ADL);Quality of Life (QOL);Symptoms; Sports; Overall KOOS score)

    The MCID is the smallest change in a score that patients perceive as beneficial. For the KOOS, an improvement of around 8 points in a subscale score is often considered a clinically meaningful change.

    A patient might be considered a responder if they achieve at least the MCID in one or more of the KOOS subscales (Pain, ADL, Sports, Symptoms, QOL).

    Measured: Baseline to 12 weeks

  4. Subscores-Specific KOOS Improvements

    Measured Change in the following KOOS subscores ( pain, ADL, sports, symptoms, QOL)

    Each of the five KOOS subscales is scored separately on a scale from 0 to 100, where 0 represents extreme problems and 100 represents no problems.

    Calculate the Change:

    Subtract the baseline score from the follow-up score for each subscale. Change in KOOS Subscale = Follow-Up Score - Baseline Score A positive change indicates improvement (e.g., less pain, better ADL, better sports function).

    A negative change indicates worsening (e.g., more pain, worse ADL).

    Measured: Baseline to 6,12 and26 weeks

  5. Safety Adverse events, including serious adverse events

    Adverse events, including serious adverse events

    Measured: baseline to 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start16 Mar 2023
  3. Primary completion1 Mar 2025
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05771948
Sponsor's protocol ID
CLD-0000616
Status last verified
Aug 2024
First submitted
5 Mar 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CCoat in people with Knee Osteoarthritis, run by Lipo-Sphere at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Osteoarthritis Outcome Score (KOOS) PAIN (time frame: Baseline up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05771948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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