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Trial record 2 of 5 for:    EQUINOX

A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 (EQUINOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605926
Recruitment Status : Withdrawn (Sponsor has currently elected to withhold study initiation)
First Posted : October 28, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Tracking Information
First Submitted Date  ICMJE October 21, 2020
First Posted Date  ICMJE October 28, 2020
Last Update Posted Date January 27, 2021
Estimated Study Start Date  ICMJE November 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
Proportion of subjects who have recovered at Day 28. [ Time Frame: Day 28 ]
Proportion of subjects who have recovered at Day 28.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
  • Proportion of subjects deceased or requiring mechanical ventilation at Day 28. [ Time Frame: Day 28 ]
    Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
  • Proportion of subjects deceased at Day 28. [ Time Frame: Day 28 ]
    Proportion of subjects deceased at Day 28.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2020)
  • Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Day 90 ]
    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
  • Time to maximum itolizumab serum concentration, Tmax [ Time Frame: Day 28 ]
    Time to maximum itolizumab serum concentration, Tmax
  • Maximum itolizumab serum drug concentration, Cmax [ Time Frame: Day 28 ]
    Maximum itolizumab serum drug concentration, Cmax
  • Total itolizumab exposure across time, AUC (from zero to last) [ Time Frame: Day 28 ]
    Total itolizumab exposure across time, AUC (from zero to last)
  • Inflammatory biomarkers [ Time Frame: Day 28 ]
    Including but not limited to IL-1, IL-6, IL-17, TNF-α.
  • Pharmacodynamic markers [ Time Frame: Day 28 ]
    sCD6, sALCAM
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
Brief Summary This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
Detailed Description This study will randomize up to 800 subjects in a 1:1 ratio; itolizumab vs. placebo. Subjects will receive either itolizumab or placebo administered intravenously on Day 1 and Day 8 with follow-up to Day 90. Two interim analyses of futility are planned. The first will take place when approximately 20% of the subjects have been evaluated for the primary endpoint, and the second will take place when approximately 50% of the subjects have been evaluated for the primary endpoint.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The study will be blinded to all study staff that has direct access to the subjects and the sponsor.
Primary Purpose: Treatment
Condition  ICMJE Coronavirus
Intervention  ICMJE
  • Biological: EQ001
    itolizumab [Bmab600]
    Other Names:
    • itolizumab
    • Bmab600
  • Biological: EQ001 Placebo
    EQ001 Placebo
Study Arms  ICMJE
  • Experimental: EQ001
    EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
    Intervention: Biological: EQ001
  • Placebo Comparator: EQ001 Placebo
    Placebo administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
    Intervention: Biological: EQ001 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 25, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2020)
800
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is willing and able to, or has a legally acceptable representative who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.
  2. Is male or female, age ≥18 years
  3. Is hospitalized with COVID-19 pneumonia with a diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent local test within 14 days of randomization.
  4. Has PaO2/FiO2 ratio of ≤200 (or equivalent SpO2/FiO2 ratio ~235 within 24 hours before randomization. This ratio may be adjusted based on altitude.

Exclusion Criteria:

  1. Has known severe allergic reactions to mAbs.
  2. Has active TB or known history of inadequately treated latent or active TB.
  3. Has any known active systemic or pulmonary bacterial, fungal, or viral (other than SARS-CoV-2) infection at the time of randomization.
  4. Has known active, uncontrolled hepatitis B or hepatitis C or severe liver function impairment from any etiology, as defined by Child-Pugh Class C.
  5. Has human immunodeficiency virus (HIV) with known CD4 counts <0.2 × 10^9/L.
  6. Has a history of clinically significant cardiac abnormality within 6 months prior to randomization, such as myocardial infarction or stroke, New York Heart Association class III or IV, or clinically significant abnormalities of electrocardiogram (ECG) or cardiac function.
  7. Has been on mechanical ventilation for longer than 48 hours during their first continuous episode since admission, is on their second or greater episode of mechanical ventilation at the time of randomization during the concurrent hospitalization, or has received extracorporeal membrane oxygenation (ECMO).
  8. Has a declining clinical status with an expected survival <3 days in the opinion of the Investigator.
  9. Has received any systemic immunomodulatory or immunosuppressant agents for any condition within 3 months prior to randomization. (Note: a stable, oral, low dose of corticosteroids [prednisone or equivalent ≤10 mg/day] for a chronic condition or any dose of systemic corticosteroids for current COVID-19 treatment are permitted. Local/topical treatments are also permitted.)
  10. Has received any biologic treatment for any acute (eg, COVID-19) or chronic conditions (eg, TNFα inhibitors, anti-IL17A, tocilizumab, anti-cytokines, etc.) within 3 months prior to randomization.
  11. Is participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives (whichever is longer) prior to randomization.
  12. Is pregnant or breastfeeding, or has a positive pregnancy serum or urine test during Screening.
  13. Does not agree to use contraception in the event of sexual activity for 130 days (+90 days for male subjects) after the last dose of study drug if a female of childbearing potential or a male with a partner of childbearing potential. Note: this criterion does not apply to subjects in same-sex relationships.
  14. Has inadequate hematologic function during Screening defined as follows:

    • Absolute neutrophil count (ANC) <1.0 × 109/L.
    • ALC <0.5 × 109/L.
  15. Requires renal dialysis, either acute or chronic, at the time of randomization.
  16. Has a medical, psychiatric, or other condition or circumstance that, in the opinion of the Investigator, could affect the subject's safety, the subject's participation in the study, or the reliability of the study data.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04605926
Other Study ID Numbers  ICMJE EQ001-20-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Equillium
Study Sponsor  ICMJE Equillium
Collaborators  ICMJE Biocon Limited
Investigators  ICMJE
Study Director: Maple Fung, MD Equillium
PRS Account Equillium
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP