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

NCT04605926 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: EQ001-20-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.

Conditions

Coronavirus

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who have recovered at Day 28.

  Proportion of subjects who have recovered at Day 28.

  Day 28

Secondary Outcomes (2)

• Proportion of subjects deceased or requiring mechanical ventilation at Day 28.

  Day 28

• Proportion of subjects deceased at Day 28.

  Day 28

Other Outcomes (6)

• Incidence of treatment-emergent adverse events (TEAEs).

  Day 90

• Time to maximum itolizumab serum concentration, Tmax

  Day 28

• Maximum itolizumab serum drug concentration, Cmax

  Day 28

Study Arms (2)

EQ001

EXPERIMENTAL

EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.

Biological: EQ001

EQ001 Placebo

PLACEBO COMPARATOR

Placebo administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.

Biological: EQ001 Placebo

Interventions

EQ001 BIOLOGICAL

itolizumab \[Bmab600\]

Also known as: itolizumab, Bmab600

EQ001

EQ001 Placebo BIOLOGICAL

EQ001 Placebo

EQ001 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Is male or female, age ≥18 years
• 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.
• 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.

You may not qualify if:

• Has known severe allergic reactions to mAbs.
• Has active TB or known history of inadequately treated latent or active TB.
• Has any known active systemic or pulmonary bacterial, fungal, or viral (other than SARS-CoV-2) infection at the time of randomization.
• Has known active, uncontrolled hepatitis B or hepatitis C or severe liver function impairment from any etiology, as defined by Child-Pugh Class C.
• Has human immunodeficiency virus (HIV) with known CD4 counts \<0.2 × 10\^9/L.
• 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.
• 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).
• Has a declining clinical status with an expected survival \<3 days in the opinion of the Investigator.
• 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.)
• 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.
• 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.
• Is pregnant or breastfeeding, or has a positive pregnancy serum or urine test during Screening.
• 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.
• Has inadequate hematologic function during Screening defined as follows:
• Absolute neutrophil count (ANC) \<1.0 × 109/L.

Sponsors & Collaborators

• Equillium: lead
• Biocon Limited: collaborator

Study Sites (1)

Inv Site CO01

Medellín, Colombia

Location

Related Links

• Company website

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maple Fung, MD

  Equillium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be blinded to all study staff that has direct access to the subjects and the sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: November 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)