CoronavirusPhase 3EQUINOXNCT04605926
A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19
A Phase 3 study testing EQ001 in people with Coronavirus, run by Biocon Limited at 1 site in Colombia.
Trial summary
This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus
- What is being tested?
- EQ001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2020to Jun 2021
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- ALC <0.5 × 109/L.
- Requires renal dialysis, either acute or chronic, at the time of randomization.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
Read the 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.
- Conditions
- Coronavirus
- Being tested
- EQ001, EQ001 Placebo
- Keywords
- COVID-19, SARS-CoV-2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ001Biological
Also called itolizumab, Bmab600
itolizumab [Bmab600]
EQ001 PlaceboBiological
EQ001 Placebo
| Study group | Role | What they receive |
|---|---|---|
| EQ001 | Experimental | EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses. Receives: 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. Receives: Biological: EQ001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have recovered at Day 28.
Proportion of subjects who have recovered at Day 28.
Measured: Day 28
Secondary outcomes (2)
Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
Measured: Day 28
Proportion of subjects deceased at Day 28.
Proportion of subjects deceased at Day 28.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Sponsor has currently elected to withhold study initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maple Fung, MD, Study director, Equillium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605926
- Sponsor's protocol ID
- EQ001-20-001
- Acronym
- EQUINOX
- Status last verified
- May 2026
- First submitted
- 21 Oct 2020
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
- ClinicalTrials.gov ID
- NCT04605926
- Acronym / sponsor ID
- EQUINOX / EQ001-20-001
- Conditions
- Coronavirus
- Keywords
- COVID-19, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has currently elected to withhold study initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biocon LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EQ001 | Experimental | Biological: EQ001EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses. |
| EQ001 Placebo | Placebo comparator | Biological: EQ001 PlaceboPlacebo administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ001Also: itolizumab, Bmab600itolizumab [Bmab600] | Biological | EQ001 |
| EQ001 PlaceboEQ001 Placebo | Biological | EQ001 Placebo |
Primary outcome
Proportion of subjects who have recovered at Day 28.
Time frame: Day 28
Proportion of subjects who have recovered at Day 28.
2 secondary outcomes
Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
Time frame: Day 28
Proportion of subjects deceased at Day 28.
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maple Fung, MD study director
Equillium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EQ001 in people with Coronavirus, run by Biocon Limited at 1 site in Colombia.
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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects who have recovered at Day 28. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.