Coronavirus Disease 2019 COVID-19Phase 2/3NCT04341116

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

A Phase 2/3 study testing TJ003234 in people with Coronavirus Disease 2019 COVID-19, run by I-Mab Biopharma US Limited at 14 sites in United States.

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

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronavirus Disease 2019 COVID-19
What is being tested?: TJ003234
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 14 sitesUnited States
Study dates: 11 Apr 2020to 7 Feb 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age: 18 years or older (including 18 years); male or female
Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay.
Bilateral lung infection confirmed by imaging.
Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
Hospitalized for no more than 5 calendar days at the time of screening

Who cannot join

Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only).
Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis.
Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8 g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/L.
Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs.

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Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing
Subjects that require ECMO.
Pregnant or breastfeeding females.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

UNM Hospitals
Albuquerque, New Mexico, 87106
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University Health
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
University of Arkansas
Little Rock, Arkansas, 72205
Medpharmics, LLC
Metairie, Louisiana, 70006
University of Miami
Miami, Florida, 33146
Ochsner Medical Center
New Orleans, Louisiana, 70121
OSF Healthcare Saint Francis Medical Center
Peoria, Illinois, 61637
Olive View-UCLA Medical Center
Sylmar, California, 91342
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

Conditions: Coronavirus Disease 2019 COVID-19
Being tested: TJ003234, Placebo

What participants receive

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

TJ003234Drug
patients receive a single infusion
PlaceboDrug
patients receive a single infusion

Study groups in NCT04341116
Study group	Role	What they receive
TJ003234 Medium Dose	Experimental	Not described Receives: Drug: TJ003234
TJ003234 Low Dose	Experimental	Part 1 only Receives: Drug: TJ003234
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
TJ003234 High Dose	Experimental	Part 2 Phase 3 only Receives: Drug: TJ003234

What is being measured

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

Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale.
8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
Measured: Day 1 through Day 30

Secondary outcomes (5)

Percentage of Recovery by Day 14
Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
Measured: Day 1 through Day 14
Percentage of Subjects Recovered on Day 30
Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.
Measured: Day 1 through Day 30
All-cause Mortality Rate by Day 30
The percentage of subjects who deceased by any cause.
Measured: Day 1 through Day 30
Time to Recovery Among Subjects Alive by Day 30
Time to sustained recovery
Measured: Day 1 through Day 30
Length of Hospitalization
Duration of hospitalization
Measured: Day 1 through Day 30

Timeline

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

11 Apr 20207 Feb 2022

First posted10 Apr 2020
Study start11 Apr 2020
Primary completion7 Feb 2022
Study completion7 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019 COVID-19Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04341116
Sponsor's protocol ID: TJ003234COV201
Status last verified: May 2023
First submitted: 4 Apr 2020
Last updated: 6 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronavirus Disease 2019 COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19)
ClinicalTrials.gov ID: NCT04341116
Acronym / sponsor ID: TJ003234COV201
Conditions: Coronavirus Disease 2019 COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
Study start: 11 Apr 2020 (actual)
Primary completion: 7 Feb 2022 (actual)
Study completion: 7 Feb 2022 (actual)
First posted: 10 Apr 2020 (actual)
Results: Posted 6 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TJ003234 Medium Dose	Experimental	Drug: TJ003234
TJ003234 Low Dose	Experimental	Drug: TJ003234Part 1 only
Placebo	Placebo comparator	Drug: Placebo
TJ003234 High Dose	Experimental	Drug: TJ003234Part 2 Phase 3 only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: 18 years or older (including 18 years); male or female
Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay.
Bilateral lung infection confirmed by imaging.
Severe disease that meets one of the following conditions: (i) At rest, finger blood oxygen saturation ≤ 93% or PaO2/FiO2 ≤ 300 mmHg; (ii) Requiring non-invasive or invasive mechanical ventilation; OR (iii) Requiring high flow oxygen ≥ 15L/min
Hospitalized for no more than 5 calendar days at the time of screening

Key exclusion criteria (9 listed)

Any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
Chronic obstructive pulmonary disease (COPD) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (Part 1 only).
Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis.
Cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8 g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/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
TJ003234patients receive a single infusion	Drug	TJ003234 High Dose, TJ003234 Low Dose, TJ003234 Medium Dose
Placebopatients receive a single infusion	Drug	Placebo

Primary outcome

Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline
Time frame: Day 1 through Day 30
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.

5 secondary outcomes

Percentage of Recovery by Day 14
Time frame: Day 1 through Day 14
Percentage of Subjects Recovered on Day 30
Time frame: Day 1 through Day 30
All-cause Mortality Rate by Day 30
Time frame: Day 1 through Day 30
Time to Recovery Among Subjects Alive by Day 30
Time frame: Day 1 through Day 30
Length of Hospitalization
Time frame: Day 1 through Day 30

Results and safety

Results posted to the registry on 6 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TJ003234 3mg/kg (Part 1)	8	7
TJ003234 6mg/kg (Part 1)	8	6
Placebo (Part 1)	8	6
TJ003234 6mg/kg (Part 2)	77	66
TJ003234 10mg/kg (Part 2)	6	5
Placebo (Part 2)	42	34

Primary outcome: Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline

Time frame: Day 1 through Day 30. Count of participants. Unit: Participants

Measure	TJ003234 6mg/kg (Part 1) n = 0	Placebo (Part 1) n = 0	TJ003234 6mg/kg (Part 2) n = 67	TJ0032034 10mg/kg (Part 2) n = 6	Placebo (Part 2) n = 36
Value	–	–	56	5	27

TJ003234 6mg/kg (Part 2) vs TJ0032034 10mg/kg (Part 2): Median Difference (Final Values): 9 (95% CI -6.5 to 27), p = .28, Fisher Exact

Population analysed: All subjects randomized to treatment who were mechanical ventilation free at baseline was collected only for Part 2 arms/groups. Data was not collected from the Part 1 Arms/Groups.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events will be collected from the day of informed consent to Day 30.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TJ003234 3 mg/kg (Part 1)	2 of 8 (25%)	0 of 8 (0%)	1 of 8
TJ003234 6mg/kg (Part 1)	4 of 8 (50%)	0 of 8 (0%)	1 of 8
Placebo (Part 1)	2 of 8 (25%)	0 of 8 (0%)	2 of 8
TJ003234 6 mg/kg (Part 2)	22 of 77 (28.6%)	0 of 77 (0%)	11 of 77
TJ003234 10mg/kg (Part 2)	1 of 6 (16.7%)	0 of 6 (0%)	1 of 6
Placebo (Part 2)	16 of 42 (38.1%)	0 of 42 (0%)	10 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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.

Claire Xu, MD, PhD study director

I-Mab Biopharma US Limited

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TJ003234 in people with Coronavirus Disease 2019 COVID-19, run by I-Mab Biopharma US Limited at 14 sites in United States.

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 5 inclusion and 9 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline (time frame: Day 1 through Day 30). 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 NCT04341116, which also lists 1 linked publication.

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 6 May 2023.