CClinicalTrials.gg
Sign In
CompletedNCT04341116Updated May 6, 2023Results posted

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

A Phase 2/3 interventional study of TJ003234 and Placebo in Coronavirus Disease 2019 COVID-19, sponsored by I-Mab Biopharma US Limited. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by I-Mab Biopharma US Limited · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coronavirus Disease 2019 COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 149 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

I-Mab Biopharma US Limited is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing
  • Subjects that require ECMO.
  • Pregnant or breastfeeding females.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    TJ003234 Medium Dose

    Drug: TJ003234

  • Experimental
    TJ003234 Low Dose

    Part 1 only

    Drug: TJ003234

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    TJ003234 High Dose

    Part 2 Phase 3 only

    Drug: TJ003234

Interventions

  • DrugTJ003234

    patients receive a single infusion

  • DrugPlacebo

    patients receive a single infusion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 through Day 30

Secondary outcomes

  1. 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.

    Time frame: Day 1 through Day 14

  2. 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.

    Time frame: Day 1 through Day 30

  3. All-cause Mortality Rate by Day 30

    The percentage of subjects who deceased by any cause.

    Time frame: Day 1 through Day 30

  4. Time to Recovery Among Subjects Alive by Day 30

    Time to sustained recovery

    Time frame: Day 1 through Day 30

  5. Length of Hospitalization

    Duration of hospitalization

    Time frame: Day 1 through Day 30

07

Results

Posted May 6, 2023

Participant flow

Participant flow — Overall Study
MilestoneTJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)
Started88877642
Completed76666534
Not completed1221118

Outcome measures

PrimaryPercentage 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.

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline
ParticipantsTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ0032034 10mg/kg (Part 2)Placebo (Part 2)
Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline——56527
Statistical analysis
  • TJ003234 6mg/kg (Part 2) vs TJ0032034 10mg/kg (Part 2) · Fisher Exact · p = .28 · Median difference (final values): 9 · 95% CI -6.5 to 27
SecondaryPercentage of Recovery by Day 14

Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.

Time frame:
Day 1 through Day 14
Reported as:
Count of participants · Participants
Percentage of Recovery by Day 14
ParticipantsTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)
Percentage of Recovery by Day 14——47520
SecondaryPercentage 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.

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
Percentage of Subjects Recovered on Day 30
ParticipantsTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)
Percentage of Subjects Recovered on Day 30——56527
SecondaryAll-cause Mortality Rate by Day 30

The percentage of subjects who deceased by any cause.

Time frame:
Day 1 through Day 30
Reported as:
Count of participants · Participants
All-cause Mortality Rate by Day 30
ParticipantsTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003204 10mg/kg (Part 2)Placebo (Part 2)
All-cause Mortality Rate by Day 30——719
SecondaryTime to Recovery Among Subjects Alive by Day 30

Time to sustained recovery

Time frame:
Day 1 through Day 30
Reported as:
Median · days
Time to Recovery Among Subjects Alive by Day 30
daysTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ004309 10mg/kg (Part 2)Placebo (Part 2)
Time to Recovery Among Subjects Alive by Day 30——8 (5 to 18)6.5 (4.0 to 10.0)10 (4 to 22)
SecondaryLength of Hospitalization

Duration of hospitalization

Time frame:
Day 1 through Day 30
Reported as:
Median · days
Length of Hospitalization
daysTJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)
Length of Hospitalization——10 (8 to 13)9.5 (1 to 12)11 (7 to 18)

Adverse events

Collected over All adverse events will be collected from the day of informed consent to Day 30.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TJ003234 3 mg/kg (Part 1)1/8 (12.5%)2/8 (25%)0/8 (0%)
TJ003234 6mg/kg (Part 1)1/8 (12.5%)4/8 (50%)0/8 (0%)
Placebo (Part 1)2/8 (25%)2/8 (25%)0/8 (0%)
TJ003234 6 mg/kg (Part 2)11/77 (14.3%)22/77 (28.6%)0/77 (0%)
TJ003234 10mg/kg (Part 2)1/6 (16.7%)1/6 (16.7%)0/6 (0%)
Placebo (Part 2)10/42 (23.8%)16/42 (38.1%)0/42 (0%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventTJ003234 3 mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6 mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)
(WORSENING) HYPOXIC RESPIRATORY FAILURERespiratory, thoracic and mediastinal disorders0/80/80/813/770/65/42
(Worsening) PNEUMONIA (due to COVID-19)Infections and infestations0/80/80/83/771/61/42
Cardiac ArrestCardiac disorders0/81/80/82/770/60/42
SEPTIC SHOCKInfections and infestations0/81/80/86/770/64/42
ACUTE KIDNEY INJURYRenal and urinary disorders1/80/80/82/770/63/42
COVID-19Infections and infestations1/81/81/80/770/60/42
PNEUMONIA BACTERIALInfections and infestations0/80/81/80/770/60/42
Staphylococcal bacteraemiaInfections and infestations0/80/81/80/770/60/42
MyopathyMusculoskeletal and connective tissue disorders0/81/80/80/770/60/42
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders0/80/81/80/770/60/42

Baseline characteristics

Age, Continuous
Age, Continuous(years)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Mean51.9 (36 to 80)58.4 (39 to 75)58 (19 to 80)55.6 (24 to 84)57.2 (31 to 75)56.4 (37 to 77)56 (19 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Female4344942488
Male4542821861
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Hispanic or Latino0113321653
Not Hispanic or Latino8774442696
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
American Indian or Alaska Native0002013
Asian0002024
Native Hawaiian or Other Pacific Islander0000011
Black or African American4332331046
White4553932177
More than one race000110617
Unknown or Not Reported0000011
Region of Enrollment
Region of Enrollment(participants)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
United States88877642149
Height
Height(cm)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Mean168.8 (144.8 to 190.5)166.8 (147.3 to 185.4)173.3 (160.0 to 190.5)167.1 (72.0 to 190.5)171.0 (160.0 to 182.9)168.3 (149.9 to 188.0)168.65 (72.0 to 190.5)
Weight
Weight(kg)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Mean101.4 (43.9 to 161.0)88.0 (74.0 to 138.3)108.9 (53.0 to 145.0)97.2 (43.9 to 161.0)98.1 (74.0 to 138.3)97.1 (53.0 to 145.0)98.3 (43.9 to 161.0)
Mechanical Ventilation
Mechanical Ventilation(Participants)TJ003234 3mg/kg (Part 1)TJ003234 6mg/kg (Part 1)Placebo (Part 1)TJ003234 6mg/kg (Part 2)TJ003234 10mg/kg (Part 2)Placebo (Part 2)Total
Yes333100625
No31267636115
Unknown2430009
08

Study locations

14 sites
  • University of Arkansas
    Little Rock, Arkansas 72205, United States
  • Olive View-UCLA Medical Center
    Sylmar, California 91342, United States
  • Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • The GW Medical Faculty Associates
    Washington, District of Columbia 20037, United States
  • University of Miami
    Miami, Florida 33146, United States
  • OSF Healthcare Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Indiana University Health
    Indianapolis, Indiana 46202, United States
  • Medpharmics, LLC
    Metairie, Louisiana 70006, United States
  • Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada 89102, United States
  • UNM Hospitals
    Albuquerque, New Mexico 87106, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
09

References and documents

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 ↗

Study documents

  • Study protocol · Sep 23, 2021
  • Statistical analysis plan · Apr 21, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04341116
Lead sponsor
I-Mab Biopharma US Limited
Responsible party
Sponsor
First posted
Apr 10, 2020
Start date
Apr 11, 2020
Primary completion
Feb 7, 2022
Completion
Feb 7, 2022
Results posted
May 6, 2023
Last update
May 6, 2023

Study contacts

Claire Xu, MD, PhD
study director · I-Mab Biopharma US Limited

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

I-Mab Biopharma US Limited

Start the discussion