Phase 2
Completed N=396
A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia
Source: ClinicalTrials.gov NCT04386616 ↗Enrolled (actual)
396
Serious AEs
27.8%
Results posted
Jan 2022
Primary outcomePrimary: Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28 — 10.0; 11.0; 10.0 Days — p=0.9266
Summary
This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recovery, Defined as the Time to a Clinical Status Score of 1 or 2 on the 7-Category Ordinal Scale (Whichever Occurs First) by Day 28 |
10.0; 11.0; 10.0 | 0.9266 |
| SECONDARY Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status by Day 28 |
10.0; 11.0; 10.0 | 0.8373 |
| SECONDARY Time to Hospital Discharge or "Ready for Discharge" by Day 28 |
10.0; 11.0; 10.0 | 0.4711 |
| SECONDARY Duration of Supplemental Oxygen by Day 28 |
18.00; 17.00; 13.50 | 0.5304 |
| SECONDARY Percentage of Participants Alive and Free of Respiratory Failure by Day 28 |
38.1; 39.2; 40.2 | 0.8451 |
| SECONDARY Clinical Status Score at Day 14, Assessed Using a 7-Category Ordinal Scale |
1.0; 1.0; 1.0 | 0.5273 |
| SECONDARY Clinical Status Score at Day 28, Assessed Using a 7-Category Ordinal Scale |
1.0; 1.0; 1.0 | 0.3401 |
| SECONDARY Percentage of Participants Needing Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Day 28 |
24.6; 28.5; 24.2 | 0.4804 |
| SECONDARY Number of Ventilator-Free Days by Day 28 |
28.0; 28.0; 28.0 | 0.8007 |
| SECONDARY Percentage of Participants With an Intensive Care Unit (ICU) Stay by Day 28 |
58.2; 54.6; 46.2 | 0.5560 |
| SECONDARY Duration of Intensive Care Unit (ICU) Stay by Day 28 |
3.10; 2.62; 0.00 | 0.4845 |
| SECONDARY Time to Clinical Failure by Day 28, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal of Care (Whichever Occurs First) |
NA; NA; NA | 0.4456 |
| SECONDARY Percentage of Participants Who Died by Day 14 |
6.0; 8.5; 8.3 | 0.4336 |
| SECONDARY Percentage of Participants Who Died by Day 28 |
11.2; 14.6; 12.9 | 0.4067 |
| SECONDARY Time to Clinical Improvement, Defined as a National Early Warning Score 2 (NEWS2) Aggregate Score of ≤2 Maintained for 24 Hours |
5.5; 6.0; 6.0 | 0.3831 |
| SECONDARY Safety Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) |
87; 85; 95; 23; 23; 21 | — |
| SECONDARY Number of Participants With Clinical Laboratory Test Abnormalities by Highest NCI-CTCAE Grade Post-Baseline |
103; 105; 118; 32; 36; 40 | — |
| SECONDARY Number of Participants With Vital Sign Abnormalities at Anytime Post-Baseline |
23; 23; 21; 39; 43; 39 | — |
| SECONDARY Number of Participants by the Investigator's Interpretations of Electrocardiogram Recordings at Specified Timepoints |
56; 60; 55; 76; 66; 75 | — |
| SECONDARY Percentage of Participants Who Tested Positive for Anti-Drug Antibodies (ADAs) to MSTT1041A and UTTR1147A at Baseline and at Anytime Post-Baseline |
3.4; 2.6; 1.7; 1.6; 2.9; 0.9 | — |
| SECONDARY Serum Concentration of UTTR1147A at Specified Timepoints |
1260; 1600; 1320; 707; 674; 700 | — |
| SECONDARY Serum Concentration of MSTT1041A at Specified Timepoints |
206; 227; 210; 175; 178; 176 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
- Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300 millimetres of mercury (mmHg) or requiring supplemental oxygen to maintain SpO2 >93% or requirement for supplemental oxygen to maintain SpO2 at an acceptable level per local standard of care
Exclusion Criteria
- Pregnant or breastfeeding, or positive pregnancy test at screening
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Participating in another clinical drug trial
- Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug
- Use of Janus kinase (JAK) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening
- Have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to Day 1
- Known HIV infection with CD4 10 times the upper limit of normal (ULN) detected at screening
- History of anaplastic large-cell lymphoma or mantle-cell lymphoma
- History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
- Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ECG, laboratory assessment, or echocardiographic data
- History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment
Data sourced from ClinicalTrials.gov (NCT04386616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.