A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: MSTT1041A; MSTT1041A-matched Placebo; UTTR1147A; UTTR1147A-matched Placebo
Intervention description: Participants received one intravenous (IV) infusion of MSTT1041A 700 milligrams (mg) on Day 1. A second IV dose of MSTT1041A 350 mg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen.; Participants received up to 2 intravenous infusions of MSTT1041A-matched placebo.; Participants received one intravenous (IV) infusion of UTTR1147A 90 micrograms/kilogram body weight (μg/kg) on Day 1. A second IV dose of UTTR1147A 90 μg/kg was given on Day 15 if the participant remained hospitalized with a requirement for supplemental oxygen.; Participants received up to 2 intravenous infusions of UTTR1147A-matched placebo.
Intervention MeSH terms: Astegolimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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 <200 cells/microlitre (uL) or <14% of all lymphocytes

          -  ALT or AST >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