Treatment trial for hospitalized patients with pneumonia caused by COVID-19

Study ID: KPL-301-C203

Study of mavrilimumab in patients hospitalized with severe COVID-19 pneumonia and hyperinflammation

Researchers seek to determine if the experimental medication mavrilimumab, a monoclonal antibody, can help patients being hospitalized due to pneumonia and hyperinflammation caused by COVID-19.

Cohort 1 includes non-intubated, hospitalized participants who require supplemental oxygen.

Cohort 2 includes hospitalized participants for whom mechanical ventilation was recently initiated.

Within each cohort, patients are randomized to receive either one of two dosage levels of mavrilimumab or to receive a placebo. Patients’ results are then followed for three months.

This interventional, randomized, double-blind, placebo-controlled study encompasses two development phases (phases II and III).

Phase II is evaluating the efficacy and safety of two dose levels of mavrilimumab relative to placebo (standard of care) in participants who have tested positive for SARS-CoV-2 and have X-ray/CT evidence of bilateral pneumonia, active or recent fever, and lab results indicating hyperinflammation. The phase III portion is intended to confirm phase II efficacy and safety findings. In both phases, participants are enrolled into two cohorts:

  • Cohort 1 includes non-intubated, hospitalized participants who require supplemental oxygen to maintain oxygen saturation (SpO2) ≥ 92% (i.e., non-ventilated patients)
  • Cohort 2 includes hospitalized participants for whom mechanical ventilation was recently initiated (i.e., ventilated patients).

Following screening, enrolled participants in each cohort are then randomized 1:1:1 to receive one of two mavrilimumab dose levels — 6 mg/kg or 10 mg/kg as a single IV infusion on day 1 — or a placebo. Participants undergo primary study assessments through day 29 and are followed for safety through day 90.

Inclusion Snapshot

Must have been diagnosed with COVID-19, are being hospitalized, and have X-ray/CT evidence of bilateral pneumonia, active or recent fever, and lab results indicating hyperinflammation. Other inclusion/exclusion criteria apply.

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)

Study Locations