Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
Status:
Completed
Trial end date:
2020-06-05
Target enrollment:
Participant gender:
Summary
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This
high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS),
offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly
used to treat CRS can be used to reduce COVID-19 mortality. Retrospective analysis of severe
to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of
patients had rapid resolution (i.e., within 24-72 hours following administration) of both
clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a
single tocilizumab dose.
Hypotheses:
1. Tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of
COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk
factors for clinical decompensation, intensive care utilization, and death.
2. Low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence
of COVID-19 pneumonitis in hospitalized, non-critically ill patients with and without
clinical risk factors for clinical decompensation, intensive care utilization, and
death.
Objectives:
1. To establish proof of concept that tocilizumab is effective in decreasing signs,
symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized,
non-critically ill patients with clinical risk factors for clinical decompensation,
intensive care utilization, and death, as determined by the clinical outcome of
resolution of fever and the biochemical outcome measures of time to CRP normalization
for the individual patient and the rate of patients whose CRP normalize.
2. To establish proof of concept that low-dose tocilizumab is effective in decreasing
signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized,
non-critically ill patients without clinical risk factors for clinical decompensation,
intensive care utilization, and death, as determined by the clinical outcome of
resolution of fever and the biochemical outcome measures of time to CRP normalization
for the individual patient and the rate of patients whose CRP normalize.