Abstract
To assess whether high-dose coronavirus disease (COVID-19) convalescent plasma (CCP) transfusion may benefit patients with severe COVID-19, we conducted a multicenter randomized trial in Brazil. Patients with severe COVID-19 who were within 10 days of initial symptom onset were eligible. Patients in the CCP group received 3 daily doses of CCP (600 mL/d) in addition to standard treatment; control patients received standard treatment only. Primary outcomes were death rates at days 30 and 60 of study randomization. Secondary outcomes were ventilator-free days and hospital-free days. We enrolled 107 patients: 36 CCP and 71 control. At day 30, death rates were 22% for CCP and 25% for the control group; at day 60, rates were 31% for CCP and 35% for control. Needs for invasive mechanical ventilation and durations of hospital stay were similar between groups. We conclude that high-dose CCP transfused within 10 days of symptom onset provided no benefit for patients with severe COVID-19.
Highlights
Clinical research is essential for an effective public health response during an emerging infectious outbreak.[1,2,3]
Reliable management conclusions require reproducible and widely accepted metrics to describe the emerging threat—to define the natural history, to understand the spread and consequences for health-care systems, and to evaluate the effect of interventions that could modify the clinical course. Because these metrics are chosen rapidly and defined and measured differently from one study to the data sharing across studies could be facilitated if investigators agree to collect data for a set of common outcome measures
The initiative was led by the Clinical Characterisation and Management Working Group established by WHO as a component of the research and development roadmap process in response to COVID-19
Summary
WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection*. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19 This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs
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