Background
In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.
Methods
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and
ClinicalTrials.gov
(
NCT04381936
).
Findings
Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57%
vs
50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35%
vs
42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001).
Interpretation
In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.
Funding
UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
The impact of COVID-19 on conducting research is far-reaching, especially for those scholars working for or alongside communities. As the pandemic continues to create and exacerbate many of the issues that communities at the margins faced pre-pandemic, such as health disparities and access to resources, it also creates particular difficulties in collaborative, co-developed participatory research and scholar-activism. These forms of community engagement require the commitment of researchers to look beyond the purview of the racialized capitalist and neoliberal structures and institutions that tend to limit the scope of our research and engagement. Both the presence of the researcher within the community as well as deep community trust in the researcher is required in order to identify and prioritize local, often counter-hegemonic forms of knowledge production, resources, and support networks. The pandemic and similar conditions of crises has likely limited opportunities for building long-term, productive relationships of mutual trust and reciprocity needed for PAR while communities refocus on meeting basic needs. The pandemic has now not only exacerbated existing disparities and made the need for engaged, critical and co-creative partnerships even greater, it has also abruptly halted opportunities for partnerships to occur, and further constrained funds to support communities partnering with researchers. In this paper we highlight accomplishments and discuss the many challenges that arise as participatory action researchers are displaced from the field and classroom, such as funding obstacles and working remotely. An analysis of experiences of the displacement of the scholar exposes the conflicts of conducting PAR during crises within a state of academic capitalism. These experiences are drawn from our work conducting PAR during COVID-19 around the globe, both in urban and rural settings, and during different stages of engagement. From these findings the case is made for mutual learning from peer-experiences and institutional support for PAR. As future crises are expected, increased digital resources and infrastructure, academic flexibility and greater consideration of PAR, increased funding for PAR, and dedicated institutional support programs for PAR are needed.
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