Setting Research Priorities for Resource-Limited Settings in Times of Great Uncertainty: Where to Begin with COVID-19 Global Clinical Epidemiology? (preprint)

In rapidly evolving global situations such as the COVID-19 pandemic, research needs to incorporate the realities of different global contexts. Identifying knowledge gaps and setting research priorities in different global contexts helps to effectively direct resources and scientific efforts towards the most pressing needs, including relevant public health interventions to tackle the direct and indirect impact of the pandemic. Collaborative international research initiatives such as the COVID-19 Clinical Research Coalition are necessary to confront both the current pandemic and prepare for future outbreaks. As evidenced by this Clinical Epidemiology Working Group (WG), the COVID-19 pandemic has emphasized the importance of global communication to optimize evidence-based thinking and collaboration. We present here a list of prioritized research questions in clinical epidemiology that aims to streamline COVID-19 research priority areas for low-resource settings.

Effectiveness of Rosuvastatin plus Colchicine, Emtricitabine/Tenofovir and a combination of them in Hospitalized Patients with SARS Covid-19 (preprint)

ABSTRACT BACKGROUND The effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir, and of their combined use in hospitalized patients with coronavirus disease 2019 (Covid-19) pneumonia is unclear. METHODS In each hospital, hospitalized adults with Covid-19 pneumonia, were randomly assigned, in a 1:1 ratio, to receive: a) standard of care; or b) emtricitabine/tenofovir; or c) colchicine + rosuvastatin; or d) emtricitabine/tenofovir + colchicine + rosuvastatin. The primary outcome was all-cause mortality within the first 28 days after randomization. Severe adverse events (SAE) were those with a high probability of being treatment-related. RESULTS 633 patients were randomized in 6 hospitals in Bogota, Colombia. Overall, 98% of the patients received glucocorticoids during hospitalization. The cumulative incidence of death through day 28 was 10.7% in the emtricitabine/tenofovir + colchicine + rosuvastatin arm, 14.4% in the colchicine + rosuvastatin arm, 13.8% in the emtricitabine/tenofovir arm, and 17.4% in the standard of care arm, with adjusted risk differences (aRD) against the standard treatment of -0.07 (95% confidence interval [CI], -0.17 to 0.04), aRD -0.03 (95%CI: -0.11 to 0.05) and aRD: -0.05 (95%CI: -0.15 to 0.05), respectively. Need for invasive mechanical ventilation was lower in the emtricitabine/tenofovir + colchicine + rosuvastatin arm compared to the standard treatment arm, aRD: -0.06 (95%CI: -0.11 to -0,01), but no differences were found between the other comparisons. SAE occurred in 3 patients distributed in the 3 treatment arms. CONCLUSIONS Among patients hospitalized with moderate and severe SARS Covid-19, the use of the emtricitabine/tenofovir + colchicine + rosuvastatin combination emerges as a treatment alternative. ClinicalTrials.gov number: NCT04359095