Aims and hypotheses
The primary hypothesis of the meta-trial is that inhaled nebulised UFH in hospitalised patients with COVID-19 who do not require immediate invasive mechanical ventilation, significantly reduces rates of intubation (or death, for patients who died before intubation) at day 28, compared to standard care alone. We also hypothesise that treatment with inhaled nebulised UFH of hospitalised patients with COVID-19 reduces the risk of death, reduces the risk of clinical worsening, and improves oxygenation.
The collective aim of the study is to reach a conclusion about the efficacy of inhaled UFH in COVID-19 as quickly as possible by pooling information from multiple clinical trials not originally configured as a network, and therefore with different treatment protocols, control conditions and primary outcomes. [6]