European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial (EU-SolidAct)

The EU-SolidAct trial is part of EU-RESPONSE, a pan-European research project involved with rapid and coordinated investigation of new and repurposed medication to treat Covid-19 during the ongoing pandemic. EU-SolidAct is an Adaptive Platform Trial. The master protocol is developed for evaluating treatments in hospitalized patients with COVID-19, the disease caused by the SARS-CoV2 virus (coronavirus).

While the master protocol is currently designed to test medications in hospitalised patients in phase 2 and phase 3 clinical trials, it will be expanded to other interventions, trial phases and involve patients outside of hospital when necessary. The protocol is designed such that it functions as the basis of a joint European response to combat infectious agents both now and in the future.

EU-SolidAct recruited from around fifteen European countries. The trial is sponsored by Oslo University Hospital, Norway.

The EU-SolidAct trial is part of EU-RESPONSE, a pan-European research project involved with rapid and coordinated investigation of new and repurposed medication to treat Covid-19 during the ongoing pandemic. EU-SolidAct is an Adaptive Platform Trial. The master protocol is developed for evaluating treatments in hospitalized patients with COVID-19, the disease caused by the SARS-CoV2 virus (coronavirus).

While the master protocol is currently designed to test medications in hospitalised patients in phase 2 and phase 3 clinical trials, it will be expanded to other interventions, trial phases and involve patients outside of hospital when necessary. The protocol is designed such that it functions as the basis of a joint European response to combat infectious agents both now and in the future.

EU-SolidAct recruited from around fifteen European countries. The trial is sponsored by Oslo University Hospital, Norway.

• EU-SolidAct is adaptive and enables the inclusion of hospitals in Europe and beyond, regardless of the severity of epidemic waves or available resources.
• The protocol is divided into two main parts: Part A for patients with moderate disease, and part B for patients with severe to critical disease.
• The data captured ranges from a core set of outcomes to more advanced data capture. The sites can choose between 3 levels of data capture, depending on their capacity. These levels are specified in the protocol.
• New treatments arms may be added or removed adaptively as evidence on treatment efficacy emerges.