EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Epidemiological and Clinical Research Information Network; Institut National de la Santé Et de la Recherche Médicale, France

Criteria

EU SOLIDACT PLATFORM INCLUSION CRITERIA:

Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:

• GI1. ≥ 18 years of age

• GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old.

• GI3. Admitted to hospital

• GI4. Informed consent by the participant or legally authorized representative

• GI5A (SolidAct part A): Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or

• GI5B (SolidAct part B): Severe/critical disease state defined as fulfilling at least one of the following criteria:

1. SpO2<90% on room air, or

2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or

3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or

4. Need of mechanical ventilation/ECMO

*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).

NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation.

Additional inclusion criteria are given in the intervention-specific sub-protocols.

EU SOLIDACT PLATFORM EXCLUSION CRITERIA:

Participants are excluded from the study if any of the following general exclusion criteria (GE) apply:

• GE1. Anticipated transfer to another non-trial hospital within 72 hours

Additional exclusion criteria, including prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols