EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial (NCT04891133) | Clinical Trial Compass
TerminatedPhase 2/3
EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial
Stopped: The trial was stopped prematurely due to external evidence that arose during the study period showing that the IMP, baricitinib, was not effective in the primary study population.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. SpO2\<90% on room air, or
. SpO2 90-94% with a downwards trend and/or signs of respiratory distress\*, or
. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
. Need of mechanical ventilation/ECMO
. Hematological malignancy or pre-malignancy, except acute leukemia or history of lymphoma
. Organ transplant recipients, except recipients of bone marrow or solid organ transplant last 6 months, or with transplant rejection last 6 months
. HIV positive with CD4 count \< 350 cells and on stable antiretroviral therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of death within 60 days (primary end point, EU SolidAct part B)
Timeframe: 60 days
2
Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A)
Timeframe: 14 days
3
SpO2/FiO2-ratio at day 5 (primary end point, phase 2 trials)