EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

Sponsor
Oslo University Hospital
Study ID
NCT04891133
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    4 mg baricitinib (2 tablets of 2 mg) once daily
  • Placebo — DRUG
    4 mg placebo (2 tablets of 2 mg) once daily

Study Details

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.

Key Dates

Start date
Jun 3, 2021
Status verified
Feb 2023
Primary completion
Dec 15, 2022
Completion
Jan 23, 2023

Study Design

Enrollment
290 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active arm
    4mg Baricitinib up to 14 days + SoC
  • Placebo Comparator: Comparator
    Matching placebo up to 14 days + SoC

Primary Outcome Measure

Occurrence of death within 60 days (primary end point, EU SolidAct part B) [ Time Frame: 60 days ]

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