MedTrace Logo

EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

NCT04891133 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-02-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Baricitinib

4 mg baricitinib (2 tablets of 2 mg) once daily

DRUG

Placebo

4 mg placebo (2 tablets of 2 mg) once daily

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Epidemiological and Clinical Research Information Network

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Domique Costagliola, PhD · Institut National de la Santé Et de la Recherche Médicale, France

  • Jose R Arribas, MD PhD · Hospital Universario La Paz, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-12-15
Completion
2023-01-23
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Portugal
  • Slovakia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891133 on ClinicalTrials.gov