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EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

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ClinicalTrials.gov Identifier: NCT04891133
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : April 22, 2022
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
Marius Trøseid, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Emerging Infectious Disease Drug: Baricitinib Drug: Placebo Phase 2 Phase 3

Detailed Description:

There is an urgent need for developing an adaptive pan-European research platform for rapid and coordinated investigation of new candidate drugs during ongoing pandemics. EU-SolidAct is an Adaptive Platform Trial master protocol developed for evaluating drug interventions in hospitalized patients with COVID-19. While this master protocol is developed for therapeutic interventions in hospitalized patients, it could also form the basis for trial protocols on other interventions and/or in non-hospitalized populations. The protocol is additionally developed to facilitate a joint European response to the challenge of evaluating interventions during future epidemics. The described disease states and endpoints may need to be adapted to the epidemic in question.

EU-SolidAct is a European, multicentre, randomized, parallel, phase 2 and 3 platform trial on drug interventions, both new and repurposed, single or in combination, in hospitalized adult patients with moderate or severe COVID-19, as defined by the WHO Working Group on the Clinical Characterisation and Management of COVID-191. Participants with moderate disease (WHO score 4-5) will be eligible for EU-SolidAct Part A, whereas participants with severe/critical disease (WHO score 6-9) will be eligible for EU-SolidAct Part B. This might include participants progressing from Part A.

In Part A of phase 3 confirmatory trials, the primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression, from moderate disease to severe/critical disease or death within 14 days. In Part B, the primary objective is to determine the effect of therapeutic interventions on occurrence of death within 60 days.

In phase 2 the default objective for both parts is to explore the effect of the therapeutic intervention on respiratory dysfunction at day 5. Other objectives, e.g. effect on virological outcomes may be considered based on the treatment mode of action.

In phase 3 trials, both superiority and non-inferiority hypotheses may be evaluated. In phase 2 trials, only superiority hypotheses will be evaluated. In addition to single treatments, combination of treatments could also be assessed through factorial design. EU-SolidAct is designed to be adaptive and to enable inclusion of hospitals in Europe and beyond, regardless of epidemic waves and available resources. This requires the master protocol to be modular, ranging from a core set of outcomes to more advanced data capture. Hospitals will access the study on different pre-set levels, ranging from a core set of clinical endpoints and safety measures, to a more advanced level with biobanking and possibilities for add-on studies

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Corresponding placebo tablets
Primary Purpose: Treatment
Official Title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Baricitinib

Arm Intervention/treatment
Experimental: Active arm
4mg Baricitinib up to 14 days + SoC
Drug: Baricitinib
4 mg baricitinib (2 tablets of 2 mg) once daily
Other Name: Olumiant

Placebo Comparator: Comparator
Matching placebo up to 14 days + SoC
Drug: Placebo
4 mg placebo (2 tablets of 2 mg) once daily




Primary Outcome Measures :
  1. Occurrence of death within 60 days (primary end point, EU SolidAct part B) [ Time Frame: 60 days ]
    The primary outcome for phase 3 trials in EU SolidAct part B is occurrence of death within 60 days

  2. Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A) [ Time Frame: 14 days ]
    The primary outcome for phase 3 trials in EU SolidAct part A is occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10)

  3. SpO2/FiO2-ratio at day 5 (primary end point, phase 2 trials) [ Time Frame: 5 days ]
    In phase 2 exploratory trials, the default primary objective for both part A and B is to explore the effect of the intervention on respiratory dysfunction assessed by SpO2/FiO2-ratio at day 5


Secondary Outcome Measures :
  1. Occurrence of disease progression within 28 days (shared secondary end point for part A and B) [ Time Frame: 28 days ]
    Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical/death (WHO score 6-10) or from severe/critical (WHO score 6-9) to death

  2. Time to sustained recovery (shared secondary end point for part A and B) [ Time Frame: 90 days ]
    Time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and at home for 14 consecutive days within 90 days

  3. Time to first hospital discharge (shared secondary end point for part A and B) [ Time Frame: 90 days ]
    Time from randomization to first hospital discharge within 90 days

  4. Disease state at Day 15 and Day 29 (shared secondary end point for part A and B) [ Time Frame: 28 days ]

    Disease state on a 5-point scale defined as:

    1. Mild (WHO score 1-3) or better,
    2. Moderate (WHO score 4-5),
    3. Severe (WHO score 6),
    4. Critical (WHO score 7-9) or
    5. Death at Day 15 and 29

  5. Time from randomization to recovery (shared secondary end point for part A and B) [ Time Frame: 90 days ]
    Time from randomization to recovery defined as no need for oxygen

  6. SpO2/FiO2-ratio at Day 3, 5 and 8 (shared secondary end point for part A and B) [ Time Frame: 8 days ]
    Respiratory dysfunction assessed by SpO2/FiO2-ratio at Day 3, 5 and 8

  7. Viral clearance during hospitalization (shared secondary end point for part A and B) [ Time Frame: Days 1, 3, 5, 8 and 15 ]
    Viral clearance as assessed by SARS-CoV-2 PCR in naso/oropharyngeal specimens collected at Days 1, 3, 5, 8 and 15 (± 1 day, except baseline) if still hospitalized

  8. Occurrence of serious adverse events within 90 days (shared secondary end point for part A and B) [ Time Frame: 90 days ]
    Occurrence of serious adverse events leading to study treatment discontinuation or death

  9. Patient related outcomes at day 90 (shared secondary end point for part A and B) [ Time Frame: 90 days ]
    The Oslo COVID-19 QLQ-PW80 subscale scores at Day 90


Other Outcome Measures:
  1. Changes in C-reactive protein from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  2. Changes in Ferritin from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  3. Changes in Lactate dehydrogenase from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  4. Changes in D-dimer from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  5. Changes in procalcitonin from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  6. Changes in neutrophils from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  7. Changes in lymphocytes from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized

  8. Changes in White Blood Cell Count from baseline [ Time Frame: Days 1, 3, 5, 8, 15 and 22 ]
    Analyzed in blood samples collected at Days 1, 3, 5, 8, 15 and 22 (± 1 day) if still hospitalized



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 14 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04891133


Contacts
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Contact: Marius Trøseid, MD PhD +4792440240 marius.troseid@medisin.uio.no
Contact: Inge C Olsen, PhD +4741459597 inge.christoffer.olsen@gmail.com

Locations
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Sponsors and Collaborators
Oslo University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Epidemiological and Clinical Research Information Network
Investigators
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Study Chair: Domique Costagliola, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Jose R Arribas, MD PhD Hospital Universario La Paz, Madrid
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marius Trøseid, Associated professor, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04891133    
Other Study ID Numbers: EU SolidAct
2021-000541-41 ( EudraCT Number )
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants. Anonymized data will be made publicly available using a data repository, including any programming code used to produce the trial results. De-identified data will be made available upon request and evaluation of the requestee's ability and willingness to maintain the integrity and privacy of the trial participants. Further details of data sharing will be given in a separate data sharing plan.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Communicable Diseases, Emerging
Disease Attributes
Pathologic Processes