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Clinical Trials/EUCTR2021-000541-41-IE
EUCTR2021-000541-41-IEActive, not recruitingPhase 1

European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct

Oslo University Hospital0 sites2,000 target enrollmentStarted: May 5, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
2,000
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Master Protocol Number: 2.0 dated 01 November 2021:
  • •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: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
  • •GI5B: Severe/critical disease state defined as fulfilliing 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.
  • •Baricitinib specific protocol v. 2.0 dated 01 November 2021:
  • •All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B).
  • •Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
  • •GI1.=18 years of age
  • •GI2.Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old
  • •GI3.Admitted to hospital
  • •GI4.Informed consent by the participant or legally authorized representative.
  • •GI5B: 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.
  • •In addition, the following specific inclusion criterion applies to
  • •immunocompromised patients:
  • •SI-01. Immunocompromised patients are eligible only if they have
  • •elevation of 2 or more inflammatory markers above the following
  • •-Ferritin = 700 ug/l
  • •-LDH = 400 U/L
  • •-CRP =75 mg/dL
  • •Immunocompromised patients are defined as the presence of at least
  • •one of the following conditions:
  • •1. Hematological malignancy or pre-malignancy, except acute leukemia
  • •or history of lymphoma
  • •2. Organ transplant recipients, except recipients of bone marrow or
  • •solid organ transplant last 6 months, or with transplant rejection last 6
  • •3. HIV positive with CD4 count < 350 cells and on stable antiretroviral
  • •4. Primary immunodeficiency

Exclusion Criteria

  • •Master Protocol Number 2.0 dated 1 Nov 2021:
  • •Participants are excluded from the study if any of the following general exclusion criteria apply:
  • •GE1.Anticipated transfer to another non-trial hospital within 72 hours
  • •Baricitinib specific protocol v. 2.0 dated 1 Nov 2021:
  • •GE1. Anticipated transfer to another non-trial hospital within 72 hours.
  • •In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:
  • •SE-01. Patients receiving Janus kinase (JAK) inhibitors (including
  • •baricitinib) for any indication at screening.
  • •SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening.
  • •Note: Tocilizumab as rescue therapy will be allowed in patients with
  • •clinical progression after inclusion, see section 6.8 concomitant
  • •medication. If tocilizumab or other immunosuppressive rescue therapy is
  • •started, IMP should be discontinued.
  • •SE-21. Patients with recent changes in immunosuppressive therapy
  • •that could interfere with the potential effect of baricitinib.
  • •- Recipients of bone marrow transplant or solid organ transplant last 6
  • •months, or with transplant rejection last 6 months, should not be
  • •- Organ transplant recipients receiving triple immunosuppression can
  • •only be included if the anti-metabolite (mycophenolic acid or mTOR
  • •inhibitor) has been temporarily discontinued per clinical practice. IMP
  • •should be discontinued once triple immunosuppression is restarted.
  • •SE-22. Any medical condition that in the opinion of the investigator
  • •poses an inacceptable risk of serious infection or aggravation of the
  • •medical condition by participating in the trial.
  • •Note: Patients with acute leukemia or history of lymphoma should not be
  • •included. Cancer patients under active treatment, HIV positive
  • •individuals with detectable HIV-RNA, or other patient group associated
  • •with high risk of serious infection or aggravation of the medical
  • •condition should only be included if, in the judgement of the
  • •investigator, the potential benefit outweighs the potential risk.
  • •SE-03. Have received dexamethasone 6 mg daily (or alternative
  • •regimens with equivalent of corticosteroids) for more than 4 days prior
  • •to screening as part of SoC for severe/critical COVID-19
  • •SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days.
  • •SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.
  • •SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
  • •o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
  • •SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
  • •SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
  • •SE-10. Suspected serious, active bacterial, fungal, viral, or other
  • •infection (besides COVID-19) that in the opinion of the investigator
  • •could constitute a risk when taking investigational product.
  • •SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonar

Investigators

Sponsor
Oslo University Hospital

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