EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial
- Conditions
- Emerging Infectious DiseaseCOVID-19
- Interventions
- Drug: Placebo
- Registration Number
- NCT04891133
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator Placebo Matching placebo up to 14 days + SoC Active arm Baricitinib 4mg Baricitinib up to 14 days + SoC
- Primary Outcome Measures
Name Time Method Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A) 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)
SpO2/FiO2-ratio at day 5 (primary end point, phase 2 trials) 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
Occurrence of death within 60 days (primary end point, EU SolidAct part B) 60 days The primary outcome for phase 3 trials in EU SolidAct part B is occurrence of death within 60 days
- Secondary Outcome Measures
Name Time Method Occurrence of disease progression within 28 days (shared secondary end point for part A and B) 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
Disease state at Day 15 and Day 29 (shared secondary end point for part A and B) 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 29Time to first hospital discharge (shared secondary end point for part A and B) 90 days Time from randomization to first hospital discharge within 90 days
SpO2/FiO2-ratio at Day 3, 5 and 8 (shared secondary end point for part A and B) 8 days Respiratory dysfunction assessed by SpO2/FiO2-ratio at Day 3, 5 and 8
Occurrence of serious adverse events within 90 days (shared secondary end point for part A and B) 90 days Occurrence of serious adverse events leading to study treatment discontinuation or death
Time to sustained recovery (shared secondary end point for part A and B) 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
Time from randomization to recovery (shared secondary end point for part A and B) 90 days Time from randomization to recovery defined as no need for oxygen
Viral clearance during hospitalization (shared secondary end point for part A and B) 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
Patient related outcomes at day 90 (shared secondary end point for part A and B) 90 days The Oslo COVID-19 QLQ-PW80 subscale scores at Day 90
Trial Locations
- Locations (92)
Beaumont Hospital, Dublin
🇮🇪Dublin, Ireland
Erasme Hospital
🇧🇪Brussels, Belgium
Hôpital Bichat - Claude Bernard (ICU)
🇫🇷Paris, France
CHU de Bordeaux / Hopital Pellegrin (ID)
🇫🇷Bordeaux, France
GHRMSA Hopital Emile Muller (IM)
🇫🇷Mulhouse, France
CHU Amiens Picardie (ID)
🇫🇷Amiens, France
Louis Mourier (ID)
🇫🇷Colombes, France
Hôpital Saint-Antoine (ICU)
🇫🇷Paris, France
CHU de Bordeaux / Hopital Pellegrin (ICU)
🇫🇷Bordeaux, France
CHU François Mitterrand
🇫🇷Dijon, France
Hôpital Bichat - Claude Bernard (ID)
🇫🇷Paris, France
Technische Universität München (TUM) - Klinikum rechts der Isar
🇩🇪München, Germany
Gesundheit Nord gGmbH (GeNo)
🇩🇪Bremen, Germany
Lous Mourier (ICU)
🇫🇷Colombes, France
Azienda Opsedaliera Universitaria Mater Domini, U.O. Malattie Infettive e Tropicali
🇮🇹Catanzaro, Italy
CHU Lille - Hopital Roger Salengro -Pôle Rèanimaition
🇫🇷Lille, France
GHRMSA Hopital Emile Muller (ICU)
🇫🇷Mulhouse, France
ASST - Spedali Civili di Brescia - University of Brescia
🇮🇹Brescia, Italy
CHSJ - São João Hospital Center
🇵🇹Lisbon, Portugal
Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 2)
🇹🇷Ankara, Turkey
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Medical Unversity of Innsbruck (Joint Institute for Emergency Medicine and Critical Care)
🇦🇹Innsbruck, Austria
Medical Unversity of Innsbruck (University Hospital for Anaesthesia and Intensive Care)
🇦🇹Innsbruck, Austria
UZ Brussel
🇧🇪Brussels, Belgium
St Anne University Hospital
🇨🇿Brno, Czechia
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hopital de la Croix - Rousse - HCL (ICU)
🇫🇷Lyon, France
Hopital de la Croix - Rousse - HCL (ID)
🇫🇷Lyon, France
Hôpital Saint-Antoine (ID)
🇫🇷Paris, France
University of Debrecen (Clinic for Infectology)
🇭🇺Debrecen, Hungary
University of Szeged (Pandemic Clinics)
🇭🇺Szeged, Hungary
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
St Vincent's University Hospital
🇮🇪Dublin, Ireland
St James's Hospital, Dublin
🇮🇪Dublin, Ireland
Tallaght University Hospital
🇮🇪Dublin, Ireland
University Hospital Limerick
🇮🇪Limerick, Ireland
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
Drammen (Vestre Viken) Hospital
🇳🇴Drammen, Norway
Østfold sykehuset i Kalnes
🇳🇴Grålum, Norway
Lovisenberg Diaconal Hospital
🇳🇴Oslo, Norway
OUS Ullevål
🇳🇴Oslo, Norway
St. Olavs Hospital
🇳🇴Trondheim, Norway
Stavanger University Hospital
🇳🇴Stavanger, Norway
University Hospital North Norway
🇳🇴Tromsø, Norway
Vestfold Hospital
🇳🇴Tønsberg, Norway
CHMT - Centro Hospitalar do Médio Tejo- Hospital de Abrantes
🇵🇹Abrantes, Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra
🇵🇹Coimbra, Portugal
CHUA-Faro - Centro Hospitalar Universitário do Algarve
🇵🇹Faro, Portugal
CHLC-HCC - Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central
🇵🇹Lisboa, Portugal
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
CHLN - Centro Hospitalar Universitário Lisboa Norte
🇵🇹Lisboa, Portugal
HBA - Hospital Beatriz Ângelo
🇵🇹Loures, Portugal
University Hospital Bratislava, Kramare
🇸🇰Bratislava, Slovakia
University Hospital Martin
🇸🇰Martin, Slovakia
Nsp Trebisov, Svet Zdravia a.s.
🇸🇰Trebišov, Slovakia
Faculty Hospital Trencin
🇸🇰Trenčín, Slovakia
University Hospital Trnava
🇸🇰Trnava, Slovakia
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario de Jaen
🇪🇸Jaén, Spain
Hospital Costa del Sol
🇪🇸Marbella, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 1)
🇹🇷Ankara, Turkey
Ankara Üniversitesi Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı
🇹🇷Ankara, Turkey
İstanbul Üniversitesi İstanbul Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı
🇹🇷Istanbul, Turkey
Dokuz Eylül Üniversitesi Tıp Fakültesi Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı
🇹🇷İzmir, Turkey
Ospedale Santa Maria Annunziata, Malattie Infettive
🇮🇹Bagno A Ripoli, Italy
ATS Sardegna - PO SS Trinità, U.O.C. Malattie Infettive
🇮🇹Cagliari, Italy
ASL Frosinone - Ospedale Fabrizio Spaziani, U.O.C. Medicina Interna
🇮🇹Frosinone, Italy
Ospedale S.M. Goretti di Latina, U.O.C. Malattie Infettive
🇮🇹Latina, Italy
Ospedale Mater Salutis di Legnago, U.O.C. di Pneumologia
🇮🇹Legnano, Italy
Ospedale Mater Salutis di Legnago, U.O.S. di Malattie Infettive
🇮🇹Legnano, Italy
ASST Santi Paolo e Carlo, S.C. Malattie Infettive
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Vanvitelli, U.O.C. Malattie Infettive
🇮🇹Napoli, Italy
AOU Policlinico "P. Giaccone", U.O.C. Malattie Infettive
🇮🇹Palermo, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, U.O.C. Malattie Infettive
🇮🇹Pesaro, Italy
ASL Taranto - Ospedale Oncologico San Giuseppe Moscati, U.O.C. Pneumologia
🇮🇹Taranto, Italy
AOU Città della Salute e Scienza Presidio Molinette
🇮🇹Torino, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), S.C. Malattie Infettive
🇮🇹Trieste, Italy
IRCCS Ospedale Sacro Cuore Don Calabria, U.O.S. Malattie Infettive e Tropicali
🇮🇹Verona, Italy
Azienda Ospedaliera Universitaria Integrata di Verona, U.O.C. Malattie Infettive e Tropicali
🇮🇹Verona, Italy
Medical University of Innsbruck (University Hospital for Neurosurgery)
🇦🇹Innsbruck, Austria
Evangelismos Hospital
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Athens, Greece
University Hospital Galway
🇮🇪Galway, Ireland
Akershus Universitetssykehus
🇳🇴Lørenskog, Norway
University of Pécs
🇭🇺Pécs, Hungary
Cork University Hospital
🇮🇪Cork, Ireland
CHLO - Centro Hospitalar de Lisboa Ocidental - HEM and HSFX
🇵🇹Lisbon, Portugal
Bærum Hospital
🇳🇴Sandvika, Norway
CHU Amiens Picardie (ICU)
🇫🇷Amiens, France