SOLIDARITY-Italy

Start Date

April 2020

Duration

18 months

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Title: An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are receiving the local standard of care.


Design: Adaptive, multiarm, controlled randomized clinical trial.


Registration Number: EudraCT Number: 2020-001366-11


Primary Objective: to provide reliable estimates about any effects of the anti-viral treatments considered in the study on in-hospital mortality in moderate and in severe COVID-19.


Secondary Objective(s): 

  • to assess any effects of anti-viral treatments on hospitalisation length, need for ventilation or for transfer to intensive care

  • to identify any serious adverse reactions.

Originally, hydroxychloroquine, interferon (β1a), lopinavir/ritonavir and Remdesivir were selected as study drugs. After interim analysis, the protocol was amended and three study drugs originally selected (hydroxychloroquine, interferon (β1a), lopinavir/ritonavir) were stopped due to futility. 

The screening of several molecules is still ongoing to identify new possible study drugs

.

Interested in collaboration? Contact: Giulia Ederle, giulia.ederle@univr.it


Publications: PMID: 33264556

Partners

University of Verona (Coordinator)
AOU Città della Salute e Scienza, Torino,
AOU Policlinico Università di Palermo,
ASL Pescara,
ASST Cremona,
ASST Fatebenefratelli Sacco,
ASST Monza,
ASST Santi Paolo e Carlo, Milano,
ASST Valtellina e Alto Lario,
AULSS 9 Scaligera,
Ospedale G. Fracastoro - San Bonifacio (VR),
AULSS 9, Distretto 4 - Villafranca (VR),
Azienda Ospedaliera Ospedali Riuniti Marche Nord,
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy,
Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore,
INMI Lazzaro Spallanzani ,
Ospedale Cardinal Massaia, Asti,
Ospedale Goretti, Latina, Ospedale Policlinico San Martino,
Policlinico Univeristario Mater Domini Catanzaro,
Policlinico di S. Orsola, Bologna,
Spedali Civili di Brescia,
Università della Campania,
Università di Bologna,
Università di Milano

ID-CARE


  • Evelina Tacconelli

  • Maria Diletta Pezzani

  • Pasquale De Nardo