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.
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.
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.
University of Verona (Coordinator)
AOU Città della Salute e Scienza, Torino
AOU Policlinico Università di Palermo
ASST Fatebenefratelli Sacco
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