Table 2.
AIFA approved experimental studies in COVID-19 therapy.
| Study | Promoter | CE Single Opinion Date | Documents |
|---|---|---|---|
| A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of tocilizumab in patients with severe covid-19 pneumonia (Tocilizumab 2020-001154-22). | F.Hoffmann-La Roche Ltd | 30/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/TocilizumabDocumenti.zip |
| An open-label randomized multicenter study to evaluate the efficacy of early administration of Tocilizumab (TCZ) in patients with COVID-19 pneumonia (RCT-TCZ-COVID-19). | Local Health Unit-IRCCS of Reggio Emilia | 27/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/RCT-TCZ-COVID19documenti.zip |
| Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19). | National Cancer Institute, IRCCS, G. Pascale Foundation | 22/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/TOCIVID-19documenti.zip |
| A randomized, double-blind, placebo-controlled adaptive phase 2/3 study evaluating the efficacy and safety of sarilumab for hospitalized patients with COVID-19 (Sarilumab COVID-19). | Sanofi-aventis Recherche & Développement | 26/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/Sarilumabdocumenti.zip |
| A phase 2/3, randomized, open-label, parallel, 3-arm, multicenter study investigating the efficacy and safety of intravenous doses of emapalumab, a monoclonal anti-interferon gamma (anti-IFNγ) and anakinra antibody, a interleukin -1 receptor antagonist (IL-1), compared to the standard of care, in reducing hyperinflammation and respiratory difficulties in patients with SARSCoV-2 infection (Sobi.IMMUNO-101). | SOBI | 25/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/Sobi.IMMUNO-101documenti.zip |
| A randomized phase 3 study to evaluate the safety and antiviral activity of Remdesivir (GS-5734 ™) in participants with moderate COVID-19 treatment compared to the standard of therapy. (Study GS-US-540-5774) | Gilead Sciences, Inc | 11/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/GS-US-540-5774documenti.zip |
| A randomized phase 3 study to evaluate the safety and antiviral activity of Remdesivir (GS-5734 ™) in participants with severe COVID-19. (Study GS-US-540-5773) | Gilead Sciences, Inc | 11/03/2020 | https://www.aifa.gov.it/documents/20142/1131319/GS-US-540-5773_documenti.zip |
| A randomized controlled two-phase phase 2 trial to evaluate the efficacy, safety and tolerability of baricitinib in addition to the usual treatment in patients with pneumonia in COVID19 | Pisan University Hospital | 23/04/2020 | https://www.aifa.gov.it/documents/20142/1131319/BARCHID_documenti.zip |
| Colchicine to counteract the inflammatory response in COVID pneumonia 19 | University Hospital of Parma | 23/04/2020 | https://www.aifa.gov.it/documents/20142/1131319/CoICoviddocumenti.zip |
| Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID19: a pilot phase II single-arm study, INHIXACOVID19 | Bologna University | 23/04/2020 | https://www.aifa.gov.it/documents/20142/1131319/INHIXACOVID_documenti.zip |
AIFA: Italian Medicines Agency.