The primary objective of the study is to demonstrate the efficacy of low-dose IFN-β in reducing the risk of SARS-CoV-2 recently infected elderly patients to progress towards severe COVID-19 versus control group within 28 days. Secondary objectives are: 1) To assess the reduction in Intensive Care Unit (ICU) admission in patients treated with IFN-β versus control group within 28 days of randomization 2) To assess the reduction in number of deaths in IFN- β compared to control group (day 28) 3) To evaluate the increase in proportion of participants returning to negative SARS-CoV-2 RT-PCR in IFN-β -treated versus control group at Day 14 and Day 28 4) To assess the increase in SARS-CoV-2-specific binding antibody titers in IFN-β compared to control group (day 28) 5) To assess the safety of IFN-β -treated patients versus control group TRIAL DESIGN: Randomized, Open-Label, Controlled, Superiority Phase II Study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned to one of the two treatment groups in a ratio 2:1 (IFN-treated versus control patients). Randomization will be stratified by gender. Stratified randomization will balance the presence of male and female in both study arms.

Antiviral and immunomodulatory interferon-beta in high-risk COVID-19 patients. A structured summary of a study protocol for a randomised controlled trial / Aricò, Eleonora; Castiello, Luciano; Bracci, Laura; Urbani, Francesca; Lombardo, Flavia; Bacigalupo, Ilaria; Ancidoni, Antonio; Vanacore, Nicola; Falcione, Alessandro; Reggiani, Chiara; Dutti, Giovanni Marco; Maglie, Maria Grazia; Papa, Ombretta; Bartoletti, Pier Luigi; Ozzella, Giuseppina; Bevilacqua, Nazario; Nicastri, Emanuele; Belardelli, Filippo; Sconocchia, Giuseppe. - In: TRIALS. - ISSN 1745-6215. - 22:1(2021), pp. 1-4. [10.1186/s13063-021-05367-6]

Antiviral and immunomodulatory interferon-beta in high-risk COVID-19 patients. A structured summary of a study protocol for a randomised controlled trial

Ancidoni, Antonio;Vanacore, Nicola;Falcione, Alessandro;Dutti, Giovanni Marco;Papa, Ombretta;Ozzella, Giuseppina;Nicastri, Emanuele;
2021

Abstract

The primary objective of the study is to demonstrate the efficacy of low-dose IFN-β in reducing the risk of SARS-CoV-2 recently infected elderly patients to progress towards severe COVID-19 versus control group within 28 days. Secondary objectives are: 1) To assess the reduction in Intensive Care Unit (ICU) admission in patients treated with IFN-β versus control group within 28 days of randomization 2) To assess the reduction in number of deaths in IFN- β compared to control group (day 28) 3) To evaluate the increase in proportion of participants returning to negative SARS-CoV-2 RT-PCR in IFN-β -treated versus control group at Day 14 and Day 28 4) To assess the increase in SARS-CoV-2-specific binding antibody titers in IFN-β compared to control group (day 28) 5) To assess the safety of IFN-β -treated patients versus control group TRIAL DESIGN: Randomized, Open-Label, Controlled, Superiority Phase II Study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned to one of the two treatment groups in a ratio 2:1 (IFN-treated versus control patients). Randomization will be stratified by gender. Stratified randomization will balance the presence of male and female in both study arms.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1567828
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