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

AbstractObjectivesThe 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-19versus control group within 28 days. Secondary objectives are:To assess the reduction in Intensive Care Unit (ICU) admission in patients treated with IFN- βversus control group within 28 days of randomizationTo assess the reduction in number of deaths in IFN- β compared to control group (day 28)To evaluate the increase in proportion of participants returning to negative SARS-CoV-2 RT-PCR in IFN- β -treatedversus control group at Day 14 and Day 28To assess the increase in SARS-CoV-2-specific binding antibody titers in IFN- β compared to control group (day 28)To assess the safety of IFN- β -treated patientsversus control groupTrial designRandomized, 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-treatedversus control patients). Randomization will be stratified by gender. Stratified randomization will balance the presence of male and female in both study arms.ParticipantsMale and female adults aged 65 years or older with newly diagnosed SARS-CoV-2 infection and mild COVID-19 symptoms are eligible for the study. The trial is being conducted in Rome.Participants will be either hospitalized or home isolated. A group ...
Source: Trials - Category: Research Source Type: clinical trials