Study Details
- Type: Interventional
- Disease: Covid 19 Surveillance of positive tests
- Primary Site: Fondazione Policlinico Gemelli
- Start: February 2021
- Population: Outpatient pulmonary adults with documented positive SARS-CoV-2 test
- Duration: Ongoing
Study Description
MONET study is a Phase 3, open-label, individually randomized study in patients with documented positive SARS-CoV-2 test and mild symptoms of COVID-19, not hospitalized and recruited in Italy. This study will assess the efficacy of multiple MoAbs cocktails compared to SoC for Treatment of COVID-19 in Outpatient Adults. The study will be conducted in 42 clinical centers across Italy.
Study Design & Method
The procedure to be followed is the randomized administration of 2 different MoAbs cocktails, all intravenously over one-hour infusion. Then there will be control and monitoring of the differences that will occur in the participants of the study. The adaptive design of the study is aimed to meet the most topical needs of translational medical research programs implemented during a massive epidemic emergency due to newly emergent pathogens, such as SARS-CoV-2.
All participants will use the Healthentia app to answer simple and composite questionnaires about their health status. Each organisation will monitor any symptoms that any user/participant may appear.
42 Centers involved in the study and is planned to be executed on 750 to 2350 subjects
Estimation of the efficacy of any MoAbs in the prevention of the composite endpoint of either severe COVID-19 or hospitalization or access in an emergency department or death
