OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome — OUTCOV  

COVID Clinical Trial

Official title: A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization

Status Withdrawn

Clinical Trial Summary

COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

Clinical Trial Description

The investigators make the hypothesis that an early outpatient treatment of COVID among patient with respiratory symptoms and risk factors for poor outcome can improve the prognosis of these patient and decrease the need for hospital admission. Our study is an open label randomized clinical trial comparing 4 arms of treatment: Standards of Care (SoC) alone versus SoC + Azithromycine versus SoC + Hydroxychloroquine vs Soc + Lopinavir/Ritonavir. Our involved population is patients more than 50 years of age with comorbidity or patients more than 70 years of age. Our primary objective is to evaluate the efficacy of early outpatient treatment compared to standard of care in patients COVID-19 with risk factors for poor outcome. The criteria is hospital admission at Day 20 and the hospital admission rate will be compared between groups by a Chi² test or a Fisher's exact test. ;

Related Conditions & MeSH terms

• COVID

• NCT number: NCT04365582
• Study type: Interventional
• Source: Groupe Hospitalier Paris Saint Joseph
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 7, 2020
• Completion date: April 19, 2021