NCT04365582

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

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• COVID

Interventions

Type	Name	Description
DRUG	Azithromycin	500 mg day 1 ; 250 mg/day for 4 days
DRUG	Hydroxychloroquine	200 mg x 3/day for 10 days
DRUG	Lopinavir 200Mg/Ritonavir 50Mg Tab	400/100 mg (2 tablets) x 2/day for 15 days

Timeline

• Start date: 2020-05-07
• Primary completion: 2020-12-31
• Completion: 2021-04-19
• First posted: 2020-04-28
• Last updated: 2021-04-27