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

Fondation Hôpital Saint-Joseph

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

COVID

Interventions

AzithromycinDRUG

500 mg day 1 ; 250 mg/day for 4 days

HydroxychloroquineDRUG

200 mg x 3/day for 10 days

Lopinavir 200Mg/Ritonavir 50Mg TabDRUG

400/100 mg (2 tablets) x 2/day for 15 days

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Either patients over 50 years of age with at least one comorbidity (hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency) OR patients over 70 years of age with or without comorbidity 2. Laboratory (PCR-) proved infection by COVID-19 or radiological sign highly suggestive of COVID-19 3. Respiratory symptoms (cough, chest discomfort, dyspnea) 4. Affiliation to the social security network 5. Able to understand and sign a written informed consent form Exclusion Criteria: 1. Need for hospitalization according to updated French guidelines (ministère de la santé\_04/04/2020) 2. Patient in long-term care facility 3. Patient without concern confirmation of COVID-19 by laboratory (PCR swab) test or chest CT 4. Known hypersensitivity or contra-indication to the 3 experimental treatments (azithromycin, hydroxychloroquine, lopinavir/ritonavir). 5. Any reason making follow up of the patient impossible during the study period.

Outcomes

Primary Outcomes

Hospital admission

Hospitalization at D20

Time frame: Day 20

Secondary Outcomes

Effect of treatment on Death at D20

This outcome corresponds to the number of patients who died on day 20.

Time frame: Day 20

Effect of treatment on Death at D60

This outcome corresponds to the number of patients who died on day 60.

Time frame: Day 60

Effect of treatment on Death due to COVID at D20

This outcome corresponds to the number of patients who died due to COVID on day 20.

Time frame: Day 20

Effect of treatment on Death due to COVID at D60

This outcome corresponds to the number of patients who died due to COVID on day 60.

Time frame: Day 60

Effect of treatment on need for ICU stay at D20

This outcome corresponds to the number of participants who need ICU stay at day 20.

Time frame: Day 20

Effect of treatment on need for ICU stay at D60

This outcome corresponds to the number of participants who need ICU stay at day 60.

Time frame: Day 60

Effect of treatment on duration of ICU stay at D20

This outcome evaluates the duration of patient's ICU stay at day 20.

Time frame: Day 20

Data from ClinicalTrials.gov

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