Clinical trial NCT04365582: OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID
Keywords: COVID
outpatient
ambulatory
prognosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital admission
timeFrame: Day 20
Secondary outcomes:
measure: Effect of treatment on Death at D20
timeFrame: Day 20
measure: Effect of treatment on Death at D60
timeFrame: Day 60
measure: Effect of treatment on Death due to COVID at D20
timeFrame: Day 20
measure: Effect of treatment on Death due to COVID at D60
timeFrame: Day 60
measure: Effect of treatment on need for ICU stay at D20
timeFrame: Day 20
measure: Effect of treatment on need for ICU stay at D60
timeFrame: Day 60
measure: Effect of treatment on duration of ICU stay at D20
timeFrame: Day 20
measure: Effect of treatment on duration of ICU stay at D60
timeFrame: Day 60
measure: Effect of treatment on need of mechanical ventilation at D20
timeFrame: Day 20
measure: Effect of treatment on need of mechanical ventilation at D60
timeFrame: Day 60
measure: Effect of treatment on duration of mechanical ventilation at D20
timeFrame: Day 20
measure: Effect of treatment on duration of mechanical ventilation at D60
timeFrame: Day 60
measure: Effect of treatment on time to hospitalization at D20
timeFrame: Day 20
measure: Effect of treatment on time to hospitalization at D60
timeFrame: Day 60
measure: Effect of treatment on Duration of Hospital stay et D20
timeFrame: Day 20
measure: Effect of treatment on Duration of Hospital stay et D60
timeFrame: Day 60
measure: Effect of treatment on Duration of symptoms at D20
timeFrame: Day 20
measure: Effect of treatment on Duration of symptoms at D60
timeFrame: Day 60
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Month 6
Other outcomes:
measure: Effect of treatment on chest radiological features
timeFrame: Month 6
measure: Effect of treatment on respiratory capacity
timeFrame: Month 6
measure: Cost consequence analysis
timeFrame: Month 6
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Jean-Marc Naccache, MD
role: PRINCIPAL_INVESTIGATOR
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