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.
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
Other Name: Lopinavir/Ritonavir
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.
Jean-Marc Naccache, MD, Principal Investigator
Groupe Hospitalier Paris Saint Joseph