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

• Status: Withdrawn
• Trial end date: 2021-04-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Hospitalier Paris Saint Joseph
• Treatments: Azithromycin; Hydroxychloroquine; Lopinavir; Ritonavir

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.