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

Fondation Hôpital Saint-Joseph

Status and phase: Withdrawn; Phase 3

Conditions: COVID

Treatments: Drug: Hydroxychloroquine; Drug: Azithromycin; Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT04365582

OUTCOV

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 4 patient groups

Azithromycin

Experimental group

Description:

Azithromycin

Treatment:

Drug: Azithromycin

Hydroxychlororquine

Experimental group

Description:

Hydroxychlororquine

Treatment:

Drug: Hydroxychloroquine

Lopinavir/Ritonavir

Experimental group

Description:

Lopinavir/Ritonavir

Treatment:

Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

standards of care

No Intervention group

Description:

SoC