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

NCT04365582 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Jean-Marc Naccache, MD · Fondation Hôpital Saint-Joseph

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2020-12-31
Completion
2021-04-19

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365582 on ClinicalTrials.gov