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 : OUTCOV Study

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 : OUTCOV Study - OUTCOV

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001723-13-FR

Enrollment

640

Registered

2020-04-08

Start date

2020-04-17

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 patients with risk factor for poor outcome

Interventions

Trade Name: PLAQUENIL 200 MG CPR Pharmaceutical Form: Tablet Trade Name: KALETRA 200MG/50MG CPR Pharmaceutical Form: Tablet INN or Proposed INN: LOPINAVIR CAS Number: 192725-17-0 Current Sponsor code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Either more than 50 years of age with at least comorbidity (hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency) OR more than 70 years of age with or without comorbidity 2) Laboratory 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 system 5) Able to understand and sign a written informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320

Exclusion criteria

Exclusion criteria: 1) Need for hospitalization 2) Patient in long term facility 3) Patient without concern confirmation of COVID-19 by laboratory test or chest CT 4) Known hypersensitivity or contra-indication to the 3 experimental treatments (Azithromycin, Hydroxychloroquine, Lopinavir/Ritonavir)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the effect of treatment on the reduction of hospitalization rate among COVID19 patients with risk factors of poor prognosis. ;Secondary Objective: To evaluate the effect of treatment on 1.Death 2.Death due to COVID 3.Need for ICU stay 4.Duration of ICU stay 5.Need of mechanical ventilation 6.Duration of mechanical ventilation 7.Time to hospitalization 8.Duration of Hospital stay 9.Duration of symptoms To evaluate the safety of the different arms To evaluate the respiratory impairment;Primary end point(s): Hospital admission rate between D0 and Day 20 ;Timepoint(s) of evaluation of this end point: DAY 20	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the effect of treatment on the reduction of hospitalization rate among COVID19 patients with risk factors of poor prognosis. ;Secondary Objective: To evaluate the effect of treatment on 1.Death 2.Death due to COVID 3.Need for ICU stay 4.Duration of ICU stay 5.Need of mechanical ventilation 6.Duration of mechanical ventilation 7.Time to hospitalization 8.Duration of Hospital stay 9.Duration of symptoms To evaluate the safety of the different arms To evaluate the respiratory impairment;Primary end point(s): Hospital admission rate between D0 and Day 20 ;Timepoint(s) of evaluation of this end point: DAY 20

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Death 2. Death due to COVID 3. Need for ICU stay 4. Duration of ICU stay 5. Need of mechanical ventilation 6. Duration of mechanical ventilation 7. Time to hospitalization 8. Duration of Hospital stay 9. Duration of symptoms Safety outcome measures between M0 and M6 : Adverse events/Serious adverse events according to Common Terminology Criteria For Adverse Event (CTCAE)/Discontinuation of experimental treatment Respiratory impairment at 6 month ;Timepoint(s) of evaluation of this end point: 1. Overall survival : D20, D60 (obtain by telephone at D20) 2. Mortality link to COVID: D20, D60 (obtain by telephone at D20) 3. Admission in ICU : D20, D60 (obtain by telephone at D20) 4. Duration of ICU stay : D20, D60 (obtain by telephone at D20) 5. Need for mechanical ventilation : D20, D60 (obtain by telephone at D20) 6. Duration of mechanical ventilation : D20, D60 (obtain by telephone at D20) 7. Time to hospitalisation : D20, D60 (obtain by telephone at D20) 8. Duration of hospitalization : D20, D60 (obtain by telephone at D20) 9. Duration of symptoms : D20, D60 (obtain by telephone at D20) Safety outcome measures between M0 and M6 Respiratory impairment at 6 month	—

Measure

Time frame

Secondary end point(s): 1. Death 2. Death due to COVID 3. Need for ICU stay 4. Duration of ICU stay 5. Need of mechanical ventilation 6. Duration of mechanical ventilation 7. Time to hospitalization 8. Duration of Hospital stay 9. Duration of symptoms Safety outcome measures between M0 and M6 : Adverse events/Serious adverse events according to Common Terminology Criteria For Adverse Event (CTCAE)/Discontinuation of experimental treatment Respiratory impairment at 6 month ;Timepoint(s) of evaluation of this end point: 1. Overall survival : D20, D60 (obtain by telephone at D20) 2. Mortality link to COVID: D20, D60 (obtain by telephone at D20) 3. Admission in ICU : D20, D60 (obtain by telephone at D20) 4. Duration of ICU stay : D20, D60 (obtain by telephone at D20) 5. Need for mechanical ventilation : D20, D60 (obtain by telephone at D20) 6. Duration of mechanical ventilation : D20, D60 (obtain by telephone at D20) 7. Time to hospitalisation : D20, D60 (obtain by telephone at D20) 8. Duration of hospitalization : D20, D60 (obtain by telephone at D20) 9. Duration of symptoms : D20, D60 (obtain by telephone at D20) Safety outcome measures between M0 and M6 Respiratory impairment at 6 month

—

Countries

France

Contacts

Public ContactClinical Research Pharmacist

Groupe Hospitalier Paris Saint Joseph

nbennasr@hpsj.fr0033144127084

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026