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

NCT04365582 | Withdrawn Phase 3 DMC

• 1 other identifier: OUTCOV
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

COVID

Keywords

COVID; outpatient; ambulatory; prognosis

Outcome Measures

Primary Outcomes (1)

• Hospital admission

  Hospitalization at D20

  Day 20

Secondary Outcomes (19)

• Effect of treatment on Death at D20

  Day 20

• Effect of treatment on Death at D60

  Day 60

• Effect of treatment on Death due to COVID at D20

  Day 20

• Effect of treatment on Death due to COVID at D60

  Day 60

• Effect of treatment on need for ICU stay at D20

  Day 20

Other Outcomes (3)

• Effect of treatment on chest radiological features

  Month 6

• Effect of treatment on respiratory capacity

  Month 6

• Cost consequence analysis

  Month 6

Study Arms (4)

Azithromycin

EXPERIMENTAL

Azithromycin

Drug: Azithromycin

Hydroxychlororquine

EXPERIMENTAL

Hydroxychlororquine

Drug: Hydroxychloroquine

Lopinavir/Ritonavir

EXPERIMENTAL

Lopinavir/Ritonavir

Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

standards of care

NO INTERVENTION

SoC

Interventions

Azithromycin DRUG

500 mg day 1 ; 250 mg/day for 4 days

Azithromycin

Hydroxychloroquine DRUG

200 mg x 3/day for 10 days

Hydroxychlororquine

Lopinavir 200Mg/Ritonavir 50Mg Tab DRUG

400/100 mg (2 tablets) x 2/day for 15 days

Also known as: Lopinavir/Ritonavir

Lopinavir/Ritonavir

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Laboratory (PCR-) proved infection by COVID-19 or radiological sign highly suggestive of COVID-19
• Respiratory symptoms (cough, chest discomfort, dyspnea)
• Affiliation to the social security network
• Able to understand and sign a written informed consent form

You may not qualify if:

• Need for hospitalization according to updated French guidelines (ministère de la santé\_04/04/2020)
• Patient in long-term care facility
• Patient without concern confirmation of COVID-19 by laboratory (PCR swab) test or chest CT
• Known hypersensitivity or contra-indication to the 3 experimental treatments (azithromycin, hydroxychloroquine, lopinavir/ritonavir).
• Any reason making follow up of the patient impossible during the study period.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Related Publications (12)

• Guan WJ, Liang WH, Zhao Y, Liang HR, Chen ZS, Li YM, Liu XQ, Chen RC, Tang CL, Wang T, Ou CQ, Li L, Chen PY, Sang L, Wang W, Li JF, Li CC, Ou LM, Cheng B, Xiong S, Ni ZY, Xiang J, Hu Y, Liu L, Shan H, Lei CL, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Cheng LL, Ye F, Li SY, Zheng JP, Zhang NF, Zhong NS, He JX; China Medical Treatment Expert Group for COVID-19. Comorbidity and its impact on 1590 patients with COVID-19 in China: a nationwide analysis. Eur Respir J. 2020 May 14;55(5):2000547. doi: 10.1183/13993003.00547-2020. Print 2020 May.

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  PMID: 17629679 BACKGROUND

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

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MeSH Terms

Interventions

Azithromycin; Hydroxychloroquine; Lopinavir; Ritonavir

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Jean-Marc Naccache, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: May 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 19, 2021
• Last Updated: April 27, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share