Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger

• Status: Withdrawn
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.

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

Details

• Lead Sponsor: Epicentre
• Collaborators: Centre de Recherche Médicale et Sanitaire; Ministry of Public Health, Republic of Niger; Université Abdou Moumouni
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Suspect, probable or confirmed case of COVID-19

• Men and women aged ≥12 years, including pregnant and breastfeeding women

• SpO2 ≥93% on room air

• Signature of informed consent form

Exclusion Criteria:

• Medical indication for hospitalization at the time of enrolment

• Severe chronic liver disease

• Known infection with HIV

• Known allergy or severe intolerance to lopinavir/ritonavir

• Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)

• Treatment with an antiviral medication in the 28 days prior to enrolment

• Dementia or other condition that interferes with active participation in data collection and obtaining informed consent