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

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

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.

After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.

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