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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid-19

Intervention / Treatment
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* Drug: Lopinavir-Ritonavir Drug Combination
* Combination Product: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Standard care for COVID-19 according to the national guidelines of Niger | Combination Product: Standard Care<br>* Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily<br>|
| Experimental: Standard Care plus lopinavir/ritonavir<br>Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir | Drug: Lopinavir-Ritonavir Drug Combination<br>* 400mg/100mg taken orally twice daily for 14 days.<br>Combination Product: Standard Care<br>* Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization or death | Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause | 15 days following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death due to any cause | 15 days following randomization | 
| All-cause mortality | Death due to any cause | 28 days following randomization | 
| Time to hospitalization | Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%) | 28 days following randomization | 
| Length of hospitalization | Total duration of hospitalization associated with desaturation (SpO2 ≤92%) | 28 days following randomization | 
| Admission to intensive care | Proportion of participants admitted to an intensive care unit | 28 days following randomization | 
| Adverse events | Proportion of participants having an adverse event | 28 days following randomization | 
| Serious adverse events | Proportion of participants having a serious adverse event | 28 days following randomization |