Covid-19
Conditions
Brief 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.
Detailed description
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.
Interventions
400mg/100mg taken orally twice daily for 14 days.
COMBINATION_PRODUCTStandard Care
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
Sponsors
Université Abdou Moumouni
Centre de Recherche Médicale et Sanitaire
Ministry of Public Health, Republic of Niger
Epicentre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization or death | 15 days following randomization | Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to hospitalization | 28 days following randomization | Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%) |
| Length of hospitalization | 28 days following randomization | Total duration of hospitalization associated with desaturation (SpO2 ≤92%) |
| All-cause mortality | 15 days following randomization | Death due to any cause |
| Adverse events | 28 days following randomization | Proportion of participants having an adverse event |
| Serious adverse events | 28 days following randomization | Proportion of participants having a serious adverse event |
| Admission to intensive care | 28 days following randomization | Proportion of participants admitted to an intensive care unit |
Outcome results
None listed