Status:
WITHDRAWN
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Lead Sponsor:
Epicentre
Collaborating Sponsors:
Université Abdou Moumouni
Centre de Recherche Médicale et Sanitaire
Conditions:
Covid-19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04409483
Start Date
June 1 2020
End Date
December 31 2020
Last Update
February 10 2021
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