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

Not yet recruiting
COVID-19

Drug: Lopinavir-Ritonavir Drug Combination
400mg/100mg taken orally twice daily for 14 days.
Standard Care plus lopinavir/ritonavir

Combination Product: Standard Care
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
Standard Care
Standard Care plus lopinavir/ritonavir

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years
Contacts

Rebecca F Grais
+3314021555
rebecca.grais@epicentre.msf.org

Rebecca F Grais
Study Director
Epicentre

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Eric Adehossi
Principal Investigator
Hôpital Général de Référence de Niamey

Epicentre
Université Abdou Moumouni
Centre de Recherche Médicale et Sanitaire
Ministry of Public Health, Republic of Niger
NCT Number
MeSH Terms
Ritonavir
Lopinavir