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

Phase 3

Withdrawn

• Conditions: Covid-19
• Interventions: Combination Product: Standard Care; Drug: Lopinavir-Ritonavir Drug Combination

• Registration Number: NCT04409483
• Lead Sponsor: Epicentre

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study Start: 2020-06-01
• Study First Posted: 2020-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Standard care for COVID-19 according to the national guidelines of Niger
Standard Care plus lopinavir/ritonavir	Standard Care	Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
Standard Care plus lopinavir/ritonavir	Lopinavir-Ritonavir Drug Combination	Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir

Primary Outcome Measures

Name	Time	Method
Hospitalization or death	15 days following randomization	Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause

Secondary Outcome Measures

Name	Time	Method
Time to hospitalization	28 days following randomization	Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
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
Length of hospitalization	28 days following randomization	Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
Admission to intensive care	28 days following randomization	Proportion of participants admitted to an intensive care unit
All-cause mortality	28 days following randomization	Death due to any cause