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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

Standard care for COVID-19 according to the national guidelines of Niger

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type COMBINATION_PRODUCT

Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Standard Care plus lopinavir/ritonavir

Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir

Group Type EXPERIMENTAL

Lopinavir-Ritonavir Drug Combination

Intervention Type DRUG

400mg/100mg taken orally twice daily for 14 days.

Standard Care

Intervention Type COMBINATION_PRODUCT

Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Interventions

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Lopinavir-Ritonavir Drug Combination

400mg/100mg taken orally twice daily for 14 days.

Intervention Type DRUG

Standard Care

Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No