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

Epicentre

Status and phase: Withdrawn; Phase 3

Conditions: Covid-19

Treatments: Drug: Lopinavir-Ritonavir Drug Combination; Combination Product: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04409483

Trascov

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Combination Product: Standard Care

Standard Care plus lopinavir/ritonavir

Experimental group

Description:

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

Treatment:

Combination Product: Standard Care

Drug: Lopinavir-Ritonavir Drug Combination