Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

Asan Medical Center

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Hydroxychloroquine sulfate; Drug: Lopinavir/ritonavir

Study type: Interventional

Funder types: Other

Identifiers

NCT04307693

S2020-0472-0001

Details and patient eligibility

About

In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

Full description

This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.

Enrollment: 65 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed mild COVID-19 (NEWS scoring system 0-4)

Exclusion criteria

• unable to take oral medication
• pregnancy or breast feeding
• immunocompromised patients
• creatinine clearance (CCL) < 30 mL/min
• aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Lopinavir/ritonavir

Experimental group

Description:

Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days

Treatment:

Drug: Lopinavir/ritonavir

Hydroxychloroquine

Active Comparator group

Description:

Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days

Treatment:

Drug: Hydroxychloroquine sulfate

Control

No Intervention group

Description:

No lopinavir/ritonavir and hydroxychloroquine