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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Lopinavir/ritonavir; Drug: Hydroxychloroquine sulfate

• Registration Number: NCT04307693
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-03-10
• Study Start: 2020-03-11
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lopinavir/ritonavir	Lopinavir/ritonavir	Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days
Hydroxychloroquine	Hydroxychloroquine sulfate	Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days

Primary Outcome Measures

Name	Time	Method
Viral load	hospital day 3, 5, 7, 10, 14, 18	Area under the curve (AUC) of Ct value or viral copies number per mL

Secondary Outcome Measures

Name	Time	Method
adverse effects	up to 28 days	Safety and tolerability, as assessed by adverse effects
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission	up to 28 days	Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Concentration of Lopinavir/ritonavir and hydroxychloroquine	1, 2, 4, 5, 12 hours after taking intervention medicine	Concentration of Lopinavir/ritonavir and hydroxychloroquine
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7	hospital day 7	Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Viral load change	hospital day 3, 5, 7, 10, 14, 18	Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Percentage of progression to supplemental oxygen requirement by day 7	hospital day 7	Percentage of progression to supplemental oxygen requirement by day 7
Time to clinical improvement (TTCI)	up to 28 days	Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7	hospital day 7	Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of