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

COVID-19 Clinical Trial

Official title:

Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04307693
• Other study ID #: S2020-0472-0001
• Status: Terminated
• Phase: Phase 2
• Start date: March 11, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Drug:
• Lopinavir/ritonavir
Lopinavir / Ritonavir tablet
• Hydroxychloroquine sulfate
Hydroxychloroquine sulfate tablet

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load	Area under the curve (AUC) of Ct value or viral copies number per mL	hospital day 3, 5, 7, 10, 14, 18
Secondary	Viral load change	Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)	hospital day 3, 5, 7, 10, 14, 18
Secondary	Time to clinical improvement (TTCI)	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	up to 28 days
Secondary	Percentage of progression to supplemental oxygen requirement by day 7	Percentage of progression to supplemental oxygen requirement by day 7	hospital day 7
Secondary	Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7	Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7	hospital day 7
Secondary	Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission	Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission	up to 28 days
Secondary	Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7	Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7	hospital day 7
Secondary	adverse effects	Safety and tolerability, as assessed by adverse effects	up to 28 days
Secondary	Concentration of Lopinavir/ritonavir and hydroxychloroquine	Concentration of Lopinavir/ritonavir and hydroxychloroquine	1, 2, 4, 5, 12 hours after taking intervention medicine