Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lopinavir/ritonavir
Hydroxychloroquine sulfate
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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)
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Lopinavir/ritonavir
Hydroxychloroquine
Control
Arm Description
Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days
Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days
No lopinavir/ritonavir and hydroxychloroquine
Outcomes
Primary Outcome Measures
Viral load
Area under the curve (AUC) of Ct value or viral copies number per mL
Secondary Outcome Measures
Viral load change
Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
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
Percentage of progression to supplemental oxygen requirement by day 7
Percentage of progression to supplemental oxygen requirement by day 7
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
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
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
adverse effects
Safety and tolerability, as assessed by adverse effects
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04307693
Brief Title
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Official Title
Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated early because no patients were further enrolled since mid-Apr 2020.
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, open labelled, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lopinavir/ritonavir
Arm Type
Experimental
Arm Description
Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days
Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
No lopinavir/ritonavir and hydroxychloroquine
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir
Other Intervention Name(s)
Kaletra
Intervention Description
Lopinavir / Ritonavir tablet
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine sulfate
Other Intervention Name(s)
Oxiklorin
Intervention Description
Hydroxychloroquine sulfate tablet
Primary Outcome Measure Information:
Title
Viral load
Description
Area under the curve (AUC) of Ct value or viral copies number per mL
Time Frame
hospital day 3, 5, 7, 10, 14, 18
Secondary Outcome Measure Information:
Title
Viral load change
Description
Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Time Frame
hospital day 3, 5, 7, 10, 14, 18
Title
Time to clinical improvement (TTCI)
Description
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
Time Frame
up to 28 days
Title
Percentage of progression to supplemental oxygen requirement by day 7
Description
Percentage of progression to supplemental oxygen requirement by day 7
Time Frame
hospital day 7
Title
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Description
Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Time Frame
hospital day 7
Title
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Description
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Time Frame
up to 28 days
Title
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Description
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Time Frame
hospital day 7
Title
adverse effects
Description
Safety and tolerability, as assessed by adverse effects
Time Frame
up to 28 days
Title
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Description
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Time Frame
1, 2, 4, 5, 12 hours after taking intervention medicine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32618282
Citation
Lipsitch M, Perlman S, Waldor MK. Testing COVID-19 therapies to prevent progression of mild disease. Lancet Infect Dis. 2020 Dec;20(12):1367. doi: 10.1016/S1473-3099(20)30372-8. Epub 2020 May 6. No abstract available.
Results Reference
derived
Learn more about this trial
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
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