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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04307693
Recruitment Status : Terminated (Terminated early because no patients were further enrolled since mid-Apr 2020.)
First Posted : March 13, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine sulfate Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, open labelled, randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Actual Study Start Date : March 11, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lopinavir/ritonavir
Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days
 Drug: Lopinavir/ritonavir
Lopinavir / Ritonavir tablet
Other Name: Kaletra
Active Comparator: Hydroxychloroquine
Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days
 Drug: Hydroxychloroquine sulfate
Hydroxychloroquine sulfate tablet
Other Name: Oxiklorin
No Intervention: Control
No lopinavir/ritonavir and hydroxychloroquine


Outcome Measures
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Primary Outcome Measures :
  1. Viral load [ Time Frame: 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 :
  1. Viral load change [ Time Frame: 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)

  2. Time to clinical improvement (TTCI) [ Time Frame: 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

  3. Percentage of progression to supplemental oxygen requirement by day 7 [ Time Frame: hospital day 7 ]
    Percentage of progression to supplemental oxygen requirement by day 7

  4. Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 [ Time Frame: hospital day 7 ]
    Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7

  5. Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission [ Time Frame: up to 28 days ]
    Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

  6. Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 [ Time Frame: hospital day 7 ]
    Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7

  7. adverse effects [ Time Frame: up to 28 days ]
    Safety and tolerability, as assessed by adverse effects

  8. Concentration of Lopinavir/ritonavir and hydroxychloroquine [ Time Frame: 1, 2, 4, 5, 12 hours after taking intervention medicine ]
    Concentration of Lopinavir/ritonavir and hydroxychloroquine


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307693


Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sung-Han Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04307693    
Other Study ID Numbers: S2020-0472-0001
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
Lopinavir
Hydroxychloroquine
 HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents