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

NCT ID: NCT04307693

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2020-04-30

Brief Summary

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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

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

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, open labelled, randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lopinavir/ritonavir

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

Group Type EXPERIMENTAL

Lopinavir/ritonavir

Intervention Type DRUG

Lopinavir / Ritonavir tablet

Hydroxychloroquine

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

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine sulfate

Intervention Type DRUG

Hydroxychloroquine sulfate tablet

Control

No lopinavir/ritonavir and hydroxychloroquine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lopinavir/ritonavir

Lopinavir / Ritonavir tablet

Intervention Type DRUG

Hydroxychloroquine sulfate

Hydroxychloroquine sulfate tablet

Intervention Type DRUG

Other Intervention Names

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Kaletra Oxiklorin

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sung-Han Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32618282 (View on PubMed)

Other Identifiers

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S2020-0472-0001

Identifier Type: -

Identifier Source: org_study_id

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