NCT04307693

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

March 10, 2020

Last Update Submit

May 25, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Viral load change

    hospital day 3, 5, 7, 10, 14, 18

  • Time to clinical improvement (TTCI)

    up to 28 days

  • Percentage of progression to supplemental oxygen requirement 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

    hospital day 7

  • Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission

    up to 28 days

  • +3 more secondary outcomes

Study Arms (3)

Lopinavir/ritonavir

EXPERIMENTAL

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

Drug: Lopinavir/ritonavir

Hydroxychloroquine

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine sulfate

Control

NO INTERVENTION

No lopinavir/ritonavir and hydroxychloroquine

Interventions

Lopinavir/ritonavirDRUG

Lopinavir / Ritonavir tablet

Also known as: Kaletra
Lopinavir/ritonavir
Hydroxychloroquine sulfateDRUG

Hydroxychloroquine sulfate tablet

Also known as: Oxiklorin
Hydroxychloroquine

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed mild COVID-19 (NEWS scoring system 0-4)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32618282DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Lopinavirlopinavir-ritonavir drug combinationHydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, open labelled, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

March 11, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)