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

Trial Profile

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

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 28 May 2020

At a glance

  • Drugs Lopinavir/ritonavir (Primary) ; Hydroxychloroquine
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 20 May 2020 Status changed from recruiting to discontinued.
    • 16 Mar 2020 New trial record

Trial Overview

Purpose

The purpose of this study is to investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

Comments

According to ClinicalTrials.gov record, this study is terminated early because no patients were further enrolled since mid-Apr 2020.

Primary Endpoints

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

Other Endpoints

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

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

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

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

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

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

adverse effects

description: Safety and tolerability, as assessed by adverse effects
time_frame: up to 28 days

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 150

    Actual: 65

  • Sex male & female
  • Age Group 16-99 years; adolescent; adult; elderly

Patient Inclusion Criteria

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

Patient 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)

Trial Details

Identifiers

Identifier Owner
NCT04307693 ClinicalTrials.gov: US National Institutes of Health
S2020-0472-0001 -

Trial Dates

  • Initiation Dates

    Actual : 11 Mar 2020

  • Primary Completion Dates

    Planned : 01 May 2020

    Actual : 30 Apr 2020

  • End Dates

    Planned : 01 May 2020

    Actual : 30 Apr 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location South Korea
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Hydroxychloroquine Oral Tablet
Lopinavir/ritonavirPrimary Drug Oral Tablet

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

Hydroxychloroquine

Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days Drug: Hydroxychloroquine sulfate (Hydroxychloroquine sulfate tablet) Other Name: Oxiklorin

Control

No lopinavir/ritonavir and hydroxychloroquine

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Sung-Han Kim, MD.PhD
82-2-3010-3114 3305
shkimmd@amc.seoul.kr
show details
Asan Medical Center, University of Ulsan College of Medicine South-Korea

Centres

Centre Name Location Trial Centre Country
Asan Medical Center
-
-
Asan Medical Center, University of Ulsan College of Medicine Seoul South-Korea

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 28 May 2020
20 May 2020 Status change - discontinued Status changed from recruiting to discontinued. Updated 26 May 2020
16 Mar 2020 New trial record New trial record Updated 16 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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