Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
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 | Target |
|---|---|---|---|
| Hydroxychloroquine | Oral | Tablet |
-
|
|
Lopinavir/ritonavir Primary Drug
|
Oral | Tablet | HIV protease |
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
show details
shkimmd@amc.seoul.kr |
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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2024;.
Available from: URL: http://clinicaltrials.gov
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