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.
This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Lopinavir / Ritonavir tablet
Hydroxychloroquine sulfate tablet
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Viral load
Area under the curve (AUC) of Ct value or viral copies number per mL
Time frame: hospital day 3, 5, 7, 10, 14, 18
Viral load change
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)
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
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
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
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
Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Time frame: hospital day 7
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adverse effects
Safety and tolerability, as assessed by adverse effects
Time frame: up to 28 days
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Concentration of Lopinavir/ritonavir and hydroxychloroquine
Time frame: 1, 2, 4, 5, 12 hours after taking intervention medicine