COVID-19
Conditions
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.
Detailed description
This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.
Interventions
DRUGLopinavir/ritonavir
Lopinavir / Ritonavir tablet
DRUGHydroxychloroquine sulfate
Hydroxychloroquine sulfate tablet
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, open labelled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral load | hospital day 3, 5, 7, 10, 14, 18 | Area under the curve (AUC) of Ct value or viral copies number per mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement (TTCI) | up to 28 days | 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 |
| Percentage of progression to supplemental oxygen requirement by day 7 | hospital day 7 | Percentage of progression to supplemental oxygen requirement by 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 NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 |
| Viral load change | hospital day 3, 5, 7, 10, 14, 18 | Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18) |
| Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 | hospital day 7 | Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 |
| adverse effects | up to 28 days | Safety and tolerability, as assessed by adverse effects |
| Concentration of Lopinavir/ritonavir and hydroxychloroquine | 1, 2, 4, 5, 12 hours after taking intervention medicine | Concentration of Lopinavir/ritonavir and hydroxychloroquine |
| Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission | up to 28 days | Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission |
Countries
South Korea
Outcome results
None listed