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Terminated early because no patients were further enrolled since mid-Apr 2020.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lopinavir/ritonavir | Experimental | Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days |
|
| Hydroxychloroquine | Active Comparator | Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days |
|
| Control | No Intervention | No lopinavir/ritonavir and hydroxychloroquine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir | Drug | Lopinavir / Ritonavir tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Area under the curve (AUC) of Ct value or viral copies number per mL | hospital day 3, 5, 7, 10, 14, 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load change | Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18) | hospital day 3, 5, 7, 10, 14, 18 |
| Time to clinical improvement (TTCI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32618282 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Multicenter, open labelled, randomized clinical trial
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| Hydroxychloroquine sulfate | Drug | Hydroxychloroquine sulfate tablet |
|
|
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
| up to 28 days |
| Percentage of progression to supplemental oxygen requirement by day 7 | 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 | 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 | Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission | 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 | hospital day 7 |
| adverse effects | Safety and tolerability, as assessed by adverse effects | up to 28 days |
| Concentration of Lopinavir/ritonavir and hydroxychloroquine | Concentration of Lopinavir/ritonavir and hydroxychloroquine | 1, 2, 4, 5, 12 hours after taking intervention medicine |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002738 |
| Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |