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The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .
This is a phase IV, open-labelled, randomized controlled clinical trial. A total of 125 cases who are novel coronavirus positive are planned to be recruited. These cases are randomized into 3 groups: in group A(Standard treatment+lopinavir/ritonavir), 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). In group B(Standard treatment+arbidol) , 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). In group C(Standard treatment), 25 cases are only given ordinary treatment. The observation duration is 21 days. Patients will be followed up at baseline (day 0) and day 2, 4, 7, 10,14, 21 after receiving indicated treatment. The primary observed indicators include viral nucleic in acid nose / throat swab, body temperature, respiratory rate, oxygen saturation of blood, chest imaging. The secondary observed indicators include but not limited to blood pressure, heart rate, blood routine test, liver and kidney function, myocardial enzyme, flow cytometry classification and counting, cytokines, other infection indicators, conditions and parameters of auxiliary respiration, the total days in hospital, exacerbation and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-Standard treatment+lopinavir/ritonavir | Experimental | In group A, 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). |
|
| Group B-Standard treatment+arbidol | Active Comparator | In group B, 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). |
|
| Group C-Standard treatment | No Intervention | In group C, 25 cases are only given ordinary treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir and Ritonavir Tablets | Drug | As indicated in arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of virus inhibition | Novel coronaviral nucleic acid is measured in nose / throat swab at each time point. | Day 0, 2, 4, 7, 10, 14 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| The disease prorogation-temperature | Body temperature will be followed everyday during time frame. | Day 0 till day 21 |
| The disease prorogation-respiratory function 1 | Respiratory rate will be followed everyday during time frame. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients health condition-routine test | Blood pressure and heart rate will be followed everyday during time frame. | Day 0 till day 21 |
| Patients health condition-liver function | Liver function will be assessed as AST, ALT and TBIL at each time point. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Eighth People's Hospital | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32838353 | Derived | Li Y, Xie Z, Lin W, Cai W, Wen C, Guan Y, Mo X, Wang J, Wang Y, Peng P, Chen X, Hong W, Xiao G, Liu J, Zhang L, Hu F, Li F, Zhang F, Deng X, Li L. Efficacy and Safety of Lopinavir/Ritonavir or Arbidol in Adult Patients with Mild/Moderate COVID-19: An Exploratory Randomized Controlled Trial. Med. 2020 Dec 18;1(1):105-113.e4. doi: 10.1016/j.medj.2020.04.001. Epub 2020 May 19. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C086979 | umifenovir |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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125 patients are randomized in 3 groups (2:2:1). In group A(Standard treatment+lopinavir/ritonavir) , 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). In group B (Standard treatment+arbidol), 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). In group C (Standard treatment), 25 cases are only given ordinary treatment.
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| Arbidol | Drug | As indicated in arm/group descriptions |
|
| Day 0 till day 21 |
| The disease prorogation-respiratory function 2 | Oxygen saturation of blood will be followed everyday during time frame. | Day 0 till day 21 |
| The disease prorogation-respiratory function 3 | Chest imaging will be taken at each time point. | Day 0, 4, 7, 10, 14 and 21 |
| Day 0, 4, 7, 10, 14 and 21 |
| Patients health condition-kidney function | Kidney function will be assessed as eGFR and creatine clearance rate at each time point. | Day 0, 4, 7, 10, 14 and 21 |
| Patients health condition-other blood routine test | Blood routine and myocardial enzyme will be measured at each time point. | Day 0, 4, 7, 10, 14 and 21 |
| Patients health condition-blood routine test | Flow cytometry classification and counting and cytokines will be measured at each time point. | Day 0, 4, 7, 10, 14 and 21 |
| D007239 |
| Infections |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |