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The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine and conventional treatments | Experimental | After randomization, subjects take hydroxychloroquine 400mg per day for 5 days, also take conventional treatments. |
|
| Conventional treatments | No Intervention | After randomization, subjects take conventional treatments without hydroxychloroquine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 | 3 days after randomization | |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 | 5 days after randomization | |
| The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 | 7 days after randomization | |
| The mortality rate of subjects at weeks 2 | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 14 days after randomization | |
| The critical illness rate of subjects at weeks 2 | The diagnosis of critical illness case was based on the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4) made by National Health Commission of the People's Republic of China. |
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Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China | ||
| Shanghai Public Health Clinical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32391667 | Derived | Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, Ling Y, Huang D, Song S, Zhang D, Qian Z, Li T, Shen Y, Lu H. [A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03. Chinese. |
| Label | URL |
|---|---|
| The results have been published on the Journal of Zhejiang University (Medical Sciences) | View source |
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| 14 days after randomization |
| Shanghai |
| Shanghai Municipality |
| China |
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D011024 | Pneumonia, Viral |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |