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Unable to find suitable site Principal Investigator. This study did not start and was withdrawn as of Aug 2020 (have updated as of Sept 2020, please proceed to update the status of study withdrawal accordingly)
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| Name | Class |
|---|---|
| Ministry of Health, Singapore | OTHER_GOV |
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COVID-19 virus remains in infected patients for extended periods of time. A great resource burden is placed on the healthcare system and society at large to isolate COVID-19 patients for prolonged periods. Thus, being able to increase the rate of viral clearance, thus reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to free up resources for those who require it. The investigators designed a randomized controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19 infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days of TCM treatment when compared to the group of patients provided with standard care and placebo. Patients will be recruited from community isolation facilities, and have onset of symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates the time taken for relief of clinical symptoms associated with COVID-19 and assesses the safety of the TCM treatment given to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lianhua Qingwen | Drug | The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who test negative for COVID-19 | after 8 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken in days for relief of clinical symptoms | during the 8-day course of treatment | |
| Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness | after 8 days of treatment and at the end of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Zhao | Nanyang Technological University | Principal Investigator |
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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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| Placebo | Drug | The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal |
|
| Proportion of participants who test positive for COVID-19 with Ct value>30 | after 8 days of treatment |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |