Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04384380|
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infection||Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]||Phase 4|
On December 31, 2019, an outbreak of respiratory illness later proved to be caused by a novel coronavirus, officially named Coronavirus Disease 2019 (COVID-19), was notified first in Wuhan, a city of Hubei province, People's Republic of China (PRC). COVID-19 rapidly spreads in China and to other parts of the world. Currently more than 370,000 laboratory-confirmed cases have been reported worldwide, and the case count has been rising daily, and caused a global health emergency. As of March 29, 2020, there were 298 confirmed cases in Taiwan.
This is a multi-center, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of Hydroxychloroquine Sulfate (HCQ) in adult Patients with mild to moderate coronavirus disease (COVID-19) compared to standard of care treatment (SOC). The primary endpoint for the study is to evaluate the efficacy of HCQ, with respect to the time to negatively rRT-PCR assessments from the randomization date up to 14 days. The secondary endpoint is to evaluate the efficacy of HCQ in the aspect of virological assessments and the change of clinical symptoms. In addition, the safety and tolerability of HCQ will be evaluated during treatment period in COVID-19 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study will employ an open-label parallel design, to evaluate the efficacy and safety between hydroxychloroquine sulfate (plaquenil) and controlled standard of care treatment. The administration plan of HCQ is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7. All of the enrolled subjects will receive standard of care. The comparison group will receive standard of care, i.e., supportive treatment for subjects with mild COVID-19 clinical illness.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Randomized, Open-label, Controlled Trial to Evaluate the Efficacy and Tolerability of Hydroxychloroquine (HCQ) in Adult Patients With Mild to Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: HCQ in adult Patients with COVID-19
The administration plan of HCQ is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
Hydroxychloroquine Sulfate is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
Other Name: Plaquenil
No Intervention: standard of care treatment (SOC)
The comparison group will receive standard of care, i.e., supportive treatment for subjects with mild COVID-19 clinical illness.
- Time to negatively RT-PCR [ Time Frame: 14 days ]To evaluate the efficacy of HCQ, with respect to the time to negatively RT-PCR assessments in COVID-19 patients.
- Virologic assessment [ Time Frame: 14 days ]To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 28 days ]To evaluate the safety and tolerability of HCQ
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384380
|Contact: Shu-Hsing Cheng, Dr.||+886-3-3699721 ext email@example.com|
|Taoyuan General Hospital, Ministry of Health and Welfare||Recruiting|
|Taoyuan City, Taiwan, 320|
|Contact: YUNG-NIEN HSU, Dean +886-3-3699721 ext 4572 firstname.lastname@example.org|
|Principal Investigator: Shu-Hsing Cheng, Dr.|
|Sub-Investigator: Chien-Yu Cheng, Dr.|
|Sub-Investigator: Yi-Chun Lin, Dr.|
|Sub-Investigator: Jang-bin Chen, Dr.|
|Principal Investigator:||Shu-Hsing Cheng, Dr.||Taoyuan General Hospital, Ministry of Health and Welfare|