An interventional study of Hydroxychloroquine Sulfate 200 MG [Plaquenil] in Coronavirus Infection, sponsored by Taoyuan General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by Taoyuan General Hospital · Not applicable, Interventional, and Treatment
The effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Taoyuan General Hospital is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients have mild (no pneumonia) to moderate disease (pneumonia without respiratory distress) according to the following World Health Organization (WHO) definition of COVID-19 clinical syndromes:
Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhoea, nausea and vomiting.
Adult with pneumonia but no signs of severe pneumonia and no need for supplemental oxygen.
Exclusion Criteria:
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]
The comparison group will receive standard of care, i.e., supportive treatment for subjects with mild COVID-19 clinical illness.
Hydroxychloroquine Sulfate is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
Also known as: Plaquenil
Time to negatively RT-PCR
To evaluate the efficacy of HCQ, with respect to the time to negatively RT-PCR assessments in COVID-19 patients.
Time frame: 14 days
Virologic assessment
To evaluate the efficacy of HCQ in the aspect of virologic assessments in COVID-19 patients
Time frame: 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety and tolerability of HCQ
Time frame: 28 days
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Plan to share: No — The study outcome will be shared with the experts and persons interested in this field.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Taoyuan General Hospital