Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19
Condition: Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Hydroxychloroquine Sulfate 200 MG [Plaquenil]
Intervention type(s): Drug
Intervention description(s): Hydroxychloroquine Sulfate is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
Other intervention name(s): Plaquenil
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
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)
Primary purpose: Treatment
Keywords: COVID-19