Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19
Status:
Withdrawn
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global
economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed
cases, there is still no effective way to contain the disease. The transmission of COVID-19
occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and
indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of
confirmed cases is about 4%. These at-risk individuals are identified through contact tracing
and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has
yet to be a single effective, safe, and affordable pharmacological agent with such
capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent
which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the
invasion and intracellular replication of the virus. Existing studies have reported efficacy
of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of
patients suffering from significant side effects. However, existing studies are largely
limited by their small sample sizes. Furthermore, there has yet to be a published trial on
HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of
oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of
confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP
(treatment group) and no treatment (control group). Subjects will be followed up over a
course of 28 days, with daily symptom monitoring conducted over phone calls. Positive
outcomes from this study will provide a means for us to battle the COVID-19 pandemic.
Phase:
Phase 3
Details
Lead Sponsor:
Tan Tock Seng Hospital
Collaborators:
Duke-NUS Graduate Medical School National Center for Infectious Diseases Netherlands: Ministry of Health, Welfare and Sports Saw Swee Hock School of Public Health Singapore Clinical Research Institute Singapore Eye Research Institute