Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19

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.

Conditions

• Coronavirus Infection
• Hydroxychloroquine Adverse Reaction

Interventions

DRUG

Hydroxychloroquine Sulfate 200 milligram (mg) Tab

Oral tablet of Hydroxychloroquine sulfate

Sponsors & Collaborators

• National Center for Infectious Diseases

  collaborator OTHER_GOV

• Singapore Clinical Research Institute

  collaborator OTHER

• Singapore Eye Research Institute

  collaborator OTHER

• Saw Swee Hock School of Public Health

  collaborator UNKNOWN

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Netherlands: Ministry of Health, Welfare and Sports

  collaborator OTHER_GOV

• Tan Tock Seng Hospital

  lead OTHER

Principal Investigators

• Rupesh Agrawal, MD · Tan Tock Seng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-30

Primary Completion

2020-08-31

Completion

2020-10-31