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

Primary Purpose

Coronavirus Infection, Hydroxychloroquine Adverse Reaction

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Hydroxychloroquine Sulfate 200 milligram (mg) Tab

About this trial

This is an interventional prevention trial for Coronavirus Infection focused on measuring Post Exposure Prophylaxis (PEP), Hydroxychloroquine, Singapore, COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Aged 18 to 80 years.
History of close contact or exposure to positive COVID-19 cases in the same household.
Absence of symptoms resembling COVID-19 (e.g., fever and acute respiratory or gastrointestinal symptoms) for two weeks prior to enrolment for the study.
Able to give informed consent or in case of <21 and>/=18 years old subject, parents able to give consent for those individuals. In the event the household is unable to read or sign/date the ICF, an impartial witness to be present to ascertain the information, comprehension and voluntariness. The impartial witness must be able to read the informed consent form (ICF).
Able to comply with study procedures and follow-up
Singapore citizen, permanent resident or long-term pass-holder.

Exclusion Criteria:

Person diagnosed with COVID-19 infection.
Pregnant at the time of screening or breastfeeding.
Known allergy or hypersensitivity to HCQ or other aminoquinoline compounds.
Already on HCQ for different indications (e.g., rheumatological diseases, malaria prophylaxis)
Diagnosis of other systemic viral or bacterial infection.
Use of systemic immunosuppressant agents within 90 days of enrollment (e.g., corticosteroids and immunomodulatory therapy)
History of immunocompromised state.
History of psychiatric illness.
History of psoriasis or porphyria.
History of cardiac disease.
Other major comorbidities that contraindicate the use of HCQ: i. Hematologic malignancy, ii. Stage 4-5 chronic kidney disease or end-stage renal failure, iii. history of ventricular arrhythmias, iv. current use of drugs that prolong the QT interval
History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Bradycardia <50beats/min.
Uncorrected hypokalemia
Uncorrected hypomagnesemia.
Unwillingness to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while on study and for at least 30 days after last dose.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Standard Preventive Measures

Arm Description

Treatment arm will be given Hydroxychloroquine sulfate. Dose: 800 milligrams (mg) (4 pills of 200mg) in two divided doses on day 1 followed by 400mg (2 pills of 200mg) in two divided doses on day 2, 3,4, 5. Mode of administration: Oral pills of 200mg of HCQ; Supply: The total supply of all the pills (12 pills of 200mg per subject in the study group) will be given to the recruited subject from day 1.

No intervention. Standard recommended preventive measures by the ministry of health.

Outcomes

Primary Outcome Measures

positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.

COVID-19 infection

Secondary Outcome Measures

Positive serology at day 28.

Serology

Symptoms of COVID-19.

COVID-19

Full Information

NCT ID

NCT04342156

First Posted

April 8, 2020

Last Updated

October 5, 2020

Sponsor

Tan Tock Seng Hospital

Collaborators

National Center for Infectious Diseases, Singapore Clinical Research Institute, Singapore Eye Research Institute, Saw Swee Hock School of Public Health, Duke-NUS Graduate Medical School, Netherlands: Ministry of Health, Welfare and Sports

1. Study Identification

Unique Protocol Identification Number

NCT04342156

Brief Title

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

Acronym

SHARP COVID-19

Official Title

Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The number of patients with COVID-19 in Singapore was coming down for the community and the concerns about the potential side effects particularly when the baseline ECG and serum electrolytes was not proposed.

Study Start Date

April 2020 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tan Tock Seng Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection, Hydroxychloroquine Adverse Reaction

Keywords

Post Exposure Prophylaxis (PEP), Hydroxychloroquine, Singapore, COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Standard Preventive Measures

Arm Type

Other

Arm Description

No intervention. Standard recommended preventive measures by the ministry of health.

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine Sulfate 200 milligram (mg) Tab

Intervention Description

Oral tablet of Hydroxychloroquine sulfate

Primary Outcome Measure Information:

Title

positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.

Description

COVID-19 infection

Time Frame

Until day 28

Secondary Outcome Measure Information:

Title

Positive serology at day 28.

Description

Serology

Time Frame

28 days

Title

Symptoms of COVID-19.

Description

COVID-19

Time Frame

Until day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Aged 18 to 80 years. History of close contact or exposure to positive COVID-19 cases in the same household. Absence of symptoms resembling COVID-19 (e.g., fever and acute respiratory or gastrointestinal symptoms) for two weeks prior to enrolment for the study. Able to give informed consent or in case of <21 and>/=18 years old subject, parents able to give consent for those individuals. In the event the household is unable to read or sign/date the ICF, an impartial witness to be present to ascertain the information, comprehension and voluntariness. The impartial witness must be able to read the informed consent form (ICF). Able to comply with study procedures and follow-up Singapore citizen, permanent resident or long-term pass-holder. Exclusion Criteria: Person diagnosed with COVID-19 infection. Pregnant at the time of screening or breastfeeding. Known allergy or hypersensitivity to HCQ or other aminoquinoline compounds. Already on HCQ for different indications (e.g., rheumatological diseases, malaria prophylaxis) Diagnosis of other systemic viral or bacterial infection. Use of systemic immunosuppressant agents within 90 days of enrollment (e.g., corticosteroids and immunomodulatory therapy) History of immunocompromised state. History of psychiatric illness. History of psoriasis or porphyria. History of cardiac disease. Other major comorbidities that contraindicate the use of HCQ: i. Hematologic malignancy, ii. Stage 4-5 chronic kidney disease or end-stage renal failure, iii. history of ventricular arrhythmias, iv. current use of drugs that prolong the QT interval History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Bradycardia <50beats/min. Uncorrected hypokalemia Uncorrected hypomagnesemia. Unwillingness to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while on study and for at least 30 days after last dose.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rupesh Agrawal, MD

Organizational Affiliation

Tan Tock Seng Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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

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