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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342156
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 20, 2020
Sponsor:
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
Information provided by (Responsible Party):
Tan Tock Seng Hospital

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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Hydroxychloroquine Adverse Reaction Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Intervention

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.

Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
Oral tablet of Hydroxychloroquine sulfate

Standard Preventive Measures
No intervention. Standard recommended preventive measures by the ministry of health.
Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
Oral tablet of Hydroxychloroquine sulfate




Primary Outcome Measures :
  1. positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28. [ Time Frame: Until day 28 ]
    COVID-19 infection


Secondary Outcome Measures :
  1. Positive serology at day 28. [ Time Frame: 28 days ]
    Serology

  2. Symptoms of COVID-19. [ Time Frame: Until day 28 ]
    COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Aged 18 to 80 years.
  2. History of close contact or exposure to positive COVID-19 cases in the same household.
  3. Absence of symptoms resembling COVID-19 (e.g., fever and acute respiratory or gastrointestinal symptoms) for two weeks prior to enrolment for the study.
  4. 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 ICF.
  5. Able to comply with study procedures and follow-up
  6. Singapore citizen, permanent resident or long-term pass-holder.

Exclusion Criteria:

  1. Person diagnosed with COVID-19 infection.
  2. Pregnant at time of screening or breastfeeding.
  3. Known allergy or hypersensitivity to HCQ or other aminoquinolline compounds.
  4. Already on HCQ for different indications (e.g., rheumatological diseases, malaria prophylaxis)
  5. Diagnosis of other systemic viral or bacterial infection.
  6. Use of systemic immunosuppressant agents within 90 days of enrollment (e.g., corticosteroids and immunomodulatory therapy)
  7. History of immunocompromised state.
  8. History of psychiatric illness.
  9. History of psoriasis or porphyria.
  10. History of cardiac disease.
  11. 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
  12. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
  13. Bradycardia <50beats/min.
  14. Uncorrected hypokalemia
  15. Uncorrected hypomagnesemia.
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342156


Contacts
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Contact: Rupesh Agrawal, MD 6357100 ext 7726 rupesh_agrawal@ttsh.com.sg

Sponsors and Collaborators
Tan Tock Seng Hospital
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
Investigators
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Principal Investigator: Rupesh Agrawal, MD Tan Tock Seng Hospital
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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04342156    
Other Study ID Numbers: 2020/00402
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tan Tock Seng Hospital:
Post Exposure Prophylaxis (PEP)
Hydroxychloroquine
Singapore
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents