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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342156
Recruitment Status : Withdrawn (The number of patients with COVID-19 in Singapore was coming down for the community and the concerns about the potential side effects particularly when the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.)
First Posted : April 10, 2020
Last Update Posted : October 8, 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

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date October 8, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28. [ Time Frame: Until day 28 ]
COVID-19 infection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2020)
  • Positive serology at day 28. [ Time Frame: 28 days ]
    Serology
  • Symptoms of COVID-19. [ Time Frame: Until day 28 ]
    COVID-19
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19
Official Title  ICMJE Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus Infection
  • Hydroxychloroquine Adverse Reaction
Intervention  ICMJE Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
Oral tablet of Hydroxychloroquine sulfate
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
  • Standard Preventive Measures
    No intervention. Standard recommended preventive measures by the ministry of health.
    Intervention: Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
3000
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 informed consent form (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 the time of screening or breastfeeding.
  3. Known allergy or hypersensitivity to HCQ or other aminoquinoline 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04342156
Other Study ID Numbers  ICMJE 2020/00402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tan Tock Seng Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tan Tock Seng Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Rupesh Agrawal, MD Tan Tock Seng Hospital
PRS Account Tan Tock Seng Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP