Coronavirus InfectionPhase 3SHARP COVID-19NCT04342156
Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19
A Phase 3 study testing Hydroxychloroquine Sulfate 200 milligram (mg) Tab in people with Coronavirus Infection and Hydroxychloroquine Adverse Reaction, run by Tan Tock Seng Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Hydroxychloroquine Adverse Reaction
- What is being tested?
- Hydroxychloroquine Sulfate 200 milligram (mg) Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
About this study
Official title: Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
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.
- Being tested
- Hydroxychloroquine Sulfate 200 milligram (mg) Tab
- Keywords
- Post Exposure Prophylaxis (PEP), Hydroxychloroquine, Singapore, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate 200 milligram (mg) TabDrug
Oral tablet of Hydroxychloroquine sulfate
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab |
| Standard Preventive Measures | Other | No intervention. Standard recommended preventive measures by the ministry of health. Receives: Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.
COVID-19 infection
Measured: Until day 28
Secondary outcomes (2)
Positive serology at day 28.
Serology
Measured: 28 days
Symptoms of COVID-19.
COVID-19
Measured: Until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Rupesh Agrawal, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342156
- Sponsor's protocol ID
- 2020/00402
- Acronym
- SHARP COVID-19
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
- ClinicalTrials.gov ID
- NCT04342156
- Acronym / sponsor ID
- SHARP COVID-19 / 2020/00402
- Keywords
- Post Exposure Prophylaxis (PEP), Hydroxychloroquine, Singapore, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- 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
- Study start
- Apr 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Hydroxychloroquine Sulfate 200 milligram (mg) TabTreatment 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. |
| Standard Preventive Measures | Other | Drug: Hydroxychloroquine Sulfate 200 milligram (mg) TabNo intervention. Standard recommended preventive measures by the ministry of health. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Sulfate 200 milligram (mg) TabOral tablet of Hydroxychloroquine sulfate | Drug | Intervention, Standard Preventive Measures |
Primary outcome
positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.
Time frame: Until day 28
COVID-19 infection
2 secondary outcomes
Positive serology at day 28.
Time frame: 28 days
Symptoms of COVID-19.
Time frame: Until day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupesh Agrawal, MD principal investigator
Tan Tock Seng Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine Sulfate 200 milligram (mg) Tab in people with Coronavirus Infection and Hydroxychloroquine Adverse Reaction, run by Tan Tock Seng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28. (time frame: Until day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.