COVID-19PREVENTNCT04371926
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk
A study testing Hydroxychloroquine Sulfate in people with COVID-19, run by Texas Cardiac Arrhythmia Research Foundation.
Trial summary
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet. Read more about this study
- Who is it for?
- Ages 18 months to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jul 2021
- Phase
- Interventional
- 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 months to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female over 18 years of age at the time of enrollment
- COVID-19 test positive patients with mild-moderate symptoms including fever >37.50 F
- Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19
Who cannot join
- Hepatic cirrhosis or active hepatitis B or C
- Severe renal disease
- Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
- Contraindication to HCQ
- Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
- Pregnant or breast feeding
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- Known history of long QT syndrome (QTc >500 ms on electrocardiogram)
- Seizure disorder
- Body weight <50kg
- Psoriasis
- Unwilling to provide informed consent
About this study
Official title: Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
Read the detailed description
This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine Sulfate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulfateDrug
Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
Staff will receive HCQ sulfate 400mg/week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| HCQ arm | Active comparator | COVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks Receives: Drug: Hydroxychloroquine Sulfate |
| No-HCQ arm | No intervention | Will receive standard treatment as needed, but no HCQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach normal body temperature
Time to reach normal body temperature (TNBT), ≤37.50 C
Measured: 1 month
Development of COVID-19 symptoms during HCQ preventive therapy in staff
Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
Measured: 1 month
Secondary outcomes (2)
COVID-19 test result at follow-up in patients
Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group
Measured: 6 days
Worsening of symptoms in COVID-19 patients
Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Concerned about the adverse effects of HCQ
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group. Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, St. David's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371926
- Sponsor's protocol ID
- TCAI_PREVENT
- Acronym
- PREVENT
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
- ClinicalTrials.gov ID
- NCT04371926
- Acronym / sponsor ID
- PREVENT / TCAI_PREVENT
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Concerned about the adverse effects of HCQ
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 1 May 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.
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
Detailed description
This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Symptomatic patients will be randomized to hydroxychloroquine (HCQ) vs no-HCQ group. Similarly, hospital staff with high risk of exposure will be randomized to HCQ vs no-HCQ group
| Arm | Type | Receives |
|---|---|---|
| HCQ arm | Active comparator | Drug: Hydroxychloroquine SulfateCOVID-19 positive cases will receive receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff randomized to this group will receive HCQ sulfate 400 mg/week for 4 weeks |
| No-HCQ arm | No intervention | –Will receive standard treatment as needed, but no HCQ |
Who may qualify
- Ages
- 18 months to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over 18 years of age at the time of enrollment
- COVID-19 test positive patients with mild-moderate symptoms including fever >37.50 F
- Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19
Key exclusion criteria (11 listed)
- Hepatic cirrhosis or active hepatitis B or C
- Severe renal disease
- Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
- Contraindication to HCQ
- Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
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 SulfatePatients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course. Staff will receive HCQ sulfate 400mg/week for 4 weeks | Drug | HCQ arm |
Primary outcome
Time to reach normal body temperature
Time frame: 1 month
Time to reach normal body temperature (TNBT), ≤37.50 C
Development of COVID-19 symptoms during HCQ preventive therapy in staff
Time frame: 1 month
Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
2 secondary outcomes
COVID-19 test result at follow-up in patients
Time frame: 6 days
Worsening of symptoms in COVID-19 patients
Time frame: 1 month
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 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Natale, MD principal investigator
St. David's Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine Sulfate in people with COVID-19, run by Texas Cardiac Arrhythmia Research Foundation.
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 3 inclusion and 11 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 4 Jun 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.
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?
Time to reach normal body temperature (time frame: 1 month). The study lists 2 primary outcomes in all. 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 4 Jun 2020.