ProphylaxisPhase 3HERONCT04352946
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial
A Phase 3 study testing Hydroxychloroquine Pre-Exposure Prophylaxis in people with Prophylaxis and COVID-19, run by GeoSentinel Foundation at 1 site in United States.
Trial summary
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis, COVID-19, Health Care Worker
- What is being tested?
- Hydroxychloroquine Pre-Exposure Prophylaxis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 24 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care worker (HCW) at the hospital who work on a "full time" basis during the study period. For the purposes of the study, "health care workers" are physicians, nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters).
- Age ≥18 years.
- Ability to communicate with study staff in English
Who cannot join
- Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
- Current use of hydroxychloroquine for the treatment of a medical condition.
- Known prolonged QT syndrome, or concomitant medications which simultaneously may prolong the QTC that cannot be temporarily suspended/replaced. These are including but not limited to Class IA, IC and III antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists.
- Known pre-existing retinopathy of the eye.
- Disclosure of self-administered use of hydroxychloroquine or chloroquine currently under investigation <4 weeks prior to study. This window is intended to account for the drug half-life of HCQ (21 days).
- Baseline symptom of COVID-19 disease at enrollment and baseline viral detection specimen positive for SARS-COV-2. All participants with COVID-19 symptoms at enrollment will be directed to have confirmatory testing (within the department or occupational health as per the site guidelines). Participants who are negative for SARS-COV-2 will be redirected to enrollment procedures, those testing positive will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Center for Travel and Tropical Medicine
New York, New York, 10022
Bradley A Connor, MD, 212-988-2800, bconnor1@gmail.com
Marina Rogova, RN, 8434247542, marina.rogova@connormd.com
About this study
Official title: Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
Read the detailed description
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic.
Secondary outcomes include 1) Adverse events; 2) Duration of symptomatic COVID-19 disease; 3) Days hospitalized attributed to COVID-19; 4) Respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; 5) Mortality attributed to COVID-19 disease, and; 6) Number of days unable to work attributed to COVID-19. Laboratory markers within participants with confirmed COVID-19 will also be explored.
A total of 374 HCW will be randomized using a fixed 1:1 allocation ratio with randomization in permuted block of varying sizes from four to eight will be used to ensure equal allocation to each group. The study population will be health care workers at the New York Presbyterian Hospital - Cornell Campus and they will participate in the study for 90 days.
To determine if the intervention has been successful, the cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI). Investigators will also calculate adjusted risk ratios and risk differences including job class as a covariate and any other baseline clinical and demographic characteristics that are not balanced between the treatment and placebo arms using a log-binomial regression model.
- Conditions
- Prophylaxis, COVID-19, Health Care Worker, Hydroxychloroquine
- Being tested
- Hydroxychloroquine Pre-Exposure Prophylaxis, Placebo oral tablet
- 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 Pre-Exposure ProphylaxisDrug
Also called Hydroxychloroquine PreP, HCQ PreP
HCQ PreP 400mg daily
Placebo oral tabletDrug
Also called Placebo
Placebo tablets 400mg daily
| Study group | Role | What they receive |
|---|---|---|
| Hydrocholoroquine Pre-exposure prophylaxis | Experimental | HCQ will be administered as 400mg orally once for 60 days. Receives: Drug: Hydroxychloroquine Pre-Exposure Prophylaxis |
| Placebo | Placebo comparator | Placebo will be administered as 400mg orally once for 60 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of COVID-19 Infection
Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
Measured: 90 days
Secondary outcomes (6)
Adverse events incidence
Incidence of reported and grade of adverse events
Measured: 90 days
Duration of symptomatic COVID-19 disease
Duration in days of symptomatic COVID-19 disease in HCW who had disease
Measured: 90 days
Days hospitalized attributed to COVID-19
Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease
Measured: 90 days
Number or respiratory failure attributable to COVID-19 disease
Number of HCW with respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation in HCW who developed disease
Measured: 90 days
Mortality Incidence
Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease
Measured: 90 days
Days of work lost
Number of days unable to work attributed to COVID-19 in HCW who developed disease
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start24 Apr 2020 (estimated)
- Primary completion24 Jun 2020 (estimated)
- Study completion24 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProphylaxisStudies 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
- Model description
- HCW are randomized to either the study drug (HCQ) or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeoSentinel Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley A. Connor, M.D., GeoSentinel Foundation
- Investigators
- Bradley A Connor, MD, Principal investigator, Dr. Bradley A. Connor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352946
- Sponsor's protocol ID
- GFICOVID-19-1
- Acronym
- HERO
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: supporting made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04352946
- Acronym / sponsor ID
- HERO / GFICOVID-19-1
- Conditions
- Prophylaxis, COVID-19, Health Care Worker, Hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- GeoSentinel FoundationUniversity, hospital or other
- Study start
- 24 Apr 2020 (estimated)
- Primary completion
- 24 Jun 2020 (estimated)
- Study completion
- 24 Aug 2020 (estimated)
- First posted
- 20 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.
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
Detailed description
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic.
Secondary outcomes include 1) Adverse events; 2) Duration of symptomatic COVID-19 disease; 3) Days hospitalized attributed to COVID-19; 4) Respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; 5) Mortality attributed to COVID-19 disease, and; 6) Number of days unable to work attributed to COVID-19. Laboratory markers within participants with confirmed COVID-19 will also be explored.
A total of 374 HCW will be randomized using a fixed 1:1 allocation ratio with randomization in permuted block of varying sizes from four to eight will be used to ensure equal allocation to each group. The study population will be health care workers at the New York Presbyterian Hospital - Cornell Campus and they will participate in the study for 90 days.
To determine if the intervention has been successful, the cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI). Investigators will also calculate adjusted risk ratios and risk differences including job class as a covariate and any other baseline clinical and demographic characteristics that are not balanced between the treatment and placebo arms using a log-binomial regression model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HCW are randomized to either the study drug (HCQ) or placebo.
| Arm | Type | Receives |
|---|---|---|
| Hydrocholoroquine Pre-exposure prophylaxis | Experimental | Drug: Hydroxychloroquine Pre-Exposure ProphylaxisHCQ will be administered as 400mg orally once for 60 days. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo will be administered as 400mg orally once for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Health care worker (HCW) at the hospital who work on a "full time" basis during the study period. For the purposes of the study, "health care workers" are physicians, nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters).
- Age ≥18 years.
- Ability to communicate with study staff in English
Key exclusion criteria (6 listed)
- Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
- Current use of hydroxychloroquine for the treatment of a medical condition.
- Known prolonged QT syndrome, or concomitant medications which simultaneously may prolong the QTC that cannot be temporarily suspended/replaced. These are including but not limited to Class IA, IC and III antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists.
- Known pre-existing retinopathy of the eye.
- Disclosure of self-administered use of hydroxychloroquine or chloroquine currently under investigation <4 weeks prior to study. This window is intended to account for the drug half-life of HCQ (21 days).
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 Pre-Exposure ProphylaxisAlso: Hydroxychloroquine PreP, HCQ PrePHCQ PreP 400mg daily | Drug | Hydrocholoroquine Pre-exposure prophylaxis |
| Placebo oral tabletAlso: PlaceboPlacebo tablets 400mg daily | Drug | Placebo |
Primary outcome
Cumulative Incidence of COVID-19 Infection
Time frame: 90 days
Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
6 secondary outcomes
Adverse events incidence
Time frame: 90 days
Duration of symptomatic COVID-19 disease
Time frame: 90 days
Days hospitalized attributed to COVID-19
Time frame: 90 days
Number or respiratory failure attributable to COVID-19 disease
Time frame: 90 days
Mortality Incidence
Time frame: 90 days
Days of work lost
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: Yes. supporting made available to other researchers
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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.
Bradley A Connor, MD principal investigator
Dr. Bradley A. Connor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine Pre-Exposure Prophylaxis in people with Prophylaxis and COVID-19, run by GeoSentinel Foundation at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bradley A Connor, MD (9172138998, bconnor1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of COVID-19 Infection (time frame: 90 days). 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 22 Apr 2020.