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Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.
Hydroxychloroquine (HCQ) is licensed for the chemoprophylaxis and treatment of malaria and as a disease modifying antirheumatic drug. It has a long history of being safe and well tolerated at typical doses. HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. This study is designed to evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care workers at high risk of occupational exposure to SARS-CoV-2 compared to the eligible cohort that declines treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCQ Group | Experimental | Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ |
|
| Control Group | No Intervention | approximately 50 HCW who choose not to be provided HCQ |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine (HCQ) | Drug | Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline. | Baseline to 1 month post-baseline |
| Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | To characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire). | 4 Weeks Prior to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population | Day 90 |
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Inclusion Criteria for Group A and B
Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria
Willing and able to provide informed consent
Exclusion Criteria for Group A only :
Known hypersensitivity to hydroxychloroquine or chloroquine
Known diagnosis of COVID-19
Concomitant use of
History of Torsades de pontes
History of retinal disease
Known chronic kidney disease ≥ stage 4
Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)
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| Name | Affiliation | Role |
|---|---|---|
| H. Michael Belmont, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Raabe VN, Fleming A, Samanovic MI, Lai L, Belli HM, et al. (2022) Hydroxychloroquine Pre-Exposure Prophylaxis to Prevent SARS-CoV-2 Among Health Care Workers at High Risk For SARS-CoV-2 Exposure: A Nonrandomized Controlled Trial. Infect Dis Diag Treat 6: 201. |
| Label | URL |
|---|---|
| DOI: https://doi.org/10.29011/2577-1515.100201. | View source |
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Study internal to NYU at this time
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| ID | Title | Description |
|---|---|---|
| FG000 | HCQ Group | Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days |
| FG001 | Control Group | approximately 50 HCW who choose not to be provided HCQ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HCQ Group | Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline. | Posted | Count of Participants | Participants | Baseline to 1 month post-baseline |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCQ Group | Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Michael Belmont, MD | NYU Langone Health - Bellevue Hospital | 646-501-7400 | Michael.Belmont@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 | Sep 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Total number of participant: 350 (Group A and B)
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Open Label
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| Did not complete all study visits |
|
approximately 50 HCW who choose not to be provided HCQ
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | To characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire). | Posted | Count of Participants | Participants | 4 Weeks Prior to Baseline |
|
|
|
| Secondary | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 8 |
| 83 |
| EG001 | Control Group | approximately 50 HCW who choose not to be provided HCQ | 0 | 47 | 0 | 47 | 0 | 47 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hair Loss | General disorders | Non-systematic Assessment |
|
| Appetite Loss | General disorders | Non-systematic Assessment |
|
| Gastrointestinal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |