COVID-19
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Total number of participant: 350 (Group A and B) * Group A: projected 300 (HCW choose to be provided HCQ) * Group B: projected 50 (HCW choose not to be provided HCQ)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Group A and B * Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria 1. Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE 2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period 3. Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period * 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 1. amiodarone 2. digoxin 3. flecainide 4. procainamide 5. propafenone * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | Baseline to 1 month post-baseline | Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline. |
| Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | 4 Weeks Prior to Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | Day 90 | To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| Control Group approximately 50 HCW who choose not to be provided HCQ | 14 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete all study visits | 6 | 5 |
| Overall Study | Lost to Follow-up | 32 | 12 |
| Overall Study | Withdrawal by Subject | 10 | 16 |
Baseline characteristics
| Characteristic | Control Group | Total | HCQ Group |
|---|---|---|---|
| Age, Continuous | 43.7 years | 43.7 years | 43.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 47 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 9 Participants | 36 Participants | 27 Participants |
| Sex: Female, Male Female | 9 Participants | 28 Participants | 19 Participants |
| Sex: Female, Male Male | 5 Participants | 21 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 47 |
| other Total, other adverse events | 8 / 83 | 0 / 47 |
| serious Total, serious adverse events | 0 / 83 | 0 / 47 |
Outcome results
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.
Time frame: Baseline to 1 month post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HCQ Group | Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | 4 Participants |
| Control Group | Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month | 2 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).
Time frame: 4 Weeks Prior to Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HCQ Group | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | Symptomatic Seroconversion | 1 Participants |
| HCQ Group | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | Asymptomatic Seroconversion | 3 Participants |
| Control Group | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | Symptomatic Seroconversion | 2 Participants |
| Control Group | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion | Asymptomatic Seroconversion | 0 Participants |
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
Time frame: Day 90
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HCQ Group | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | with AEs Related to HCQ | 8 Participants |
| HCQ Group | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | with SAEs Related to HCQs | 0 Participants |
| Control Group | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | with AEs Related to HCQ | 0 Participants |
| Control Group | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time | with SAEs Related to HCQs | 0 Participants |