COVID-19
Conditions
Brief summary
The HCW Prophylaxis (HCWP) Study, single, open and off label intervention study. Up to 350 participants will be assigned to group that takes HCQ or group that opts to not take study medication. Participants will be UNM HEALTH SYSTEM HCW at high risk for occupational exposure to SARSCoV- 2. Study timepoints will include Day 1 screening/enrollment, 30 day, 60 day, and 90 day assessments. Questionnaires will be collected in all timepoints.
Detailed description
This is an open and off label use, interventional, single site study. The HCWP Study eligibility are HCWs at high risk for SARS-CoV-2 exposure (eg MD/DO, NP, RN, and respiratory therapists in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care and on Covid-19 units) at UNM HEALTH SYSTEM meeting all inclusion criteria. Total number of participants: 350 (Group A and B) Group A: up to 275 (HCW who choose to be provided HCQ). Will receive a 600 mg loading dose followed by 200 mg daily (tablets). Group B: up to 75 (HCW who choose not to be provided HCQ)
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets). Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily
Sponsors
University of New Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Men or women ≥18 years of age who are UNM HEALTH SYSTEM health care workers and are asymptomatic for known presenting symptoms of SARS-CoV-2: 2. UNMHS HCWs include: MD/DO, NP, RN, and respiratory therapists working in ED, Pediatric ED, Urgent Care, Pediatric Urgent Care or on Covid-19 units. Study PI's will consider study enrollment of HCWs from other settings, for example certain outpatient clinics or inpatient units. 3. Are not positive for SARS-CoV-2 testing 4. Willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures 5. Willing and able to provide informed consent
Exclusion criteria
1. Known hypersensitivity to HCQ or other 4-aminoquinoline compounds 2. Currently hospitalized 3. Symptomatic with subjective fever, cough, or sore throat 4. Current medications exclude concomitant use of HCQ, for example anti-arrhythmic agents, digoxin, cyclosporin, cimetidine, or tamoxifen. 5. Concomitant use of other anti-malarial treatment or chemoprophylaxis 6. History of retinopathy of any etiology 7. Psoriasis 8. Porphyria 9. Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes \<1500) or thrombocytopenia (\<100K) 10. Known liver disease 11. Known long QT syndrome 12. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period. There may be some exceptions to requiring a 30-day washout that will be evaluated by the Co-Investigators on a case by case basis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 Infection | 3 months | Number of health care workers who become infected with SARS-CoV-2 as detected by PCR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydroxychloroquine Arm Group A: 0 health care workers who choose to take hydroxychloroquine
Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria.
Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily | 0 |
| No Intervention Arm Group B: 1 health care workers who chose not to take hydroxychloroquine | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study stopped by DSMB | 0 | 1 |
Baseline characteristics
| Characteristic | No Intervention Arm | Total | Hydroxychloroquine Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
SARS-CoV-2 Infection
Number of health care workers who become infected with SARS-CoV-2 as detected by PCR
Time frame: 3 months
Population: DSMB stopped trial early prior to any data collection.