COVID-19
Conditions
Keywords
hydroxychloroquine
Brief summary
In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.
Interventions
DRUGHydroxychloroquine
Weekly treatment in individuals at high risk
Sponsors
Baylor Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent 2. Healthcare workers with • One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit. OR • Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening. 3. Afebrile with no constitutional symptoms 4. Willing and able to comply with scheduled visits, treatment plan, and other study procedures 5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures
Exclusion criteria
1. Participation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days 2. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication 3. Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia 4. Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency 5. Having dermatitis, psoriasis or porphyria 6. Taking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate 7. Allergies: 4-Aminoquinolines 8. Pre-existing retinopathy of the eye 9. Has a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis 10. Untreated or uncontrolled active bacterial, fungal infection 11. Known or suspected active drug or alcohol abuse, per investigator judgment 12. Women who are pregnant or breastfeeding 13. Known hypersensitivity to any component of the study drug 14. A known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial | Up to 7 weeks after study initiation | Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored | Up to 7 weeks after study initiation | Time-to-first clinical event consisting of a persistent change for any of the following: * diagnosis of COVID-19 * clinical characteristics of COVID-19 like illness * being censored |
Countries
United States
Participant flow
Recruitment details
All study subjects were employed by and worked at the Baylor University Medical Center in Dallas, Texas.
Participants by arm
| Arm | Count |
|---|---|
| Hydroxychloroquine Subjects who chose to enter the HCQ arm received a loading dose of 800 mg HCQ on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks | 101 |
| Control Subjects who declined taking HCQ were considered as controls | 120 |
| Total | 221 |
Baseline characteristics
| Characteristic | Hydroxychloroquine | Control | Total |
|---|---|---|---|
| Age, Continuous | 39.90 Years STANDARD_DEVIATION 12.42 | 34.53 Years STANDARD_DEVIATION 800 | 35.36 Years STANDARD_DEVIATION 11.05 |
| Cough score | 2.74 Millimeters STANDARD_DEVIATION 7.66 | 3.26 Millimeters STANDARD_DEVIATION 7.46 | 3.02 Millimeters STANDARD_DEVIATION 7.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 26 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 94 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Others | 19 Participants | 12 Participants | 31 Participants |
| Race/Ethnicity, Customized White | 78 Participants | 104 Participants | 182 Participants |
| Region of Enrollment United States | 101 participants | 120 participants | 221 participants |
| Sex: Female, Male Female | 66 Participants | 101 Participants | 167 Participants |
| Sex: Female, Male Male | 35 Participants | 19 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 120 |
| other Total, other adverse events | 21 / 101 | 0 / 120 |
| serious Total, serious adverse events | 1 / 101 | 0 / 120 |
Outcome results
Primary
Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial
Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial
Time frame: Up to 7 weeks after study initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydroxychloroquine | Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial | 13 Participants |
| Control | Number of Participants Infected With COVID-19 or COVID-19 Like Illness During the Trial | 32 Participants |
p-value: 0.011295% CI: [1.15, 3.72]Chi-squared
Secondary
Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored
Time-to-first clinical event consisting of a persistent change for any of the following: * diagnosis of COVID-19 * clinical characteristics of COVID-19 like illness * being censored
Time frame: Up to 7 weeks after study initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored | 43.17 Days | Standard Deviation 11.15 |
| Control | Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored | 39.25 Days | Standard Deviation 15.02 |
p-value: 0.010595% CI: [0.17, 0.75]Log Rank