Coronavirus Infection, Covid19, Hydroxychloroquine, Prophylaxis, Transmission
Conditions
Brief summary
* organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23 * Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25 * Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27 * Additional study using this technique is warranted to look at reliability and cost-28 effectiveness
Detailed description
Household members were contacted by telephone and provided consent forms via E-mail electronic signatures. Randomization was 2:1 to HCQ 200 mg BID or observation for 10 days with total follow-up of 14 days. COVID status was determined by home saliva PCR assay on days 1 and 14. Study drug was shipped to participants. Data of daily symptoms and 6-lead ECGs using a smartphone KardiaMobile® 6L application were collected.
Interventions
DRUGHydroxychloroquine
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days
Sponsors
Sharpe-Strumia Research Foundation
Bryn Mawr Hospital Foundation
Cotswold Foundation
Bryn Mawr Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* exposure to a COVID-19-infected individual in the same household within five days of diagnosis; * age \>18 years; * ability to give informed consent to participate in a clinical study; * ability to swallow oral medications; * access to a smartphone
Exclusion criteria
* allergy or intolerance to hydroxychloroquine (PlaquenilR); * weight less than 85 pounds; * eye disease affecting the retina; * severe kidney or liver disease; * G6PD-deficiency; * porphyria; * long QTc EKG abnormality or family history of this; * other major EKG abnormalities; * taking medications that can affect the QT interval including flecainide, amiodarone, digoxin, procainamide, propafenone, sotalol, quinidine, dofetilide, levofloxacin, ciprofloxacin, azithromycin, erythromycin, amitriptyline, doxepin, desipramine, imipramine, fluoxetine, sertraline, venlafaxine, quetiapine, haloperidol, droperidol, thioridazine, ziprasidone, furosemide, sumatriptan or zolmitriptan, cisapride, arsenic, dolasetron, or methadone; * current pregnancy; * current hospitalization; * symptomatic with fever or cough; * lack of access to a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 symptom development with positive PCR test | within 14 days | The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive coronavirus PCR test without symptoms | By Day 14 (end of study) | Development of a positive coronavirus PCR test without symptoms by Day 14 |
| Hospital admission for COVID-19 | within 14 days of study entry | hospital admission for COVID-19 symptoms by Day 14 |
| Death by Day 14 | within 14 days of study entry | Death due to COVID-19 within 14 days of study entry |
| EKG changes during study | Day 1 thru Day 14 of study | documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy |
| Symptom severity at specified time points | at Day 7 and at Day 14 from study entry | overall symptom severity at Day 7 and Day 14 |
| COVID -19 rate at study entry | Day 1 of study | household attack rate at study entry |
| HCQ discontinuation or study withdrawal | within 14 days of study entry | All-cause discontinuation of study medication or study withdrawal by Day 14 |
Countries
United States
Outcome results
None listed