Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

• Status: Completed
• Trial end date: 2020-11-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bryn Mawr Hospital
• Collaborators: Bryn Mawr Hospital Foundation; Cotswold Foundation; Sharpe-Strumia Research Foundation
• Treatments: Hydroxychloroquine

Criteria

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