Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
Completed · Phase 4
Conditions studied: Covid19, Hydroxychloroquine, Coronavirus Infection, Transmission, Prophylaxis
In brief
* 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
Key facts
- Study ID
- NCT04652648
- Run by
- Bryn Mawr Hospital
- People needed
- 54
- Starts
- 2020-05-27
- Expected to finish
- 2020-11-15
- Last updated by the study team
- 2020-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States
- Paoli Hospital — Paoli, Pennsylvania, United States
- Lankenau Medical Center — Wynnewood, Pennsylvania, United States
Full record on ClinicalTrials.gov
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