Trial | NCT04652648  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    54
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
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.
Study Started
May 27
2020
Primary Completion
Oct 31
2020
Study Completion
Nov 15
2020
Last Update
Dec 03
2020

Drug Hydroxychloroquine

Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days

Hydroxychloroquine Active Comparator

Randomization was 2:1 to HCQ 200 mg BID for 10 days

Control No Intervention

No Intervention

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
No Results Posted