* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Paoli Hospital
Paoli, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
COVID-19 symptom development with positive PCR test
The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
Time frame: within 14 days
Positive coronavirus PCR test without symptoms
Development of a positive coronavirus PCR test without symptoms by Day 14
Time frame: By Day 14 (end of study)
Hospital admission for COVID-19
hospital admission for COVID-19 symptoms by Day 14
Time frame: within 14 days of study entry
Death by Day 14
Death due to COVID-19 within 14 days of study entry
Time frame: within 14 days of study entry
HCQ discontinuation or study withdrawal
All-cause discontinuation of study medication or study withdrawal by Day 14
Time frame: within 14 days of study entry
Symptom severity at specified time points
overall symptom severity at Day 7 and Day 14
Time frame: at Day 7 and at Day 14 from study entry
COVID -19 rate at study entry
household attack rate at study entry
Time frame: Day 1 of study
EKG changes during study
documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy
Time frame: Day 1 thru Day 14 of study
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