NCT04652648

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bryn Mawr Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19
• Hydroxychloroquine
• Coronavirus Infection
• Transmission
• Prophylaxis

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days

Timeline

• Start date: 2020-05-27
• Primary completion: 2020-10-31
• Completion: 2020-11-15
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study