Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652648
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-12-02
Brief Title:
Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
Sponsor:
Bryn Mawr Hospital
Organization:
Bryn Mawr Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None