Back to resultsRapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
Primary Purpose
Covid19, Hydroxychloroquine, Coronavirus Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional prevention trial for Covid19
Eligibility 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
Sites / Locations
- Bryn Mawr Hospital
- Paoli Hospital
- Lankenau Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Hydroxychloroquine
Control
Arm Description
Randomization was 2:1 to HCQ 200 mg BID for 10 days
No Intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Positive coronavirus PCR test without symptoms
Development of a positive coronavirus PCR test without symptoms by Day 14
Hospital admission for COVID-19
hospital admission for COVID-19 symptoms by Day 14
Death by Day 14
Death due to COVID-19 within 14 days of study entry
HCQ discontinuation or study withdrawal
All-cause discontinuation of study medication or study withdrawal by Day 14
Symptom severity at specified time points
overall symptom severity at Day 7 and Day 14
COVID -19 rate at study entry
household attack rate at study entry
EKG changes during study
documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy
Full Information
NCT ID
NCT04652648
First Posted
December 2, 2020
Last Updated
December 2, 2020
Sponsor
Bryn Mawr Hospital
Collaborators
Sharpe-Strumia Research Foundation, Bryn Mawr Hospital Foundation, Cotswold Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04652648
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bryn Mawr Hospital
Collaborators
Sharpe-Strumia Research Foundation, Bryn Mawr Hospital Foundation, Cotswold Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hydroxychloroquine, Coronavirus Infection, Transmission, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Randomization was 2:1 to HCQ 200 mg BID for 10 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days
Primary Outcome Measure Information:
Title
COVID-19 symptom development with positive PCR test
Description
The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
Time Frame
within 14 days
Secondary Outcome Measure Information:
Title
Positive coronavirus PCR test without symptoms
Description
Development of a positive coronavirus PCR test without symptoms by Day 14
Time Frame
By Day 14 (end of study)
Title
Hospital admission for COVID-19
Description
hospital admission for COVID-19 symptoms by Day 14
Time Frame
within 14 days of study entry
Title
Death by Day 14
Description
Death due to COVID-19 within 14 days of study entry
Time Frame
within 14 days of study entry
Title
HCQ discontinuation or study withdrawal
Description
All-cause discontinuation of study medication or study withdrawal by Day 14
Time Frame
within 14 days of study entry
Title
Symptom severity at specified time points
Description
overall symptom severity at Day 7 and Day 14
Time Frame
at Day 7 and at Day 14 from study entry
Title
COVID -19 rate at study entry
Description
household attack rate at study entry
Time Frame
Day 1 of study
Title
EKG changes during study
Description
documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy
Time Frame
Day 1 thru Day 14 of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Paoli Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts
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