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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

Sponsor
Bryn Mawr Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04652648
Collaborator
Sharpe-Strumia Research Foundation (Other), Bryn Mawr Hospital Foundation (Other), Cotswold Foundation (Other)
54
Enrollment
3
Locations
2
Arms
5.7
Actual Duration (Months)
18
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
May 27, 2020
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hydroxychloroquine

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

Drug: Hydroxychloroquine
Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days
No Intervention: Control

No Intervention

Outcome Measures

Primary Outcome Measures

  1. COVID-19 symptom development with positive PCR test [within 14 days]

    The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.

Secondary Outcome Measures

  1. Positive coronavirus PCR test without symptoms [By Day 14 (end of study)]

    Development of a positive coronavirus PCR test without symptoms by Day 14

  2. Hospital admission for COVID-19 [within 14 days of study entry]

    hospital admission for COVID-19 symptoms by Day 14

  3. Death by Day 14 [within 14 days of study entry]

    Death due to COVID-19 within 14 days of study entry

  4. HCQ discontinuation or study withdrawal [within 14 days of study entry]

    All-cause discontinuation of study medication or study withdrawal by Day 14

  5. Symptom severity at specified time points [at Day 7 and at Day 14 from study entry]

    overall symptom severity at Day 7 and Day 14

  6. COVID -19 rate at study entry [Day 1 of study]

    household attack rate at study entry

  7. EKG changes during study [Day 1 thru Day 14 of study]

    documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
2 Paoli Hospital Paoli Pennsylvania United States 19301
3 Lankenau Medical Center Wynnewood Pennsylvania United States 19096

Sponsors and Collaborators

  • Bryn Mawr Hospital
  • Sharpe-Strumia Research Foundation
  • Bryn Mawr Hospital Foundation
  • Cotswold Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Luciano kapelusznik, Attending Physician, Bryn Mawr Hospital
ClinicalTrials.gov Identifier:
NCT04652648
Other Study ID Numbers:
  • BM02332
First Posted:
Dec 3, 2020
Last Update Posted:
Dec 3, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
COVID-19
Coronavirus Infections
Hydroxychloroquine

Study Results

No Results Posted as of Dec 3, 2020