Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

December 2, 2020 updated by: Luciano kapelusznik, Bryn Mawr Hospital
  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 symptom development with positive PCR test
Time Frame: within 14 days
The primary endpoint was development of COVID-19 symptoms with a positive coronavirus PCR test by Day 14.
within 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive coronavirus PCR test without symptoms
Time Frame: By Day 14 (end of study)
Development of a positive coronavirus PCR test without symptoms by Day 14
By Day 14 (end of study)
Hospital admission for COVID-19
Time Frame: within 14 days of study entry
hospital admission for COVID-19 symptoms by Day 14
within 14 days of study entry
Death by Day 14
Time Frame: within 14 days of study entry
Death due to COVID-19 within 14 days of study entry
within 14 days of study entry
HCQ discontinuation or study withdrawal
Time Frame: within 14 days of study entry
All-cause discontinuation of study medication or study withdrawal by Day 14
within 14 days of study entry
Symptom severity at specified time points
Time Frame: at Day 7 and at Day 14 from study entry
overall symptom severity at Day 7 and Day 14
at Day 7 and at Day 14 from study entry
COVID -19 rate at study entry
Time Frame: Day 1 of study
household attack rate at study entry
Day 1 of study
EKG changes during study
Time Frame: Day 1 thru Day 14 of study
documentation of EKG changes such as QTc prolongation on HCQ compared with no drug therapy
Day 1 thru Day 14 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bryn Mawr Hospital

Collaborators

Sharpe-Strumia Research Foundation
Bryn Mawr Hospital Foundation
Cotswold Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM02332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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