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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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ClinicalTrials.gov Identifier: NCT04652648
Recruitment Status : Completed
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Sharpe-Strumia Research Foundation
Bryn Mawr Hospital Foundation
Cotswold Foundation
Information provided by (Responsible Party):
Luciano kapelusznik, Bryn Mawr Hospital

Study Description
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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
Covid19 Hydroxychloroquine Coronavirus Infection Transmission Prophylaxis Drug: Hydroxychloroquine 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
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Study Type : Interventional  (Clinical Trial)
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 : October 31, 2020
Actual Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Hospital admission for COVID-19 [ Time Frame: within 14 days of study entry ]
    hospital admission for COVID-19 symptoms by Day 14

  3. Death by Day 14 [ Time Frame: within 14 days of study entry ]
    Death due to COVID-19 within 14 days of study entry

  4. 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

  5. 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

  6. COVID -19 rate at study entry [ Time Frame: Day 1 of study ]
    household attack rate at study entry

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652648


Locations
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United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Paoli Hospital
Paoli, Pennsylvania, United States, 19301
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Bryn Mawr Hospital
Sharpe-Strumia Research Foundation
Bryn Mawr Hospital Foundation
Cotswold Foundation
More Information
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Publications:

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Responsible Party: Luciano kapelusznik, Attending Physician, Bryn Mawr Hospital
ClinicalTrials.gov Identifier: NCT04652648    
Other Study ID Numbers: BM02332
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
 Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents