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

NCT04652648 | Completed Phase 4 FDA Drug

• 1 other identifier: BM02332
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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

Conditions

Covid19; Hydroxychloroquine; Coronavirus Infection; Transmission; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  within 14 days

Secondary Outcomes (7)

• Positive coronavirus PCR test without symptoms

  By Day 14 (end of study)

• Hospital admission for COVID-19

  within 14 days of study entry

• Death by Day 14

  within 14 days of study entry

• HCQ discontinuation or study withdrawal

  within 14 days of study entry

• Symptom severity at specified time points

  at Day 7 and at Day 14 from study entry

Study Arms (2)

Hydroxychloroquine

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine

Control

NO INTERVENTION

No Intervention

Interventions

Hydroxychloroquine DRUG

Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bryn Mawr Hospital: lead
• Sharpe-Strumia Research Foundation: collaborator
• Bryn Mawr Hospital Foundation: collaborator
• Cotswold Foundation: collaborator

Study Sites (3)

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Paoli Hospital

Paoli, Pennsylvania, 19301, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

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MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 3, 2020
• Study Start: May 27, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 15, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)