MedTrace Logo

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

NCT04652648 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-12-03

No results posted yet for this study

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

Interventions

DRUG

Hydroxychloroquine

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

Sponsors & Collaborators

  • Sharpe-Strumia Research Foundation

    collaborator OTHER

  • Bryn Mawr Hospital Foundation

    collaborator UNKNOWN

  • Cotswold Foundation

    collaborator UNKNOWN

  • Bryn Mawr Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2020-10-31
Completion
2020-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652648 on ClinicalTrials.gov