Evidence map›Paper›PMID 34037911›Full record

Trial reportJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2022

Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic.

Hans H Liu, Michael D Ezekowitz, Michele Columbo, Oneib Khan, Jack Martin, Judith Spahr, David Yaron, Lisa Cushinotto, Luciano Kapelusznik

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04652648 (Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic), which is not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04652648 phase4completednot on this map

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

TypeinterventionalSponsorBryn Mawr HospitalRan2020 to 2020Enrolled54ConditionsCovid19, Hydroxychloroquine, Coronavirus Infection, TransmissionArmsHydroxychloroquine
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Observational
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Hans H LiuDepartment of Medicine, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Michael D EzekowitzDepartment of Medicine, Bryn Mawr Hospital, Bryn Mawr, PA, USA. ezekowitzm@mlhs.org.ORCID http://orcid.org/0000-0003-3623-2252
Michele ColumboDepartment of Medicine, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Oneib KhanLankenau Internal Medicine Residency Program, Lankenau Hospital, Main Line Health System, Wynnewood, PA, USA.
Jack MartinDepartment of Medicine, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Judith Spahr, Lewes, DE, USA.
David YaronBryn Mawr Family Practice Residency, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Lisa CushinottoDepartment of Pharmacy, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Luciano KapelusznikDepartment of Medicine, Bryn Mawr Hospital, Bryn Mawr, PA, USA.
Bryn Mawr Hospital · USLewes Victoria Hospital · GBMain Line Health · US

Funding

Sharpe Strumia Foundation 2020-01
6 · The paper itself

Abstract

backgroundThe coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application.

methodsTo reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily.

resultsFifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations.

conclusionsA clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. CLINICAL

trial registrationClinicaltrials.gov : NCT04652648 registration date: December 3, 2020.

Indexed as

COVID-19PandemicsElectrocardiographyFeasibility StudiesHumansProspective StudiesSARS-CoV-2Treatment OutcomeCOVID-19EKG monitoringHydroxychloroquineProspective trialSARS-CoV-2

Identifiers

PMID34037911
PMCPMC8149293
OpenAlexW3164730025

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.