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NCT04652648

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

Completed Phase 4 Last updated 3 December 2020
What this trial tests

Phase 4 trial testing Hydroxychloroquine in Covid19 in 54 participants. Completed in 15 November 2020.

Timeline
27 May 2020
Primary endpoint
31 October 2020
15 November 2020

Quick facts

Lead sponsorBryn Mawr Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment54
Start date27 May 2020
Primary completion31 October 2020
Estimated completion15 November 2020
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bryn Mawr Hospital

Who can join

18 and older, any sex, with Covid19 or Hydroxychloroquine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  2. Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic.
    Liu HH, Ezekowitz MD, Columbo M, Khan O, et al · · 2022 · cited 10× · PMID 34037911 · DOI 10.1007/s10840-021-00989-x
  3. The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic.
    Liu HH, Ezekowitz MD, Columbo M, Khan O, et al · · 2021 · cited 4× · PMID 34493311 · DOI 10.1186/s13063-021-05537-6

Verify or expand the search:

Other trials of Hydroxychloroquine

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04652648.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing