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NCT04318444

Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)

Terminated Phase 2, PHASE3 Results posted Last updated 25 September 2024
What this trial tests

Phase 2, PHASE3 trial testing Hydroxychloroquine in COVID-19 in 10 participants. Terminated before completion.

Timeline
29 March 2020
Primary endpoint
31 March 2021
31 March 2021

Quick facts

Lead sponsorColumbia University
PhasePhase 2, PHASE3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment10
Start date29 March 2020
Primary completion31 March 2021
Estimated completion31 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

18 and older, any sex, with COVID-19 or Corona Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Symptomatic, Lab-confirmed COVID-19. Primary · Date of enrollment to 14 days post-enrollment date

This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.

GroupValue95% CI
Hydroxychloroquine Group0
Placebo Group0

Sponsor's own description

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

Publications & conference data

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

  1. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
    Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
  2. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
    Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
  3. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs
    Tufan A, Avanoğlu Güler A, Matucci-Cerinic M. · · 2020 · cited 270× · PMID 32299202 · DOI 10.3906/sag-2004-168
  4. Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.
    Singh B, Ryan H, Kredo T, Chaplin M, et al · · 2021 · cited 140× · PMID 33624299 · DOI 10.1002/14651858.cd013587.pub2
  5. Hydroxychloroquine and COVID-19.
    Sinha N, Balayla G. · · 2020 · cited 107× · PMID 32295814 · DOI 10.1136/postgradmedj-2020-137785
  6. Multicenter Initial Guidance on Use of Antivirals for Children With Coronavirus Disease 2019/Severe Acute Respiratory Syndrome Coronavirus 2.
    Chiotos K, Hayes M, Kimberlin DW, Jones SB, et al · · 2020 · cited 91× · PMID 32318706 · DOI 10.1093/jpids/piaa045
  7. Therapeutic use of chloroquine and hydroxychloroquine in COVID-19 and other viral infections: A narrative review.
    Hashem AM, Alghamdi BS, Algaissi AA, Alshehri FS, et al · · 2020 · cited 85× · PMID 32387694 · DOI 10.1016/j.tmaid.2020.101735
  8. A systematic review of the prophylactic role of chloroquine and hydroxychloroquine in coronavirus disease-19 (COVID-19).
    Shah S, Das S, Jain A, Misra DP, et al · · 2020 · cited 76× · PMID 32281213 · DOI 10.1111/1756-185x.13842

Verify or expand the search:

Other trials of Hydroxychloroquine

Trials testing the same drug.

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Currently open trials in the same condition.

Other Columbia University trials

Trials by the same sponsor.

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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/NCT04318444.

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