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NCT04333225

Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Completed Phase 2 Results posted Last updated 20 August 2021
What this trial tests

Phase 2 trial testing Hydroxychloroquine in COVID-19 in 221 participants. Completed in 30 June 2020.

Timeline
3 April 2020
Primary endpoint
30 June 2020
30 June 2020

Quick facts

Lead sponsorBaylor Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment221
Start date3 April 2020
Primary completion30 June 2020
Estimated completion30 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor Research Institute

Who can join

Adults 18 to 75, any sex, with COVID-19. 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 Infected With COVID-19 or COVID-19 Like Illness During the Trial Primary · Up to 7 weeks after study initiation

Number of participants infected with COVID-19 or identified as having COVID-19 like illness during the trial

GroupValue95% CI
Hydroxychloroquine13
Control32
Time From Study Initiation Until the Occurrence of COVID-19 or COVID-19 Like Illness or Being Censored Secondary · Up to 7 weeks after study initiation

Time-to-first clinical event consisting of a persistent change for any of the following: * diagnosis of COVID-19 * clinical characteristics of COVID-19 like illness * being censored

GroupValue95% CI
Hydroxychloroquine43.17± 11.15
Control39.25± 15.02

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hydroxychloroquine
Serious: 1/101 (1%)
Deaths: 0/101
Control
Serious: 0/120 (0%)
Deaths: 0/120

Serious adverse events (1 terms)

ReactionSystemHydroxychloroquineControl
COVID-19 like illnessInfections and infestations
Other adverse events (2 terms — click to expand)

ReactionSystemHydroxychloroquineControl
NauseaGastrointestinal disorders
DiarrheaGastrointestinal disorders

Most-reported serious reactions: COVID-19 like illness.

Data from ClinicalTrials.gov NCT04333225 adverse events section.

Sponsor's own description

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

Publications & conference data

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

  1. COVID-19: Characteristics and Therapeutics.
    Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
  2. 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
  3. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics.
    Arshad U, Pertinez H, Box H, Tatham L, et al · · 2020 · cited 115× · PMID 32438446 · DOI 10.1002/cpt.1909
  4. 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
  5. 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
  6. Potential therapeutic targets for combating SARS-CoV-2: Drug repurposing, clinical trials and recent advancements.
    Pandey A, Nikam AN, Shreya AB, Mutalik SP, et al · · 2020 · cited 80× · PMID 32497632 · DOI 10.1016/j.lfs.2020.117883
  7. Utilizing drug repurposing against COVID-19 - Efficacy, limitations, and challenges.
    Parvathaneni V, Gupta V. · · 2020 · cited 79× · PMID 32818545 · DOI 10.1016/j.lfs.2020.118275
  8. Tackling the cytokine storm in COVID-19, challenges and hopes.
    Abdin SM, Elgendy SM, Alyammahi SK, Alhamad DW, et al · · 2020 · cited 54× · PMID 32663575 · DOI 10.1016/j.lfs.2020.118054

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 Baylor Research Institute 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/NCT04333225.

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