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NCT04351620

High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

Completed Phase 1 Last updated 23 February 2023
What this trial tests

Phase 1 trial testing Hydroxychloroquine in COVID-19 in 12 participants. Completed in 10 June 2020.

Timeline
20 April 2020
Primary endpoint
10 June 2020
10 June 2020

Quick facts

Lead sponsorUniversity of Chicago
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date20 April 2020
Primary completion10 June 2020
Estimated completion10 June 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Chicago

Who can join

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

Sponsor's own description

This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.

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. A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.
    Tarighi P, Eftekhari S, Chizari M, Sabernavaei M, et al · · 2021 · cited 80× · PMID 33482181 · DOI 10.1016/j.ejphar.2021.173890
  4. Multicenter Interim 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 · · 2021 · cited 74× · PMID 32918548 · DOI 10.1093/jpids/piaa115
  5. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
    Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
  6. Hydroxychloroquine in COVID-19: Potential Mechanism of Action Against SARS-CoV-2.
    Satarker S, Ahuja T, Banerjee M, E VB, et al · · 2020 · cited 50× · PMID 32864299 · DOI 10.1007/s40495-020-00231-8
  7. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
    Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063
  8. The Molecular Basis of COVID-19 Pathogenesis, Conventional and Nanomedicine Therapy.
    Kouhpayeh S, Shariati L, Boshtam M, Rahimmanesh I, et al · · 2021 · cited 26× · PMID 34064039 · DOI 10.3390/ijms22115438

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Other trials of Hydroxychloroquine

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Other University of Chicago trials

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