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NCT04384380

Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19

Completed NA Last updated 4 August 2020
What this trial tests

NA trial testing Hydroxychloroquine Sulfate 200 MG [Plaquenil] in Coronavirus Infection in 33 participants. Completed in 31 May 2020.

Timeline
1 April 2020
Primary endpoint
31 May 2020
31 May 2020

Quick facts

Lead sponsorTaoyuan General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment33
Start date1 April 2020
Primary completion31 May 2020
Estimated completion31 May 2020
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Taoyuan General Hospital

Who can join

Adults 20 to 79, any sex, with Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effective medical treatment against COVID-19 infection is still unknown. Chloroquine phosphate is a well-known antimalarial drug which has been on the market for many years. Recently, in vitro study shown that Chloroquine is effective at both entry and at post-entry stages of the COVID-19 infection of Vero E6 cells with promising results. Chloroquine is also an immune-modifier and could distribute to the whole body including lung. Also, chloroquine is cheap and safe, and could be a promising agent against COVID-19 infection. However, only hydroxychloroquine (HCQ) with the extra hydroxyl group is available in Taiwan. Therefore, hydroxychloroquine instead become the best choice for the treatment candidate, since it shows higher in vitro potency (EC50) against COVID-19 with lower toxicity while retaining the original effect which compared with chloroquine.

Publications & conference data

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

  1. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.
    Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, et al · · 2021 · cited 217× · PMID 33859192 · DOI 10.1038/s41467-021-22446-z
  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 multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19).
    Chen CP, Lin YC, Chen TC, Tseng TY, et al · · 2020 · cited 67× · PMID 33264337 · DOI 10.1371/journal.pone.0242763
  4. Adverse effects of remdesivir, hydroxychloroquine and lopinavir/ritonavir when used for COVID-19: systematic review and meta-analysis of randomised trials.
    Izcovich A, Siemieniuk RA, Bartoszko JJ, Ge L, et al · · 2022 · cited 41× · PMID 35236729 · DOI 10.1136/bmjopen-2020-048502
  5. Systematic Review on the Therapeutic Options for COVID-19: Clinical Evidence of Drug Efficacy and Implications.
    Abubakar AR, Sani IH, Godman B, Kumar S, et al · · 2020 · cited 39× · PMID 33402839 · DOI 10.2147/idr.s289037
  6. 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
  7. Hydroxychloroquine and Covid-19: A Cellular and Molecular Biology Based Update.
    Pal A, Pawar A, Goswami K, Sharma P, et al · · 2020 · cited 20× · PMID 32641874 · DOI 10.1007/s12291-020-00900-x
  8. Efficacy and safety of chloroquine and hydroxychloroquine for treatment of COVID-19 patients-a systematic review and meta-analysis of randomized controlled trials.
    Eze P, Mezue KN, Nduka CU, Obianyo I, et al · · 2021 · cited 15× · PMID 33815925

Verify or expand the search:

Other trials of Hydroxychloroquine Sulfate 200 MG [Plaquenil]

Trials testing the same drug.

Other recruiting trials for Coronavirus Infection

Currently open trials in the same condition.

Other Taoyuan General Hospital trials

Trials by the same sponsor.

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