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NCT04643678

Anakinra in the Management of COVID-19 Infection

Completed Phase 2, PHASE3 Last updated 16 August 2022
What this trial tests

Phase 2, PHASE3 trial testing Anakinra in Covid19 in 80 participants. Completed in 30 April 2021.

Timeline
30 October 2020
Primary endpoint
1 March 2021
30 April 2021

Quick facts

Lead sponsorHamad Medical Corporation
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date30 October 2020
Primary completion1 March 2021
Estimated completion30 April 2021
Sites1 location across Qatar

Drugs / interventions tested

Conditions studied

Sponsor

Hamad Medical Corporation — full company profile →

Who can join

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

Sponsor's own description

Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.

Publications & conference data

8 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. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
    Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761
  3. NETosis and the Immune System in COVID-19: Mechanisms and Potential Treatments.
    Gillot C, Favresse J, Mullier F, Lecompte T, et al · · 2021 · cited 39× · PMID 34421600 · DOI 10.3389/fphar.2021.708302
  4. NLRP3 inflammasome activation in COVID-19: an interlink between risk factors and disease severity.
    Amin S, Aktar S, Rahman MM, Chowdhury MMH. · · 2022 · cited 37× · PMID 34838941 · DOI 10.1016/j.micinf.2021.104913
  5. Interleukin-1 blocking agents for treating COVID-19.
    Davidson M, Menon S, Chaimani A, Evrenoglou T, et al · · 2022 · cited 33× · PMID 35080773 · DOI 10.1002/14651858.cd015308
  6. IL-6 modulation for COVID-19: the right patients at the right time?
    Ascierto PA, Fu B, Wei H. · · 2021 · cited 33× · PMID 33837054 · DOI 10.1136/jitc-2020-002285
  7. Current evidence on the use of anakinra in COVID-19.
    Khani E, Shahrabi M, Rezaei H, Pourkarim F, et al · · 2022 · cited 31× · PMID 35905562 · DOI 10.1016/j.intimp.2022.109075
  8. Neurological complications associated with Covid-19; molecular mechanisms and therapeutic approaches.
    Mahboubi Mehrabani M, Karvandi MS, Maafi P, Doroudian M. · · 2022 · cited 29× · PMID 35138001 · DOI 10.1002/rmv.2334

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