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NCT04600141: HEPMAB

Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection

Completed Phase 3 Last updated 18 March 2022
What this trial tests

Phase 3 trial testing Tocilizumab in Covid19 in 308 participants. Completed in 31 December 2021.

Timeline
10 November 2020
Primary endpoint
20 October 2021
31 December 2021

Quick facts

Lead sponsorUniversity of Sao Paulo
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment308
Start date10 November 2020
Primary completion20 October 2021
Estimated completion31 December 2021
Sites3 locations across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo

Who can join

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

Sponsor's own description

The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.

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. Immunotherapy of COVID-19: Inside and Beyond IL-6 Signalling.
    Zizzo G, Tamburello A, Castelnovo L, Laria A, et al · · 2022 · cited 55× · PMID 35340805 · DOI 10.3389/fimmu.2022.795315
  3. Anticoagulants for people hospitalised with COVID-19: a rapid review
    Flumignan RL, Civile VT, Tinôco JDS, Pascoal PI, et al · · 2022 · cited 41× · PMID 35244208 · DOI 10.1002/14651858.cd013739.pub2
  4. 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
  5. Peripheral T cell lymphopenia in COVID-19: potential mechanisms and impact.
    Zhang S, Asquith B, Szydlo R, Tregoning JS, et al · · 2021 · cited 31× · PMID 35965490 · DOI 10.1093/immadv/ltab015
  6. COVID-19 and venous thromboembolism: A narrative review.
    Angelini DE, Kaatz S, Rosovsky RP, Zon RL, et al · · 2022 · cited 24× · PMID 35224417 · DOI 10.1002/rth2.12666
  7. Mast cells: Therapeutic targets for COVID-19 and beyond.
    Lam HY, Tergaonkar V, Kumar AP, Ahn KS. · · 2021 · cited 17× · PMID 34467628 · DOI 10.1002/iub.2552
  8. D-Dimer Level and Neutrophils Count as Predictive and Prognostic Factors of Pulmonary Embolism in Severe Non-ICU COVID-19 Patients.
    Thoreau B, Galland J, Delrue M, Neuwirth M, et al · · 2021 · cited 16× · PMID 33926038 · DOI 10.3390/v13050758

Verify or expand the search:

Other trials of Tocilizumab

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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/NCT04600141.

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