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NCT04678739

Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

Completed Phase 3 Last updated 2 April 2021
What this trial tests

Phase 3 trial testing Remdesivir in Covid19 in 205 participants. Completed in 10 February 2021.

Timeline
15 August 2020
Primary endpoint
30 January 2021
10 February 2021

Quick facts

Lead sponsorM Abdur Rahim Medical College and Hospital
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment205
Start date15 August 2020
Primary completion30 January 2021
Estimated completion10 February 2021
Sites4 locations across Bangladesh

Drugs / interventions tested

Conditions studied

Sponsor

M Abdur Rahim Medical College and Hospital

Who can join

Adults 16 to 80, any sex, with Covid19 or Covid-19 ARDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

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. Remdesivir for the treatment of COVID-19.
    Ansems K, Grundeis F, Dahms K, Mikolajewska A, et al · · 2021 · cited 89× · PMID 34350582 · DOI 10.1002/14651858.cd014962
  3. Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
    Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
  4. Remdesivir for the treatment of COVID-19.
    Grundeis F, Ansems K, Dahms K, Thieme V, et al · · 2023 · cited 55× · PMID 36695483 · DOI 10.1002/14651858.cd014962.pub2
  5. 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
  6. 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
  7. 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
  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

Verify or expand the search:

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