High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19

Sponsor
Marmara University
Study ID
NCT05133635
Phase
PHASE4
Status
Withdrawn

Conditions

  • COVID-19 Virus Infection
  • Corticosteroid
  • Cytokine Storm
  • Tocilizumab

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Methylprednisolone — DRUG
    Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
  • Tocilizumab — DRUG
    Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.

Study Details

COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc. One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc. In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.

Key Dates

Start date
Feb 1, 2021
Status verified
Nov 2021
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Pulse methylprednisolone
    250 mg methylprednisolone for 3 days
  • Active Comparator: Tocilizumab
    Tocilizumab 400-800 mg for one time

Primary Outcome Measure

Clinical condition [ Time Frame: Next 7 days of the intervention. ]

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