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NCT05133635
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
Phase 4 trial testing Methylprednisolone in COVID-19 Virus Infection. Withdrawn.
1 April 2021
Quick facts
| Lead sponsor | Marmara University |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Start date | 1 February 2021 |
| Primary completion | 1 April 2021 |
| Estimated completion | 1 April 2021 |
Drugs / interventions tested
- Methylprednisolone (methylprednisolone) — full drug profile →
- Tocilizumab (tocilizumab) — full drug profile →
Conditions studied
- COVID-19 Virus Infection — all drugs for COVID-19 Virus Infection →
- Cytokine Storm — all drugs for Cytokine Storm →
- Corticosteroid — all drugs for Corticosteroid →
- Tocilizumab — all drugs for Tocilizumab →
Sponsor
Marmara University
Who can join
Adults 18 to 70, any sex, with COVID-19 Virus Infection or Cytokine Storm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2 -
Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987
Verify or expand the search:
- PubMed search for NCT05133635
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05133635 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Marmara University
- Last refreshed: 24 November 2021
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/NCT05133635.
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