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NCT05986422Leállítva2. fázis

Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)

Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 5.

Megadott ok: Following a recommendation from the Data Safety Monitoring Board (DSMB).

Rövid összefoglaló (regiszter, angolul)

This clinical trial aims to learn about the therapeutic value of Methylprednisolone, a well-known immunosuppressant, on cognitive deficits in patients with post-COVID-19 syndrome (PCS). The main questions it aims to answer are: 1) Does Methylprednisolone improve memory function in PCS patients compared to placebo? 2) Does Methylprednisolone improve other patient centered outcomes in PCS patients such as fatigue, mood and quality of life compared to placebo? 3)What are the side effects of Methylprednisolone in this patient population, and how common are they? Participants in this study will be patients with PCS and cognitive deficits, who will be asked to participate for 52 weeks. They will be randomly assigned to one of two groups: One group will receive Methylprednisolone once daily for six weeks, with a dosage reduction after week 4. The other group will receive a matching placebo once daily for six weeks, following the same titration regimen to ensure blinding. Participants will attend outpatient follow-up visits in weeks 8 and 20, with a final telephone follow-up after 52 weeks. Clinical examinations and safety monitoring will be conducted during the treatment phase. This study's results may help develop more effective therapies for this condition.

Állapot (regiszter)
Leállítva
Fázis (regiszter)
2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
96 (tényleges)
Első benyújtás
2023. aug. 9.
Kezdés
2023. okt. 1.
Elsődleges befejezés
2025. márc. 14.
Fő szponzor
Charite University, Berlin, Germany
NCT-szám
NCT05986422

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Korábbi kezelés

  • Previous medical history of gastric ulcer, osteoporosis and/or previous vertebral fractures, rheumatological disease or metabolic disease including diabetes mellitus
  • Ongoing immunosuppressive therapy
  • Participation in another clinical interventional trial within the last 3 months or five half- lives of the other trial's IMP, if longer than 6 months previous to informed consent

Más betegség

  • Any ongoing central nervous system disease
  • Any major psychiatric disease within the last 10 years
  • Current malignant disease (including space-occupying brain tumors)
  • Other conditions that are likely to affect to safety of the study treatment (e.g., severely impaired immune status)

Egyéb

  • Patient is pregnant or breastfeeding at screening
  • MMQ memory satisfaction subdomain >50 points at Screening
  • Body weight <45kg
  • Severe lactose intolerance
  • Patient is institutionalized by order of court or public authority
  • Patient who might be dependent on the sponsor, the investigator or the trial site
  • Place of living does not allow the subject to attend the planned study visits

Kiket keres a vizsgálat

  • History of confirmed (PCR or serology) SARS-CoV-2 infection according to WHO criteria
  • Ongoing symptoms of PCS for ≥ 3 months
  • Self-reported cognitive deficits at screening
  • Male or female adult who is 18 years or older at the time of informed consent
  • Subject is willing, understanding and able to provide informed consent
  • Signed informed consent prior to initiation of any trial related measure
  • For female subject or divers subjects:
    • Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
    • If being of childbearing potential:
    • Negative highly sensitive urine or serum pregnancy test before inclusion, and
    • Practicing a highly effective birth control method (failure rate of less than 1%)

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Charité Universitätsmedizin BerlinBerlinNémetországIsmeretlen állapot

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