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

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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:

1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or

2. If being of childbearing potential:

1. Negative highly sensitive urine or serum pregnancy test before inclusion, and

2. Practicing a highly effective birth control method (failure rate of less than 1%)

Exclusion Criteria:

• Any ongoing central nervous system disease

• Any major psychiatric disease within the last 10 years

• Previous medical history of gastric ulcer, osteoporosis and/or previous vertebral fractures, rheumatological disease or metabolic disease including diabetes mellitus

• Ongoing immunosuppressive therapy

• Patient is pregnant or breastfeeding at screening

• MMQ memory satisfaction subdomain >50 points at Screening

• Current malignant disease (including space-occupying brain tumors)

• Body weight <45kg

• Severe lactose intolerance

• 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

• 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

• Other conditions that are likely to affect to safety of the study treatment (e.g., severely impaired immune status)