Methylprednisolone for cognitive deficits in post-COVID-19 syndrome
Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients with Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
This study is testing if Methylprednisolone can help improve memory, mood, and overall quality of life for people dealing with cognitive issues after having COVID-19.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 418 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05986422 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Methylprednisolone, an immunosuppressant, on cognitive deficits in patients suffering from post-COVID-19 syndrome (PCS). It aims to determine whether this medication can improve memory function, fatigue, mood, and overall quality of life compared to a placebo. Participants will be randomly assigned to receive either Methylprednisolone or a matching placebo for six weeks, followed by a 52-week observation period to assess outcomes and side effects. The study will also stratify participants based on age, sex, and cognitive screening results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed history of COVID-19 and ongoing cognitive deficits for at least three months.
Not a fit: Patients with ongoing central nervous system diseases or major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients suffering from post-COVID-19 syndrome.
How similar studies have performed: While the approach of using Methylprednisolone for PCS is novel, other studies have explored immunosuppressants for similar conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Berlin
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Heinrich Audebert, Prof., MD — Charite University, Berlin, Germany
- Study coordinator: Christiana Franke, MD
- Email: christiana.franke@charite.de
- Phone: +49 30 450 560883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.