NCT05986422TerminatedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 5 May 2026
Reason given: Following a recommendation from the Data Safety Monitoring Board (DSMB).
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 9 Aug 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 14 Mar 2025
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05986422
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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%)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.