Status:
RECRUITING
Methylprednisolone in Patients with Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Post-COVID-19 Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 quest...
Detailed Description
Around 10-40% of mild COVID-19 patients experience persisting or new symptoms known as post-COVID-19 syndrome (PCS). Neurological symptoms, particularly cognitive deficits and fatigue, are common in P...
Eligibility Criteria
Inclusion
- 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%)
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT05986422
Start Date
October 1 2023
End Date
December 31 2025
Last Update
February 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117