Trial · NCT05986422
Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
NCT05986422, Phase 2, Terminated, Charite University, Berlin, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS). Trials, record NCT05986422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05986422
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
- NCT number
- NCT05986422
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Charite University, Berlin, Germany
- Conditions
- Post-COVID-19 Syndrome
- Interventions
- Methylprednisolone
- First posted
- 2023-08-14
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in memory satisfaction as measured by the Multifactorial Memory Questionnaire (MMQ) | 8 weeks after first IMP intake | The MMQ is a participant-reported measure of memory satisfaction. It consists of three scales measuring separate aspects of metamemory including memory satisfaction, memory ability, and memory strategy. For memory satisfaction, eighteen items are rated on a 5-point Likert scale based on the test taker's experience over the previous two weeks.The score range is 0 to 72, with higher scores indicating a higher degree of satisfaction. A change of 13 points is commonly rated as clinically significant change. In this study, intra-patient change in MMQ subdomain memory satisfaction by ≥15 points from baseline to week 8 will be interpreted as meaningful improvement. |
| Secondary | Long-term improvement in memory satisfaction as measured by the Multifactorial Memory Questionnaire (MMQ) | 20 and 52 weeks after first IMP intake | Intra-patient change in MMQ subdomain memory satisfaction from baseline to week 20, from week 8 to week 20 and from week 20 to week 52 will be documented. |
| Secondary | Improvement in memory ability and memory strategy as measured by the Multifactorial Memory Questionnaire | 8 and 20 weeks after first IMP intake | As secondary outcomes the MMQ subdomains memory ability and memory strategy are assessed. The memory ability subscale evaluates participants' self-perception of everyday memory capabilities. Participants are asked to rate the frequency with which they experience 20 common memory mistakes over the preceding two weeks. Scores on this subscale range from 0 to 80, where higher scores indicate better self-reported memory ability. The memory strategy subscale evaluates the usage of practical memory strategies and aids in day-to-day life. Respondents rate the frequency of their utilization of 19 memory strategies during the past two weeks. Scores on this subscale range from 0 to 76, with higher scores reflecting a greater implementation of memory strategies. Mean difference in MMQ subdomain 'memory ability' and 'memory strategy' from baseline to week 8 and to week 20 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in neurocognitive functions as measured by the Montreal Cognitive Assessment (MoCA) | 8 and 20 weeks after first IMP intake | The MoCA is a sensitive and validated cognitive screening tool to test subjects quickly and accurately for mild cognitive impairment, irrespective of etiology. A person can gain a maximum of 30 points, and professionals consider a score of 26 or above to be normal. A score of 25 points or less may indicate some degree of cognitive impairment (18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment, fewer than 10 points = severe cognitive impairment). Intra-patient change in neurocognitive functions from baseline to week 8 and to week 20 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in neurocognitive functions as measured by the symbol digit modalities test (SDMT) | 8 and 20 weeks after first IMP intake | The SDMT (oral version) detects cognitive impairment in less than five minutes and will be used to assess change in cognitive function over time. SDMT is a validated and established measure of cognition in multiple sclerosis capturing impairments such as processing speed and working memory, visual search and scanning, and oculomotor functioning. Patients are provided a sheet with nine symbols, each paired with a number on top of the page. The remainder of the page consists of a randomized, sequential assortment of these symbols. Participants are asked to respond verbally with the number corresponding to each symbol. The final score is the correct number of substitutions in 90s (range 0 to 110, higher score = higher neurocognitive function). Intra-patient change in neurocognitive functions from baseline to week 8 and to week 20 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in quality of life (QoL) as measured by the PROMIS questionnaire | 8, 20, and 52 weeks after first IMP intake | The PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures can be used with the general population and with individuals living with chronic conditions. Intra-patient change in PROMIS score from baseline to week 8, week 20, and week 52 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale | 8, 20, and 52 weeks after first IMP intake | The Chalder Fatigue Scale measures the extent and severity of tiredness and has been used in multiple randomized trials of behavioral interventions in patients with ME/CFS. Each of the 11 items is answered on a 4-point scale with an overall score ranging from 0 (asymptomatic) to 33 (maximum symptomology). Intra-patient change in physical and mental fatigue from baseline to week 8, week 20, and week 52 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in fatigue as measured by the Fatigue Severity Score (FSS) | 8, 20, and 52 weeks after first IMP intake | The FSS is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle. Answers are scored on a seven-point scale (1 = strongly disagree; 7 = strongly agree). Thus, the minimum score is 9 (no fatigue), and the highest is 63 (heavy fatigue). Intra-patient change in fatigue severity from baseline to week 8, week 20, and week 52 and from week 8 to week 20 will be documented. |
| Secondary | Improvement in mood as measured by the Becks Depression Inventory (BDI-II) | 8, 20, and 52 weeks after first IMP intake | The BDI-II is a widely used self-report questionnaire designed to assess the severity of depression symptoms in individuals aged 13 years and older. It consists of 21 multiple-choice items, each corresponding to a specific symptom of depression. Respondents rate the intensity of their symptoms on a scale ranging from 0 to 3, with higher scores indicating greater levels of depression. Intra-patient change in mood from baseline to week 8, week 20, and week 52 and from week 8 to week 20 will be documented. |
| Secondary | Difference of occurring AE and SAE comparing Methyprednisolone with placebo (IMP safety). | 8 and 20 weeks after first IMP intake | Occurrence of IMP side and adverse effects, including but not limited to infections, endocrinologic disorders, and psychiatric complications, assessed with AE, SAE and SUSAR reports. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05986422
GET https://conductscience.org/api/trials/v1/NCT05986422/registered