A trial to find the effect of Ginkgo biloba extract EGb 761® and how safe it is in participants with cognitive impairment associated with post COVID-19 syndrome

Trial details

Who runs it

Dr. Willmar Schwabe GmbH & Co. KG

Trial code

EU 2024-517199-39-00

Record updated

2026. június 22.

Original description

To evaluate the effect of EGb 761® (240mg QD) compared to placebo on objective cognitive outcomes in participants with cognitive impairment associated with PCSRead full original descriptionShow less

A RANDOMIZED, PLACEBO-CONTROLLED, TRIPLE-BLIND CLINICAL TRIAL TO INVESTIGATE TREATMENT EFFECTS AND SAFETY OF GINKGO BILOBA EXTRACT EGB 761® IN PARTICIPANTS WITH COGNITIVE IMPAIRMENT ASSOCIATED WITH POST-COVID-19 SYNDROME

To evaluate the effect of EGb 761® (240mg QD) compared to placebo on objective cognitive outcomes in participants with cognitive impairment associated with PCS

Inclusion: Male or female outpatient, aged ≥18 years at the time of signing the ICF; Diagnosis of PCS based on the World Health Organisation (WHO) definition, requires a history of probable or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and PCS continuing at least beyond 3 months from the onset of coronavirus disease (COVID-19) symptoms. Symptoms should last for at least 2 months and cannot be explained by an alternative diagnosis; symptoms have an impact on everyday functioning, as indicated by a physician-rated post COVID functional status scale (PCFSS) score between 2 and 4; symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness, and they may fluctuate or relapse over time; History of probable or confirmed SARS-CoV-2 infection, confirmed by at least one of the following: positive polymerase chain reaction (PCR) test at the time of infection, positive antigen test at the time of infection along with clinical or epidemiological criteria, physician’s diagnosis based on a positive PCR or antigen test along with clinical or epidemiological criteria, presence of immunoglobulin G-antibody to the viral nucleocapsid antigen (anti-N IgG) antibodies, or presence of immunoglobulin G antibody to the viral spike antigen (anti-S IgG) antibodies in unvaccinated participants; Presence of persisting subjective cognitive problems for at least 2 months, associated with PCS and arising after the SARS-CoV-2 infection; Objective cognitive impairment, defined as deficits in at least one of the following 2 domains of cognition: memory (assessed by the California Verbal Learning Test [CVLT], long delay-free recall, below the 50th percentile for age and education) and executive functioning (assessed by the Trail-Making Test part B (TMT)-B, below the 50th percentile for age and education); Concomitant mild to moderate anxiety or depressive symptoms, defined as a Generalized Anxiety Disorder-7 (GAD-7) score between 5 to 14 and/or Patient Health Questionnaire-9 (PHQ-9) score between 5 to 19.

Exclusion: Participants who required mechanical ventilation at an intensive care unit during the acute SARS CoV 2 infection; Presence of haemorrhagic diatheses, coagulation disorder, gastric or duodenal ulcer; Presence of acute or chronic neurologic diseases within the last 12 months, such as stroke, transient ischemic attack (TIA), Parkinson’s disease, Alzheimer’s disease, seizure disorders, craniocerebral trauma, brain haemorrhage, multiple sclerosis, or cognitive impairment or dementia before acute COVID-19; Presence of acute or chronic psychiatric diseases within the last 12 months, including severe depression (PHQ-9 ≥20), severe anxiety (GAD-7 ≥15), significant primary sleep disorder, attention deficit hyperactivity disorder, bipolar disorder, substance use disorders, addictive behaviours, or schizophrenia. Mild to moderate psychiatric symptoms triggered by the SARS-CoV-2 infection will be allowed; Presence of severe or unstable internal disorders, such as cancer (with exceptions), active bacterial infections or known HIV infection, uncontrolled diabetes mellitus, uncontrolled arterial hypertension, known cardiac arrhythmia (Lown-classification IVb and V), heart failure NYHA III or IV, severe coronary heart disease, unstable angina pectoris, recent heart attack within last 6 months; History of postexertional malaise (PEM) persisting a week or longer in response to an exertion comparable to the planned site visits within the last 8 weeks; Intake of Ginkgo biloba products within the last 12 weeks.

EU CTIS 2024-517199-39-00