Table 2 Inclusion and exclusion criteria for trial population

Inclusion criteria

1. History of confirmed (PCR or serology) SARS-CoV-2 infection according to WHO criteria

2. Ongoing symptoms of PCS for ≥ 3 months

3. Self-reported predominant cognitive deficits at screening

4. Male or female adult who is 18 years or older at the time of informed consent

5. Subject is willing, understanding, and able to provide informed consent

6. Signed informed consent prior to initiation of any trial related measure

7. For female subject or diverse subjects:

 (a) Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or

 (b) 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%):

 (a) combined (oestrogen and progestogen containing) hormonal

 (b) contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or

 (c) progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or

 (d) Intrauterine device, or

 (e) Intrauterine hormone-releasing system, or

 (f) Bilateral tubal occlusion, or

 (g) Vasectomised partner, or

 (h) Heterosexual abstinence

Exclusion criteria

1. Any ongoing central nervous system disease

2. Any major psychiatric disease within the last 10 years

3. Previous medical history of gastric ulcer, osteoporosis and/or previous vertebral fractures, rheumatological disease or metabolic disease including diabetes mellitus

4. Ongoing immunosuppressive therapy

5. Patient is pregnant or breastfeeding at screening

6. MMQ memory satisfaction subdomain > 50 points at Screening

7. Current malignant disease (including space-occupying brain tumours)

8. Body weight < 45 kg

9. Severe lactose intolerance

10. 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

11. Patient is institutionalized by order of court or public authority

12. Patient who might be dependent on the sponsor, the investigator or the trial site

13. Place of living does not allow the subject to attend the planned study visits

14. Other conditions that are likely to affect the safety of the study treatment (e.g., severely impaired immune status)

Additional exclusion criteria for MRI assessments

1. Pacemaker

2. Metal implants and other objects that are not proven MRI safe (e.g., drug pumps, heart valves, shards, joint prosthesis, hearing aids, stents)