Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, placebo controlled, double-blind phase III trial with four parallel groups studying studying the feasibility of RCT in primary care as well as the effectiveness of treatment with prednisolone and/or vitamin B1/6/12 for PC19S.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuerzburg University Hospital
• Collaborators: University Hospital Schleswig-Holstein; University Hospital Tuebingen
• Treatments: Corticosterone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

1. adult patients (at least 18 years old)

2. history of documented SARS-CoV-2 infection at least 12 weeks ago

3. symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression

4. Above mentioned symptom(s) that developed during or after the SARS-CoV-2 infection, that persist until study inclusion, and that are associated with COVID 19 as assessed by the patients' general practitioner or the local investigator

Exclusion Criteria:

1. acute Coronavirus disease (COVID-19) at baseline visit

2. patients who were treated in the intensive care unit because of COVID-19

3. pregnancy/ breastfeeding

4. diabetes mellitus

5. hypertension

6. PC19S symptoms that can be explained by an alternative diagnosis

7. History of severe medical conditions such as

• concomitant acute infectious disease

• gastrointestinal ulcer

• liver disease/liver cirrhosis

• malabsorption or condition after bariatric surgery

• chronic airway disease

• chronic heart failure [New York Heart Association (NYHA) III and IV]

• neurological disorders

• untreated hypothyroidism

• significantly impaired glucuronidation

• immunodeficiency or a chronically weakened immune system

• mental disorders

• active cancer

• any other severe medical conditions that preclude participation as determined by responsible physician

8. current use of

• immunosuppressive drugs

• non-steroidal antiinflammatory drugs (NSAID)

• fluoroquinolones

• anticoagulation

• any other drug with a possible interaction with the study medication

9. current or previous systemic treatment with any of the treatment drugs for at least seven days since COVID-19 or any parenteral application

10. known allergy and contraindications to the intervention drugs

11. need of care and/or peer dependency

12. nursing home residents

13. inability to understand the scope of the study, to follow study procedures and to give informed consent or to attend the study sites

14. participation in another interventional trial at the same time or within the past 3 months before enrolment

15. female patients considering to get pregnant during the first month of the trial and within 1 week after the last dose of study drug(s)