About the project
The majority of patients recover from a COVID-19 infection without any obvious sequelae, but a significant proportion suffer from long-term consequences known as Post-COVID syndrome (PCS). To date, there is no approved therapy and only the symptoms can be treated. The RAPID_ELAPSE study is investigating whether the drug bupropion helps to combat the severe exhaustion (fatigue) associated with post-COVID and improves the physical functioning of patients with post-COVID. To this end, the study compares the already approved drug with a placebo. The effect of bupropion has already been investigated in other diseases with severe fatigue and has helped many sufferers.
The most important facts at a glance
The main aim of the study is to find out what effect taking bupropion has on the severity of fatigue (fatique) and on the patients' general physical functioning at the end of taking the tablets compared to taking the placebo.
Other study objectives include determining the effect on physical functioning, the severity of fatigue, neuropsychiatric, respiratory and cognitive symptoms and physical performance.
In addition, biosamples will be taken for future patient stratification (categorisation of patients into homogeneous subgroups) and the safety and tolerability of bupropion in patients with PCS will be assessed.
The majority of patients recover from a COVID-19 infection without any obvious sequelae, but a significant proportion suffer from long-term consequences known as Post-COVID syndrome. These people have symptoms for months. The causes of this are not yet fully understood. The severity of the symptoms can range from only limited impairments in the private and professional environment to complete incapacity to work with a significantly reduced quality of life. To date, there is no authorised therapy and only the symptoms can be treated.
Realisation & project set-up
Note: This text is intended for medical personnel.
- Age: at least 18 years
- Patients with confirmed evidence of a SARS-CoV-2 infection at least 3 months ago and the presence of fatigue can participate.
Further inclusion criteria:
At least one other post-COVID symptom from the following list must apply:
- Shortness of breath or shortness of breath
- Limited physical resilience
- Cognitive impairment
- Post-exertional malaise (massive deterioration in health that occurs after physical, mental or emotional exertion)
- Moderate to severe physical impairment
- Symptoms have been present for at least 3 months and no other diagnosis has been found that better explains the symptoms present.
- Ability to understand and follow the nature of the study and associated procedures.
- Correct and consistent use of a highly effective contraceptive method during the study
There are further requirements for participation, which will be explained in a personal discussion between medical staff and patients. Possible participation in the study must always be checked in advance by the medical staff.
After checking the inclusion and exclusion criteria, the patients are randomly assigned to one of the two study groups (drug / placebo). In one group, the doctors administer drug treatment with the drug, while the other group receives drug treatment with a placebo. In both groups, information on the physical and cognitive condition is collected via questionnaires, tests and examinations.
Participation lasts about 3 months. A total of 5 personal appointments will take place at the trial centre. During this time, the medication/sham medication is taken daily for 56 days. Two weeks after starting the medication, a telephone call is made to the investigator. This is followed by three personal visits to the trial centre. One after 4 weeks, the second after 8 weeks and the last after 12 weeks. The visits to the trial centre include medical check-ups, the collection of questionnaires, blood samples and the distribution of study medication.
The study centres have not yet started recruitment. Please use the legend to find out whether a study centre is active.
A total of eleven trial centres from the following locations distributed throughout Germany will participate in the project: University Hospital Frankfurt, Charité University Hospital Berlin, Ludwig-Maximilians-University Munich, University Hospital Jena, University Hospital Göttingen, University Hospital Freiburg, University Hospital Schleswig-Holstein (Campus Kiel), University Hospital Cologne, University Hospital Würzburg, University Hospital Giessen and Marburg and University Hospital Heidelberg.
Further co-operation partners:
Sponsor: Goethe University Frankfurt
Coordinating study centre: University Medical Centre Göttingen
Other NUKLEUS partners: NUKLEUS CDM, EC, LIMS, RPA, THS and TO, NUM-MB BCU
Patients can participate in the RAPID_ELAPSE study if they are at least 18 years old, have post-COVID syndrome-associated fatigue and fulfil the other above-mentioned participation requirements. In this study, there are detailed guidelines as to which patients may participate in the study. Potential patients are therefore intensively examined in advance by a study doctor. A detailed informed consent discussion also takes place before enrolment in the study.
In the future, 11 locations in Germany will participate as shown on the map (see figure Study centres).
The use of all data and biomaterials collected in the study is subject to the strictest data protection guidelines. Each collection of data and biospecimens has been approved by an independent medical ethics committee. All data in the study that identifies individuals (name, date of birth, address, etc.) is encrypted. Individual patients are therefore not directly identifiable. All data is subject to the General Data Protection Regulation.
Subject insurance is also taken out for all participants in a clinical trial of a medicinal product.