The Trial’s Flaws
However, the trial was flawed from the start, experts told The Sick Times. To select participants, the researchers used a blood test that was not validated for diagnosing long Covid or identifying autoantibodies blocking GPCRs. This meant that some participants may not have had the specific immune issues that BC 007 was designed to target, potentially diluting any positive effects.
Furthermore, the trial did not rigorously measure changes in symptoms or biological markers over time, making it difficult to determine if the drug was truly effective. Large clinical trials like this one typically have a control group, where some participants receive a placebo instead of the drug being tested, to ensure that any improvements are actually due to the treatment and not just the passage of time or a placebo effect. But the trial did not include a robust control group, making it hard to confidently attribute any symptom improvements to BC 007.
Fedorowski said that designing a successful long Covid trial requires a deep understanding of the disease’s complexity and tailoring interventions to specific symptoms and biological markers. Given the heterogeneity of long Covid, he said, a one-size-fits-all approach is unlikely to succeed.
Future Directions
Despite the setbacks with the Phase 2 trial, there may still be hope for BC 007 as a long Covid treatment. APTA Therapeutics, the new company formed by von Stein, plans to conduct further research on the drug in collaboration with experts in the field. The company will likely learn from the mistakes made in the previous trial and design future studies with more rigorous selection criteria and outcome measures.
Long Covid patients like Bhalla are hopeful that BC 007 will eventually become a viable treatment option. While the Phase 2 trial may have ended in disappointment, the research community is still actively searching for effective therapies for this debilitating condition. With continued research and collaboration, there is optimism that a treatment for long Covid will be found.
As for Bhalla, she remains determined to find relief from her long Covid symptoms. “I won’t stop fighting for a treatment that works for me,” she said. “I believe that one day, I will find something that helps me regain my full life back.”
By focusing on a more specific group of patients with long Covid and using validated criteria to select participants, the Erlangen trial was able to demonstrate more promising results for BC 007. This highlights the importance of proper patient selection and endpoint measurement in clinical trials, especially for complex diseases like long Covid.
Overall, the discrepancies between the two studies underscore the challenges in developing effective treatments for long Covid. While the Berlin Cures trial may have been hindered by unreliable tests, broad patient selection criteria, and inadequate endpoint measurement, the Erlangen trial was able to show positive outcomes by targeting a specific subgroup of patients and using validated criteria.
As research into long Covid continues, it will be crucial for future trials to learn from these experiences and implement more rigorous protocols for patient selection and outcome measurement. By doing so, researchers can improve the chances of finding effective treatments for this debilitating condition.
For patients like Claudia, Emma, and Lisa, the hope is that these lessons will lead to better treatments and ultimately improve the quality of life for those suffering from long Covid.
As for Berlin Cures, von Stein remains optimistic about the potential of BC 007 and the lessons learned from the trial. He emphasizes the importance of refining patient selection criteria and endpoints in future trials to ensure more meaningful clinical outcomes.
The researchers conducting a trial on BC 007, a potential treatment for long Covid, excluded individuals with documented organ damage from Covid-19. This decision was made based on studies suggesting that those with organ damage may represent a different subset of people with long Covid compared to those who meet the criteria for Myalgic Encephalomyelitis (ME).
Furthermore, the Erlangen trial implemented various symptom surveys, including some specifically designed and validated for individuals with ME. The results from these ME surveys indicated significant improvements when participants were treated with BC 007.
Since there are no validated instruments specific to long Covid, the researchers emphasized the importance of using multiple tests to capture a wide range of data. The Erlangen study utilized a crossover design, where all 30 patients received BC 007 at some point during the trial. This design allowed for a comprehensive evaluation of the drug’s effects.
Despite the transfer of Berlin Cures’ assets to APTA Therapeutics, von Stein, a key figure in the study, plans to conduct a more thorough analysis of the Phase 2 trial data. The goal is to publish this analysis in a scientific paper and potentially move towards a larger Phase 3 trial in the future.
One of the challenges faced by researchers in conducting these trials is securing funding. Von Stein expressed disappointment in the lack of financial support from governments, like Germany’s, despite the global impact of Covid-19.
Experts suggest that rigorous selection and stratification of participants are crucial in conducting clinical trials for complex chronic diseases like ME and long Covid. Helen Brownlie, a patient-researcher with ME, emphasized the need for trials to be designed in collaboration with individuals who have lived experience with the condition.
Clinical trials for ME and long Covid should focus on smaller, more targeted studies that match patients with specific biological profiles to treatments likely to benefit them. This approach allows for a more personalized and effective treatment strategy.
Patient-led groups, such as the Patient-Led Research Collaborative, have provided valuable insights and recommendations for conducting clinical trials for long Covid. They emphasize the importance of including patient feedback at all stages of the research process to ensure that studies are more effective and beneficial for those living with the condition. Emma, a participant in the Berlin Cures trial, believes that involving people with long Covid and ME/CFS directly in the planning stages of clinical trials is crucial. She argues that by including individuals who have first-hand experience with these chronic illnesses, the tools and methods used in the trials can better reflect the real-life challenges and experiences faced by patients.
On the other hand, Jakob, another participant in the trial, expressed his willingness to participate in future trials despite the challenges and disappointments he faced. He believes that taking part in clinical trials is essential in finding new medications and ultimately defeating these debilitating diseases.
Emma’s perspective highlights the importance of patient involvement in the research and development of treatments for long Covid and ME/CFS. By including individuals who understand the daily struggles and complexities of these illnesses, researchers can design more effective and patient-centered interventions.
Jakob’s willingness to participate in future trials underscores the urgency and necessity of finding new medications to treat long Covid and ME/CFS. Clinical trials provide researchers with valuable data and insights that can lead to breakthroughs in treatment options for these chronic conditions.
Overall, the voices of participants like Emma and Jakob remind us of the importance of patient-centered research and the role that individuals with lived experiences can play in shaping the future of healthcare. By listening to and involving patients in the planning and execution of clinical trials, we can ensure that the tools and methods used truly reflect the needs and challenges of those living with long Covid and ME/CFS.
