Long Covid has quickly become an important area of public health and research that impacts an estimated 6% to 7% of adults worldwide. This condition includes a wide range of horrendous symptoms that can linger long after the initial Covid-19 illness has passed. A first of its kind clinical trial, designed to test a drug specifically to relieve these symptoms, has had a difficult go. It has ignited debate over the future of research in this space.
The Berlin Cures investigation aimed to understand the impact of BC 007 on patients coping with long Covid. After all, this drug was originally developed to treat chronic heart failure. At this point there were positive individual reports of symptom improvement, but by the end of the trial it failed to yield enough definitive results. Critics point out that the study does not differentiate between symptoms. They highlight how the design choice in the selection of participants led to its deficiencies. As millions more are likely to contend with the long-term challenges of long Covid, comprehension of the trial’s results and what comes next is key.
The Nature of Long Covid
Long Covid is an umbrella term for the diverse range of health complications that can arise after an infection with Covid-19. With symptoms ranging from fatigue and cognitive dysfunction to cardiac complications, it is a complex condition to research. As we have discussed, many researchers and advocates have noticed that long Covid is not just one disease. These illnesses have distinct clinical phenotypes or symptom patterns.
Emma, one of the participants in the Berlin Cures trial told her story with the drug. Though she experienced some positive changes post-infusion, she struggled to express her symptoms in survey responses.
“Honestly, I felt that there were zero precautions made and no consciousness present.” – Emma
The safety of conducting these trials is especially relevant for long Covid patients. From the start, participants have pressed medical facilities to adopt protective protocols. They particularly recommend requiring high-quality masks, because reinfection may make their symptoms even more severe. These calls to action highlight the critical requirement for education within the medical field. So here’s what we need to know about the complexities of long Covid.
The Berlin Cures Trial Experience
The Berlin Cures study only included people suffering from long Covid for less than a year. It eventually grew to include people who had experienced longer periods of suffering. The RCT included 119 participants, and another trial out of University Hospital Erlangen had just 30 participants enrolled. The Erlangen trial was great at picking the patients who would respond to the drug. First and foremost, it did an amazing job tracking their outcomes.
Participants such as Shayna Bhalla found their lives changed by having participated in the testifying trial. She recounted how she had a complete turnaround after the infusion.
“In the last few months, I have literally regained life,” – Bhalla
Some outcry grew, too, over what was being demanded of them in the trial. For Claudia, another participant, appointments required a full day’s effort and travel. This piled on even more stress for those who were already living with debilitating symptoms.
“Multiple people got screened at multiple screening sites multiple times,” – Claudia
The insight gained from participant experiences highlights the value of incorporating patient perspectives into the design and clinical execution of trials.
Lessons Learned and Future Directions
With challenges from the trials, researchers are still cautiously optimistic about future progress in treating long Covid. Dr. von Stein works with the Berlin Cures study. He was hopeful about lessons learned from this trial to inform the next phase of research efforts.
“Going forward now, the lessons learned here must be that we must pay great attention to the patient selection,” – von Stein
Helen Brownlie, a patient-researcher lying in wait collectively in the U.K. She warned that the Berlin Cures saga is a harsh reminder of failed—and traumatic—past clinical tries at ME. Testing BC 007 in people with long Covid will face serious hurdles. These challenges are reminiscent of the difficulties experienced by researchers studying complex chronic diseases in prepandemic times.
In closing, Dr. von Stein called for strong data collection in the future.
“The hope is maybe within 18 months … to have enough robust data that could form the basis of a registration study [Phase 3 trial],” – von Stein
This new emphasis on proactive data collection will be key in ensuring we do everything possible to bring the most effective treatments to market.
