Critical Path Institute, United States of America.
Harvard, United States of America.
Life Sci. 2024 Sep 15;353:122940. doi: 10.1016/j.lfs.2024.122940. Epub 2024 Aug 2.
Long COVID, a spectrum of symptoms and syndromes that can develop after SARS-COV-2 infection, can significantly affect patients' health, quality of life and impact their ability to productively function in society. There is currently no approved therapy for Long COVID and there is an urgent need for rigorous clinical trials to find such treatments. Although research into the pathophysiology of Long COVID is advancing, investigations into treatment for patients remain underfunded and, as a result, understudied. Owing to the urgency of the Long COVID pandemic and as a research collaborative across a diversity of biomedical innovation value propositions, we are calling for a new approach that parallelizes pathophysiologic and therapeutic research into this condition, leveraging patient-centered research and real-world data to generate hypotheses to assess the effectiveness of existing FDA approved drugs. Accelerated discovery of therapeutics for Long COVID can then be confirmed through efficient and cost-effective adaptive platform clinical trials.
长新冠,即感染 SARS-CoV-2 后出现的一系列症状和综合征,可能显著影响患者的健康、生活质量,并影响其在社会中正常生产生活的能力。目前尚无针对长新冠的获批疗法,因此急需开展严格的临床试验来寻找此类疗法。尽管长新冠的病理生理学研究正在取得进展,但针对患者的治疗研究资金仍然不足,因此研究也不够充分。鉴于长新冠大流行的紧迫性,并且作为一个跨多种生物医学创新价值主张的研究合作组织,我们呼吁采用一种新方法,将这种疾病的病理生理学和治疗研究并行推进,利用以患者为中心的研究和真实世界数据来生成假设,以评估现有 FDA 批准药物的有效性。然后,可以通过高效且具有成本效益的适应性平台临床试验来确认长新冠治疗药物的发现。