We presented the rationale for the use of thymosin α1 as prophylaxis of severe COVID-19 in cancer patients undergoing active treatment, constituting the background for the PROTHYMOS study, a prospective, multicenter, open-label, Phase II randomized study, currently in its start-up phase (Eudract no. 2020-006020-13). We aim to offer new hope for this incurable disease, especially to frail patient population, such as patients with cancer. The hypothesis of an effective prophylactic approach to COVID-19 would have immediate clinical relevance, especially given the lack of curative approaches. Moreover, in the ‘COVID-19 vaccine race era’ both clinical and biological results coming from the PROTHYMOS trials could even support the rationale for future combinatorial approaches, trying to rise vaccine efficacy in frail individuals. Lay abstract We present scientific evidence in favor of using a drug (thymosin-α1) that modulates the immune system functions to try and prevent severe COVID-19 in cancer patients who are currently receiving anticancer treatment. Thymosin-α1 is produced normally by the body in the thymus, which is present in children but not in adults. Given the better outcomes of SARS-CoV-2 infections in children, we thought that thymosin-α1 could help to protect adults from severe infections as well. In this review, we explain some scientific evidence and the background of our clinical trial, PROTHYMOS, which is investigating this preventive treatment. Our aim is to offer a new hope to these at-risk cancer patients, particularly for the elderly who are at most risk of developing severe COVID-19. Given the lack of approaches that can provide cures to COVID-19, any possibility to prevent severe infection should be explored.
【저자키워드】 COVID-19, SARS-CoV-2, vaccination, prevention, Prophylaxis, Cancer patients, caner, 【초록키워드】 Treatment, Severe infection, Efficacy, Vaccine, clinical trial, Trial, Open-label, severe COVID-19, children, vaccine efficacy, risk, drug, immune system, outcome, Prophylactic, Prophylaxis, Adults, Cancer patients, multicenter, disease, function, Evidence, Hypothesis, phase, thymus, cancer patient, active treatment, incurable disease, preventive treatment, Support, Patients with cancer, Abstract, approaches, rationale, help, favor, randomized study, severe infections, EudraCT, anticancer, scientific evidence, patient population, offer, thymosin, approach, Prevent, effective, PROTECT, thought, produced, lack, approach, receiving, modulate, individuals, explain, incurable, curative, 【제목키워드】 cancer patient,