COVID-19 related risk in patients enrolled in early-phase clinical trials

Background Early phase clinical trials often represent a therapeutical opportunity for cancer patients (pts). However, high logistic commitment is demanded for participation. Here we explore the COVID-19 related risk during the pandemic for pts enrolled in clinical trials compared to pts receiving standard treatments. Methods We retrospectively assessed the incidence of COVID-19 in pts treated in our Department from March 2020 to April 2021. Pts were divided into two groups; those enrolled in phase I/II clinical trials (A) and those being treated with standard therapies (B). Logistical (telemedicine and drug home-delivery), as well as clinical, characteristics of susceptibility to COVID-19 and number of events (SARS-CoV2 infections) were collected. The number of teleconsultations and COVID-19 events among the two groups were compared through Fisher’s exact test. Results 115 pts were evaluated: 36 pts (31%) in A and 79 pts (69%) in B. Pts in A were younger, with a median age of 55 years (range 39-77) compared to 62 years (range 31-83) in B. Performance status (PS, ECOG) was similarly distributed: 0 (A 78%, B 83%), 1-2 (A 22%, B 17%). The median of previous treatment was 1 in A (range 0-9) and 2 (range 0-14) in B. The majority of the pts had at least one comorbidity in both groups (A: 72% and B: 83%). None of the pts had pulmonary comorbidity in A and 6% in B. Obesity was similarly distributed (A 11%, B 14%). The mean of monthly scheduled accesses was 1,5 in both groups. However, teleconsultation and delivery of oral cancer treatments at home were given, at least on one occasion, to only 6% of pts in A compared to 43% in B (p<0.01). A total of 15 COVID-19 cases were observed (13%): 8 (22%) in A and 7 (8%) in B. No statistically significant difference was observed (p = 0.068). Conclusions Pts enrolled in early phase clinical trials had a significantly lower chance to perform teleconsultations compared to pts receiving standard therapy. Even if a trend was observed, they did not have a higher risk of contracting COVID-19. Future pts should then be encouraged to participate, if indicated. Considering the small numbers of pts in our cohorts, the foreseen trend toward a higher infection risk and the subsequent implications should be further explored in larger populations.