Biophytis SA announced the recommendation by the Data Monitoring Committee (DMC) to continue patient recruitment into part 2 of the COVA study with the protocol unmodified after review of safety data. The independent DMC meeting was dedicated to the analysis of safety data from the first 155 patients randomized in the Phase 2-3 COVA Study in COVID-19. The efficacy data of those 155 patients will be reviewed by the DMC in Third Quarter 2021 as part of the second Interim analysis to make recommendation regarding futility and final sample size. As of now 191 patients have been randomized in 36 clinical centers opened in the USA, Brasil, France and Belgium. The COVA clinical program (clinicaltrials.gov identifier: NCT04472728) is a global, multicentric, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19. Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, and tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19. Part 2 of the COVA Study will be a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function of 310 or up to 465 COVID-19 patients (including the 50 patients from Part 1 of the study). The final sample size will depend upon DMC recommendations from the second interim analysis.