Brazilian health regulatory agency (ANVISA) authorizes Sorrento phase II clinical trial of COVI-MSC in COVID-19 patients with persistent pulmonary compromise after recovery (long-hauler).

Recent epidemiologic studies in the US and Britain cite that over 1 in every 3 COVID-19 patients might have lingering symptoms long past the time that they’ve recovered from the initial stages of COVID-19 illness. Often referred to as “Long COVID” syndrome, the symptoms in “long haulers” can include fatigue, shortness of breath, persistent cough, “brain fog”, sleep disorders, fevers, gastrointestinal symptoms, anxiety, and depression, and can persist for months and range in level of severity from mild to incapacitating. In some cases, new symptoms arise well after the time of infection or evolve over time. While still being defined, these effects can be collectively referred to as Post-Acute Sequelae of a SARS-CoV-2 infection.

The Brazil study is a Phase II, multi-center, randomized, controlled study to evaluate the safety and efficacy of up to three infusions of COVI-MSC , administered every other day, to patients experiencing respiratory difficulty recovering from a COVID-19 infection at least 3 months prior to enrollment. The study is expected to enroll 60 patients (in 4 dosing regimen cohorts) in about six months from the date of first enrollment. The primary outcome measure will be improvement in the 6-Minute Walk Distance (6MWD) test at Day 60 post-treatment.

Sorrento expects this projected pace of enrollment due to the prior extensive COVID-19 disease burden in Brazil, Sorrento’s partnership with a leading local clinical research organization (Synova Health), and existing relationships with high quality medical centers throughout the country. The current partnership with Synova Health leverages high quality clinical trial sites in addition to a dozen centers that have already participated in other acute COVID-19 studies with Sorrento (Abivertinib and MSC).

The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.986743/2021-44, Expediente 3229927/21-4 COMUNICADO ESPECIAL (CE) Nº 0001/22 – GSTCO/DIRE2/Anvisa.