Sorrento Therapeutics, Inc. announced receipt of clearance from the Brazilian regulatory agency to proceed with a PHASE 2A RANDOMIZED, PLACEBO-CONTROLLED STUDY OF INTRAVENOUS ALLOGENEIC ADIPOSE-DERIVED MESENCHYMAL STROMAL CELLS TO TREAT POST COVID-19 “LONG HAUL” PULMONARY COMPROMISE (NCT04992247). 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 2, 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 about six months from the date of first enrollment. The primary outcome measure will be improvement in the 6-Minute Walk Distance 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, 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.