Allocetra-OTS in COVID-19, Phase II

Summary

This is a multi-center, open-label study evaluating the safety of Allocetra-OTS, in up to 24 subjects with severe COVID-19 and respiratory dysfunction. Subjects, who will be identified as suffering from COVID-19, will be recruited. After signing an informed consent by the patient and, within 24+6 hours following the time of eligibility (time 0), on Day 1, eligible recipient subjects will receive single intravenous (IV) administration of investigational product as described below. Subjects will be hospitalized for COVID-19, and later as medically indicated. Following the investigational product (IP) administration (Day 1), subjects will be followed for efficacy and safety assessments through 28 days.

Timeline

Start

2020-10-20

Primary completion

2021-02

Completion

2021-03

Publications

• van Heerden PV, Abutbul A, Naama A, Maayan S, Makram N, Nachshon A, Abu Jabal K, Hershkovitz O, Binder L, Shabat Y, Reicher B, Mevorach D. Apoptotic cells for treatment of acute respiratory distress syndrome associated with COVID-19. Front Immunol. 2023 Aug 2;14:1242551. doi: 10.3389/fimmu.2023.1242551. eCollection 2023.

Drugs

Indications