Enlivex Therapeutics reported the first two patients have been dosed in an investigator-initiated Phase II clinical trial evaluating Allocetra in severe and critical COVID-19 patients.

This COVID-19 study is designed as a multi-center, investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition and is designed to assess Allocetra in combination with standard of care treatment. The trial plans to evaluate safety, tolerability, cytokine profile and efficacy parameters. Each patient in the clinical trial will be observed for 28 days following administration of Allocetra.

The newly initiated Phase II study follows recently reported positive top-line results from a Phase Ib investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe and critical condition. The Phase Ib study took place in Hadassah Hospital and included five COVID-19 patients, three in severe condition and two in critical condition. All five patients completely recovered from their respective severe/critical condition and were released from the hospital after an average of five days (severe) and nine days (critical), following administration of Allocetra, at which time they were all COVID-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra in the patients, and the therapy was well-tolerated.

The COVID-19 study is a multi-center investigator-initiated, Phase II clinical trial. The trial is expected to recruit up to twenty-four COVID-19 patients in severe or critical condition, as defined by the U.S. National Institute of Health (NIH), and is designed to assess Allocetra in combination with standard of care treatment. Safety, tolerability, cytokine profile and efficacy parameters are planned to be evaluated. Up to twenty-four patients are expected to be recruited, subject to each patient’s eligibility and signing of an informed consent to participate and receive treatment. Eligibility criteria include an existing illness with at least one of (a) radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or (b) Sp/O2 ratio lower or equal to 94% on room air, or (c) requiring supplemental oxygen (low flow or high flow), with a P/F ratio of below 350 but higher than 150. Exclusion criteria include (a) pregnancy, lactation and childbearing potential woman who are not willing to use acceptable contraceptives measures for the entire study duration, (b) illness combined with other organ failure requiring organ support other than a respirator, including Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30), (c) intubated patients (due to inability to sign an informed consent), (d) patients with malignant tumor, other serious systemic diseases and psychosis, (e) patients who are participating in other clinical trials or treated with any experimental agents that may contradict this trial, (f) co-infection of HIV or tuberculosis, (g) known immunocompromised state or medications known to be immunosuppressive, and (h) patients with P/F ratio or S/F ratio of <150 or a change in status of eligibility manifested by a rapid decline of P/F ratio between eligibility status and actual drug delivery.