Zydus Cadila Covid therapy PegiHep completes Phase II trial
Ahmedabad: Zydus Cadila, has recently announced that the company has successfully completed a Phase 2 clinical trial in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHep'.
In this open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHep along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative.
In the test arm 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc. The study established the early safety, efficacy and tolerability of PegiHep in moderate COVID-19 patients.
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