PNB Vesper, a Kerala-based life sciences company, announced that it has successfully completed the phase 2 clinical trials of its proprietary drug PNB-001 (GPP-Baladol) on COVID-19 patients. The company had received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2 Clinical trial of GPP-BALADOL in COVID-19 moderate patients with oxygen support in September 2020. The clinical trial was initiated in November 2020 at BJ Government Medical College and Sassoon General Hospital Pune, and Victoria Medical College and Research Institute, Bangalore. The clinical trial report will now be submitted to DCGI on February 22, 2021.
The trial was conducted on 40 patients. The clinical trial protocol was designed in-line with the Solidarity Trial conducted by WHO and other international clinical trials. The primary objective of the clinical trial was to evaluate the overall efficacy of the drug in terms of outcomes such as changes from the baseline in the ordinal scale and mortality by day 28. The secondary objective was to evaluate the safety of GPP-Baladol in patients with moderate COVID-19 infection in terms of outcomes such as improvement in inflammatory segments in X-ray, duration of hospital stay, duration of assisted ventilation, improvement in oxygen saturation, number of days for a negative PCR result and change in inflammatory markers from baseline.