LSK Global Pharma Services said that it would conduct the phase 3 clinical trial of PiCoVacc, Sinovac Biotech’s Covid-19 vaccine candidate, in Bangladesh.

This clinical trial will involve about 4,200 frontline healthcare workers at seven hospitals in Dhaka, Bangladesh. According to the company, Bangladesh has the second-highest number of Covid-19 cases in Asia, with more than 300,000 confirmed cases so far.

"The seven hospitals chosen as clinical sites have focused on treating Covid-19 patients, leading to high rates of infection among health workers and further making it difficult to respond to the virus," the company said. "To reduce secondary infections among healthcare workers and prevent the spread of Covid-19 effectively, the trial participants will include doctors and nurses working at the hospitals."

LSK Global PS also stressed that due to concerns over Covid-19, the company would manage the trials remotely with non-contact interventions instead of taking the traditional site-centered approach.

"Procedures, including pre-tests, informed consent, and administration of the vaccine, are carried out face-to-face while online tools and an ePRO solution will be used for additional informed consent and reporting of the participants' health conditions," the company said. "Clinical data will be sent directly to LSK Global PS's database and monitored remotely without investigators having to visit the site through the use of an e-source data management tool."

According to the company, the advantage of non-contact clinical trials is that a high-quality patient-centered clinical trial can be conducted with reduced cost and time.

"We have prepared ourselves for non-contact clinical trials for years to reflect the changing clinical trial environment and believe that we are in good shape to complete this clinical trial successfully," CEO Lee Young-jak said.

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