06 Sep 2020
Posted in Pharma
Brazil’s high COVID-19 case count allows for clinical trials to progress, says GlobalData
While the COVID-19 pandemic continues to cause high numbers of confirmed new cases in Brazil, the patient population available for the increasing number of COVID-19 clinical trials should allow these to continue to completion, says GlobalData, a leading data and analytics company.
Scotty Chung-Siu, MPH, Senior Analyst at GlobalData, comments: “The number of COVID-19 cases in Brazil has been on a steady increase since the beginning of April, hitting a peak high of confirmed new cases in early August. Because of this, the number of COVID-19 clinical trials with a location in Brazil has also been increasing, with a marked steep incline since the beginning of June.”
As of the end of August, there were 91 clinical trials with at least one location in Brazil. The majority are currently ongoing (72%), followed by planned (16.5%), completed (6.6%) and suspended/terminated/withdrawn with 4.4%. Of those trials that have been suspended/terminated/withdrawn, three-quarters involved hydroxychloroquine as a primary intervention.
Chung-Siu continues: “The country’s president, Jair Bolsonaro, is a vocal advocate of hydroxychloroquine and the drug was approved for widespread use across the country by the Health Minister in May for COVID-19. Therefore, it is not surprising that 10.8% of planned and ongoing trials include hydroxychloroquine as a primary intervention.”
Eight clinical trials are in the pivotal/registration stage, the final step before regulatory approval, assuming endpoints are met. These include two targeted therapies, tocilizumab and lenzilumab, as well as three small molecules, including remdesivir.
The other three trials that are in the pivotal/registration stage are for vaccines. Two are for mRNA vaccines, BNT-162b1 and BNT-162b2, from BioNTech. The other one is for an inactivated vaccine, PiCoVacc, from Sinovac Biotech. On August 18, Brazil approved human clinical trials for Ad26.COV2.S, a potential prophylactic COVID-19 vaccine that is being developed by Johnson & Johnson’s subsidiary Jensen. The Phase III trial will enroll 60,000 patients, with 6,000 expected from Brazil.