The trial uses an adaptive trial design, so arms can open and close depending on interim data, Benfield said. The first interim check is scheduled after the first 75 patients are enrolled in each arm to check for safety, he noted. The second check is after 150 patients are enrolled in each arm, and will have involve a monitoring board looking into futility and whether the trial is powered enough to have a conclusion, he added.
If there is no second wave of COVID-19 infections in Denmark this fall, the trial could expand to other European countries like Norway and Sweden, Benfield added. At present, the trial is planned to have 12 sites in Denmark, which will slowly open in the next couple of months to accommodate training, he said. ClinicalTrials.gov shows the trial is not yet recruiting, with an estimated primary completion date of June 2021. The trial has a primary endpoint of all-cause mortality or need for invasive mechanical ventilation within a 28-day timeframe.
Denmark announced that it would enter lockdown on 11 March, even before the country had any deaths related to COVID-19, making it the second European country to implement this strategy. As of 23 April, there are 8,073 confirmed cases in Denmark, with 384 deaths, as per Johns Hopkins data. With lockdown measures slowly being eased, there is an expectation for COVID-19 cases to have a small increase over the next few weeks, especially in low socioeconomic areas where transmission risk can be higher, Benfield said.
by Reynald Castaneda in London
