A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality.

Several clinical trials utilizing novel drugs and repurposing older agent have been implemented to investigate the treatment of adults hospitalized with severe COVID-19. There is evidence that the humoral immune responses are variable between individuals and delayed in some cases. It may therefore be that viral replication leads to extensive tissue damage and inflammatory responses in the lungs and other organs before the development of neutralizing antibodies. Augmentation of the humoral immune response to SARS-CoV-2 infection using passive immunotherapy in hospitalized patients may thus improve the disease course and reduce the time to recovery.

This study is an adaptive, randomized blinded controlled phase 2 trial to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection or directly enhancing viral control in order to limit disease progression.

This study is a multicenter trial that will be conducted in 16 countries and expected to enroll about 1012 subjects around the world.

All subjects will undergo a series of efficacy, safety and laboratory assessments. Discharged patients will attend study visits at Days 28 and 90 when blood samples are collected. Nasal swabs will be obtained on Day 0. Primary endpoint is defined as the time from randomization to sustained recovery, being discharged from hospitalization followed by being alive and home for 14 consecutive days prior to Day 90.

Though the agents studied may or may not prevent these outcomes in any participating individual, there is an anticipated benefit to society due to insights that will be gained about the investigational agent as well as the natural history of the disease, especially if a safe, efficacious therapeutic agent can be identified during this global COVID-19 outbreak.