Most clinical trials for COVID-19 are based in higher-income country acute care hospitals (COVID-19 Trial Tracker). Many of these trials exclude marginalized poverty stricken populations, such as people with severe malnutrition, people living with HIV (PLHIV) and people with active or latent tuberculosis (TB).
The goal of the TOGETHER trial is to determine the effectiveness and safety of the initial treatments of high-risk adults within 48 hours of being diagnosed with SARS-CoV-2 infection, who are not requiring hospitalization, Using repurposed, widely availiable, and economically feasible drugs. This trial uses a novel adaptive platform design.
This trial is based in Brazil and South Africa and will focus on four treatment arms against a placebo arm.
As the global COVID-19 pandemic continues, clinical trials demonstrate limited effective pharmaceutical interventions, and mass vaccination is a long way off for low and middle-income countries (LMICs). Hospitalizations are already overwhelming healthcare systems across the globe, the need for developing a treatment to reduce hospital admission in patients infected with SARS-CoV-2 is dire. The need for treatments in early disease is paramount. Evidence is quickly emerging that suggests a number of drugs may have a promising effect on reducing COVID-19 disease severity in patients with mild to moderate disease. The TOGETHER Trial hopes to help identify which repurposed therapies are most effective, in order to slow the pandemic while many countries await the delivery of vaccines.
Concurrent with all sites, we will work together to generate comparative data. Data from the trial will be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients and ineffective treatment can be ceased and resources re-allocated to more encouraging leads. The TOGETHER Trial team will constantly review information on new drugs and include promising ones in the trial.
Belo Horizonte, Brazil