Can we use existing medications to treat people with early diagnosed COVID-19?
The TOGETHER trial is the result of a partnership between health researchers in Brazil and Canada. As the result of the COVID-19 pandemic and the serious implications for people living in low and medium-income countries, a partnership was rapidly formed to find affordable and effective treatments from existing medications already used to treat other health conditions, with the aim of saving lives.
The TOGETHER Trial consists of 22 sites across Brazil, where patients are being treated with a range of potential new COVID-19 therapeutic agents. The aim is to give these potential therapies at the early stages of infection, in order to prevent more serious complications or death. All of these 22 trial sites share and compare their data to generate more statistically meaningful results. The trial has now expanded to South Africa led by Francois Venter, Pakistan led by Zulfiquar Bhutta, and Rwanda led by Sabin Nsanzimana.
Another exciting element of the TOGETHER Trial is our ability to scan the global research frontier and look for evidence emerging from similar studies. Our adaptive platform design allows us to incorporate relevant data from other research studies, along with our own results, to yield more meaningful findings overall.
Data emerging from our clinical trials is reviewed regularly, so that those treatments showing to be useful can be used to treat patients early on. This will give health professionals more options to support people with COVID-19 and improve health outcomes.
The development of effective vaccines against the COVID-19 virus holds tremendous potential to slow and eventually halt this pandemic altogether. Unfortunately, access to vaccines in low and middle-income countries is a challenge, and people are suffering as a consequence. This reality makes the need for effective treatments in the early stages of infection all the more important.
An international research collaboration.
The TOGETHER Trial represents a truly international collaboration in response to an unprecedented pandemic in modern times. As a multination institutional partnership, resources and expertise from all countries working in the TOGETHER network are being brought to bear in order to identify new potential uses of existing medications, which can be re-purposed to prevent COVID-19 related morbidity and mortality.
This international trial is financially supported by private sector philanthropic agencies, which have dedicated financial resources to the fight against COVID-19 in low and middle-income countries.
The TOGETHER Trial represents a truly international collaboration in response to an unprecedented pandemic in modern times
Innovative research methods for real-life challenges.
Clinical trials are rooted in rigorous research, which involve strict controls and repeated measurements. Not surprisingly, this takes time and money, and rightfully so, given the risks.
Typically, health research involves people being assigned to either experimental groups, where they receive the treatment under investigation, or control groups where they do not. By observing how hundreds, or even thousands of people respond to the experimental therapy, when compared to those who do not receive it, conclusions are drawn about safety and effectiveness.
The TOGETHER Trial is using a new type of research strategy, called adaptive platform trials. Adaptive platform trials are an effective research strategy when investigating multiple treatments for the same condition, such as COVID-19. Some of the features of adaptive platform trials that make it unique include:
- Reviewing data as it emerges from the study in real-time, rather than waiting until the end of the trial.
- Responding to emerging trial data sooner, which allows investigators to make the trial safer for participants.
- Adaptive platform trials are able to test multiple treatments against a condition at the same time, and using only one control group.
- Trials for specific treatments can be stopped sooner, if the data suggests that they are not working, or working very well. This saves both valuable time and money.
These efficiencies lead to the faster development and approval of new treatments, especially when every single day matters.
The TOGETHER Trials have received research ethics approval in both Brazil (CEP/CONEP#: 41174620.0.1001.5120) and in Canada (HiREB#: 13390). An independent data and safety monitoring committee is providing ongoing oversight of our work.
