Newly Funded Study: Therapeutics for Inpatients with COVID-19 (TICO) study


Dr Eriobu Nnakelu is the Nigerian principal Investigator of the Therapeutics for Inpatients with COVID-19 study (TICO).  The  Therapeutics for Inpatients with COVID-19 (TICO) study is a multicenter, adaptive, randomized, blinded controlled trial of the safety and efficacy of investigational therapeutics for hospitalized patients with COVID-19. This study is evaluating the safety and efficacy of multiple investigational agents aimed at modifying human (COVID 19 infected) immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. Study participants will be randomized to either receive the active agent or placebo while all participants (active and control) will receive Remdesivir as Standard of Care (SOC).

Nigeria is currently testing the MP0420 (Ensovibep) which is a protein that is said to neutralize COVID-19 virus through a strong binding affinity. Other investigational products will be tested serially or synchronously during the 3 – 4 years course of the study.

TICO has 2 enrollment stratum for each test drug. Participants without organ failure will be recruited into the stratum 1; and if the investigational drug shows “promise” following a thorough Data and Safety Monitoring Board (DSMB) review, enrollment will be expanded into the stratum 2 to include participants with organ failure or severe clinical conditions.

The DSMB will regularly review interim analyses and summarize safety and efficacy outcomes. TICO study is funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs as well as multiple Pharma as part of the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) collaborative network of research for finding treatment for the COVID 19 pandemic.

TICO is currently being implemented in Nigeria at the University of Abuja Teaching Hospital Gwagwalada and supported by the Nigeria COVID-19 Research Consortium (NCRC).