![]() The main thing TICO is testing is if the nMAb(s) result in more people with ‘sustained’ recovery i.e. There are in-between visits (Days 14, 42, 60, 75) to check on how people are doing, and conducted by phone once discharged from hospital. They will be seen in-person on the day of the nMAb infusion(Day 0), and then on Days 1,3,5,7,28 and 90 to assess health status, take bloods for safety and/or future COVID-19 research. Participants will be in TICO for 90 days. To test whether each nMAb is safe and beneficial, approx.1000 participants will need to be enrolled.Ĭonsenting participants are randomised to receive the nMAb(s) infusion or matched salt solution placebo everyone gets the COVID-19 standard-of-care treatment as well. If all goes well, the second stage will enrol approx.700 more. It is done in two stages, the first enrolling approx.300 participants, focussed on safety. It is a ‘master’ protocol, and allows new drugs to be tested very efficiently. TICO will evaluate whether an infusion of nMAb(s) plus COVID-19 standard-of-care treatment is safe and effective. TICO is an international, randomised double-blind trial in adults hospitalised with COVID-19. By giving an infusion of these nMAb(s) in addition to COVID-19 standard-of-care treatment, we hope hospitalised patients will recover more quickly. These synthetic neutralising monoclonal antibodies (nMAb) ‘neutralise’ the virus by binding to it and prevent it from entering cells in the body, including the lungs. The structure of the natural antibodies that hasten recovery from COVID-19 are now known this means synthetic forms have been manufactured. ![]() ![]() One antiviral treatment, remdesivir, and an anti-inflammatory drug, dexamethasone, have shown benefit these are now the COVID-19 standard-of-care treatment. Safe and effective treatments are urgently needed. SARS-CoV-2 is a novel coronavirus causing COVID-19 and has spread very rapidly.
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