Therapeutics for Inpatients with COVID-19 (TICO) [COVID-19]
Research type
Research Study
Full title
A Multicentre, Adaptive, Randomised, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalised Patients with COVID-19 Short Title: Therapeutics for Inpatients with COVID-19 (TICO) INSIGHT Protocol Number: 014 / ACTIV-3
IRAS ID
287932
Contact name
Sarah Pett
Contact email
Sponsor organisation
Reagents of the University of Minnesota
Eudract number
2020-003278-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 8 days
Research summary
SARS-CoV-2 is a novel coronavirus causing COVID-19 and has spread very rapidly. Safe and effective treatments are urgently needed. One antiviral treatment, remdesivir, and an anti-inflammatory drug, dexamethasone, have shown benefit; these are now the COVID-19 standard-of-care treatment.
The structure of the natural antibodies that hasten recovery from COVID-19 are now known; this means synthetic forms have been manufactured. 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. 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.
TICO is an international, randomised double-blind trial in adults hospitalised with COVID-19. TICO will evaluate whether an infusion of nMAb(s) plus COVID-19 standard-of-care treatment is safe and effective. It is a ‘master’ protocol, and allows new drugs to be tested very efficiently. It is done in two stages, the first enrolling approx.300 participants, focussed on safety. If all goes well, the second stage will enrol approx.700 more. To test whether each nMAb is safe and beneficial, approx.1000 participants will need to be enrolled.
Consenting 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.
Participants will be in TICO for 90 days. 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. 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.
The main thing TICO is testing is if the nMAb(s) result in more people with ‘sustained’ recovery i.e. discharged from hospital, alive, and home for 14 consecutive days by Day 90.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0334
Date of REC Opinion
29 Sep 2020
REC opinion
Further Information Favourable Opinion