Public Use Datasets

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Public use datasets are available for the 7 clinical trials:

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A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigtational Therapeutics for Hospitalized Patients with COVID-19 (TICO)

The study will evaluate the safety and efficacy of multiple investigational agents intended to enhance the host immune response to SARS-CoV-2 infection, or directly enhance viral control, in order to limit disease progression. Using a master protocol, successive trials with the protocol will be adaptive, randomized, and initially placebo-controlled. All participants will receive standard of care (SOC) treatment. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. The initial investigational agents will be neutralizing monoclonal antibodies.
Protocol Summary

An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19 (ITAC)

This treatment study is intended to evaluate the safety and efficacy of hyperimmune intravenous immunoglobulin (hIVIG) administered to patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Treatment with hIVIG, derived from the plasma of individuals who recover and develop neutralizing antibodies, is a potentially useful therapeutic approach to COVID-19. Emerging data suggest that humoral immunity to SARS-CoV-2 may develop relatively late in the course of infection, and is variable between individuals with some showing limited antibody development. Augmenting host antibody response with hIVIG to SARS-CoV-2 at the onset of clinical progression, before end-organ failure has developed, may reduce the subsequent risk of further disease progression and death.  The planned study sample size is 500 participants.
Protocol Summary

Major Results Publications for TICO and ITAC Trials

A neutralizing monoclonal antibody for hospitalized patients with Covid-19. N Engl J Med 2021. ACTIV-3/TICO LY-CoV555 Study Group.
https://www.nejm.org/doi/10.1056/NEJMoa2033130

Responses to a neutralizing monoclonal antibody for hospitalized patients with COVID-19 according to baseline antibody and antigen levels. Ann Intern Med 2022. ACTIV-3/TICO Bamlanivimab Study Group
https://doi.org/10.7326/M21-3507

Efficacy and safety of two neutralizing monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalized with COVID-19 (TICO): a randomized controlled trial. ACTIV-3/TICO Study Group. Lancet Infect Dis 2021.
https://doi.org/10.1016/S1473-3099(21)00751-9

Tixagevimab-cilgavimab for treatment of patients hospitalized with COVID-19: a randomized, double-blind, phase 3 trial. Lancet Respir Med 2022. ACTIV-3/TICO Study Group.
https://doi.org/10.1016/S2213-2600(22)00215-6

Efficacy and safety of Ensovibep for adults hospitalized with COVID-19. Ann Intern Med 2022. ACTIV-3/TICO Study Group.
https://doi.org/10.7326/M22-1503

Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet 2022. The ITAC (INSIGHT 013) Study Group.
https://doi.org/10.1016/S0140-6736(22)00101-5