Public use datasets are available for the 8 clinical trials:
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
Vaccination for Recovered Inpatients with COVID-19 (VATICO)
This study was intended to evaluate the differences in antibody response
to SARS-CoV-2 vaccines based on vaccination timing and the number of doses
given, among participants in the TICO trial who recovered from COVID-19
infection within 28 to 90 days after enrolling in TICO. Study participants
were randomized to one of 4 vaccination groups: I1, one dose at VATICO
enrollment; I2, one dose immediately and a second dose 4 weeks later; D1,
one dose deferred until 12 weeks after VATICO enrollment; D2 one dose 12
weeks after VATICO enrollment followed by a second dose 4 weeks later. The
planned sample size was 640 participants.
Protocol Summary
Major Results Publications for TICO, ITAC, VATICO Trials