Public Use Datasets

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

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

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

The study will evaluate the safety and efficacy of investigational agents aimed at improving outcomes of patients with acute respiratory failure related to COVID-19. Using a master protocol, successive trials within this 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 first investigational agents studied will be aviptadil (generic name for the synthetic version of Vasoactive Intestinal Peptide [VIP]) and remdesivir in a 2x2 factorial design for those eligible for both agents.  If eligible for only 1 agent, the randomization is 1:1 for active agent versus placebo. 
Protocol Summary

This COVID-19 treatment study is designed to evaluate the safety and efficacy of ensitrelvir, an anti-SARS-CoV-2 3C-like protease inhibitor developed by Shionogi & Co. Ltd, when given in addition to standard of care in patients hospitalized for medical management of COVID-19. The primary efficacy outcome will assess clinical recovery over 60 days. Participants will be randomized to receive a 5-day course of oral ensitrelvir or a 5-day course of matching oral placebo in addition to standard of care. The standard of care will be determined by local established guidelines and may include additional direct-acting antivirals (e.g., remdesivir) and immunomodulatory treatments. The planned sample size is 1500 participants.
Protocol Summary