NCT04546581

Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 593 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.

Detailed description

The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient's clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. The ordinal endpoint is defined as follows: 7\. Death 6\. End-organ failure 5\. Life-threatening end-organ dysfunction 4\. Serious end-organ dysfunction 3\. Moderate end-organ dysfunction 2\. Limiting symptoms due to COVID-19 1\. No limiting symptoms due to COVID-19 Secondary endpoints include time to the 3 least favorable categories, time to the 2 most favorable categories, and the pulmonary only and thrombotic only components of the primary ordinal outcome. Mortality, adverse events (AEs), including infusion reactions, and biological correlates of therapeutic activity are also assessed. Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups (hIVIG + SOC versus placebo + SOC ) can be compared for multiple outcomes, and results can be compared or combined with other trials. Participants will be randomized (1:1) to a single infusion of hIVIG + SOC or placebo + SOC on the day of randomization (Day 0). Participants taking remdesivir prior to randomization may be enrolled if eligibility criteria are met. Randomized participants who were not taking remdesivir before randomization will start taking remdesivir immediately following the infusion of hIVIG or placebo unless remdesivir is contraindicated. Participants will be followed for 28 days and, if the trial goes to completion, the primary analysis will be completed after all participants are followed for 28 days.

Conditions

• COVID
• COVID-19
• SARS-CoV-2
• SARS (Severe Acute Respiratory Syndrome)

Interventions

Type	Name	Description
BIOLOGICAL	Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)	Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
OTHER	Placebo	Participants will receive a single infusion of the placebo (saline).
DRUG	Remdesivir	Remdesivir will be given to participants in both groups as standard of care (SOC).

Timeline

• Start date: 2020-10-08
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2020-09-14
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

39 sites across 7 countries: United States, Denmark, Greece, Japan, Nigeria, Spain, United Kingdom

Regulatory

• FDA-regulated drug study