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Antiviral

Abatacept for Coronavirus (ACTIV-1 IM Trial)

Phase 3
Waitlist Available
Led By Daniel K Benjamin, MD, PhD
Research Sponsored by Daniel Benjamin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 5, 8, 11, 15, and 29
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective. The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 5, 8, 11, 15, and 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3, 5, 8, 11, 15, and 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Had Recovered by Day 28
Secondary study objectives
Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO
Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen
Duration (Days) Alive and Free of Supplemental Oxygen
+20 more
Other study objectives
Number of patients with National Early Warning Scores (NEWS) <=2

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Standard of Care + infliximab or matching placeboActive Control2 Interventions
infliximab (single dose IV 5mg/kg given on day 1) or matching placebo
Group II: Standard of Care + abatacept or matching placeboActive Control2 Interventions
abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) or matching placebo
Group III: Standard of Care + cenicriviroc or matching placebo (closed to enrollment as of 3-Sep-2021)Active Control2 Interventions
cenicriviroc \[tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29\]. or matching placebo

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
30,153 Total Patients Enrolled
Daniel BenjaminLead Sponsor
4 Previous Clinical Trials
3,898 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
374 Previous Clinical Trials
407,311 Total Patients Enrolled
~388 spots leftby Nov 2025