TICO, NIH, 014 / ACTIV-3

Summary

TICO (Therapeutics for Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression. Trials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of this protocol. If an investigational agent shows superiority over placebo, SOC for the study of future investigational agents may be modified accordingly. The international trials within this protocol will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs. The protocol is for a randomized, blinded, controlled platform trial that allows investigational agents to be added and dropped during the course of the study for efficient testing of new agents against control (i.e., placebo + SOC) within the same trial infrastructure. When more than one agent is being tested concurrently, participants will be randomly allocated across agents (as well as between the agent and its placebo) so the same control group will be used, when feasible.


Inclusion Criteria

  • Signed informed consent.
  • Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
  • Symptoms of COVID-19 for ≤ 12 days.
  • Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

ACTIV-3: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19

Details
Disease Type/Condition

Other

Principal Investigator

Chen, Peter

Age Group

Adult

Phase

III

IRB Number

STUDY00000994

ClinicalTrials.gov ID

NCT04501978

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Chen, Peter

Age Group

Adult

Phase

III

IRB Number

014-ACTIV-3-TICO

ClinicalTrials.gov ID

NCT04501978

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?