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AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

CompletedPhase 3

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: COVID-19

Interventions: AZD7442, Placebo, Remdesivir

Countries: United States, Denmark, Greece, Poland, Singapore, Spain, Switzerland, Uganda

This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

• Refer to the master protocol (NCT04501978)

Exclusion Criteria:

* Refer to the master protocol (NCT04501978)
* Additional Exclusion Criteria:

  * Pregnant women
  * Nursing mothers
  * Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through the entire 18 months of the study
  * Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through the entire 18 months of the study.
* In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.

Locations (124)

Tucson, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Fresno, California, United States
La Mesa, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Mather, California, United States
Newport Beach, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Francisco, California, United States
Stanford, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
West Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Bay Pines, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
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