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Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

Clinical Trial Details

SARS-CoV-2 is a new virus that has caused a widespread outbreak of an illness called COVID-19. In some people, it causes a mild to moderate symptoms, like a "cold." In others, this virus can cause a pneumonia (an inflammation of the lungs), which can be serious and life threatening. There is no proven treatment for COVID-19 for people who are not sick enough to be hospitalized. 

For each study drug that is tested in this study, there could be two study parts, or phases. In the first part, called Phase 2, we will see if the study drug is safe. We will also see if it can decrease how long people have COVID-19 symptoms and if it can help get rid of SARS-CoV-2 virus more than the placebo. Study drugs that appear to be safe and to work better than the placebo in the first part of the study will be tested in a separate second part of the study.

In the second part of the study, called Phase 3, we will continue to test how safe the study drug is. We will also continue to compare it to a placebo to see if it can reduce the number of people who have to go into the hospital or who die from COVID-19.  The study plans to replace the placebo comparison with a combination of monoclonal antibodies in future versions of the protocol. 

You will be told which phase of the study you are eligible for, as well as what study drugs are being evaluated in that phase. At each stage, new study drugs may be added (in other words, multiple study drugs may be studied at one time). The study is designed to rapidly evaluate new therapies for COVID-19. This could mean that the study finds that a study drug that you were started on will not be studied further. If this happens, we will tell you. If you agree we would like you to continue to participate in the study and have all of the study visits, but this is your choice. We will not ask you to stay on the study drug if early results suggest that the study drug is not safe.

Key Eligibility: 
  • people who have been diagnosed with SARS-CoV-2 and have symptoms of the disease it causes (COVID-19)
  • age 18 years or older

    Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jonathan Berardi, NP
212-746-4177
jlb4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2007022469

ClinicalTrials.gov:

NCT04518410

Sponsor:

ACTIV-2/A5401

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease