The ACTIV-2 Study

A5401 Adaptive Platform Treatment Trial for Outpatients with COVID-19 

If you wish to speak with one of our staff about our study, please leave us a message, and we'll get back to you ASAP.

Si desea hablar con un miembro de nuestro personal sobre nuestro estudio, por favor déjenos un mensaje y le responderemos lo antes posible.

The ACTIV-2 Study is testing different medicines to see if they are safe and can help adults with COVID-19. Finding treatments for COVID-19 is important because the virus is spreading quickly all over the world and can cause serious sickness and even death.

El estudio ACTIV-2 está probando diferentes medicamentos para ver si son seguros y pueden ayudar a los adultos con COVID-19. Encontrar tratamientos para COVID-19 es importante porque el virus se está propagando rápidamente por todo el mundo y puede causar enfermedades graves e incluso la muerte.

Main Purpose of this Investigational Study:

This study will evaluate the ability of various study medications to improve the symptoms of COVID-19.

 

Main Requirements to Enter This Study:

  • 18 years of age or older

  • Tested positive for COVID-19 (not more than 7 days ago)

  • Experiencing at least one of the following symptoms: fever, sore throat, chills, cough, shortness of breath, tiredness, headache, stuffy or runny nose, body pain or muscle aches, nausea or throwing up, diarrhea

  • Are at home (not in the hospital)

  • Agreement to not participate in another COVID-19 study during the study period

 

Length of Study: 

24 weeks

28 days of intensive follow-up, followed by limited 

follow-up through 24 weeks (about 6 months).

Overview of Study:

Participants will be randomized to take an active drug or a placebo. A placebo looks like a "real" drug, but it does not have any active medication in it. 

Different drugs will be used as part of the study at different times. We will give you information about the drugs being tested when you contact us.

ACTIV-2 aims to develop a treatment that can prevent people with COVID-19 from developing advanced disease that requires hospitalization.

ACTIV-2 will evaluate the safety and efficacy of investigational agents to treat adults who have COVID-19 illness but do not require hospitalization. The study will also enable researchers to assess the correlation between changes in viral shedding and clinical outcomes, leading to a better understanding of whether effective medications can reduce or halt the transmission of SARS-CoV-2 (the virus that causes COVID-19) to others.

 

ACTIV-2 is a randomized, blinded, controlled adaptive platform that allows promising investigational agents to be added and removed over the course of the study, in order to efficiently test a variety of new agents against placebo within the same trial infrastructure.

In phase 2 of ACTIV-2, investigational agents will be studied to determine their safety, antiviral activity, and ability to reduce the duration of COVID-19 symptoms over 28 days.

 

These agents will be selected based on the presence of in vitro data demonstrating activity against SARS-CoV-2 and phase 1 pharmacokinetics and safety data.

 

In phase 2, 110 participants will receive the investigational agent and be compared to 110 participants randomized to receive placebo. If an agent demonstrates positive results and meets study-defined criteria for further evaluation, it will advance from phase 2 to phase 3.

 

The phase 3 studies will evaluate the ability of each investigational agent to prevent hospitalization and death in non-hospitalized adults with COVID-19; 1,000 participants will receive the investigational agent (inclusive of the 110 participants from phase 2) and be compared to 1,000 participants randomized to placebo.

Study Medication:

The first investigational agent to be evaluated by ACTIV-2 is LY-CoV555, an experimental monoclonal antibody treatment made by Lilly Research Laboratories in partnership with AbCellera Biologics.

 

AbCellera and the Vaccine Research Center at NIAID identified the antibody from a blood sample of one of the first people in the United States to recover from COVID-19.

 

Study Procedures:

Providing blood samples and self-collected nasal swabs, giving your medical history, completing a study diary to record your symptoms and temperature. Some participants may be asked to give deep nasal swabs and saliva.

 

Reimbursement:  

$300-500 if all procedures are completed.

 

Contact:

Contact ACTU Staff at 206-773-7129 (text or call) or use the appointment button below.

Harborview Medical Center

325 9th Avenue

2nd Floor West Clinic

Seattle, WA 98104

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