Summary Patient Information Sheet

D8851C00001

A Phase III Randomized, Double-blind, Placebo-Controlled, Multi-center Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-Hospitalized Adults (TACKLE)

 

Short title: AZD7442 for Treatment of COVID-19 in Outpatient Adults (TACKLE)

Thank you for showing an interest in this study. This summary sheet gives a brief overview of the study. The Main Patient Information Sheets provides more detail. You can ask us for more information at any point.

What will the study involve?

Screening visits to check you can take part - if eligible, you will be allocated, at random, to receive either the study treatment (called AZD7442) or a placebo injection. Placebo is a harmless injection of saline (salt and water). Half of the participants will receive placebo and half will receive the study treatment, therefore, you will have a 50% chance of receiving the study treatment.

  • You will receive your treatment once via 2 injections into your buttocks.

  • Attending treatment visits which include blood samples and ECGs to look at how safe and effective the treatment is.

  • Completing health questionnaires on a hand held electronic device (at home).

Condition Studied - Covid-19

Study Length - Up to 1 Year

Number of Visits - Up to 10 visits with most visits in the first 29 days

Could I be eligible to take part?

You Must:

  • Be at least 18 years old.

  • Have had a positive coronavirus test (we can provide this for you if necessary).

  • Must have had symptoms of coronavirus for less than 7 days with certain symptoms present in the last 24 hours.

You Must Not:

  • Be pregnant, breastfeeding, or trying to start a family or become pregnant for 1 year after receiving the study treatment.

  • Have had a coronavirus vaccine. (You may have a coronavirus vaccine after study day 30, if necessary). You will be give additional information about this if you decide to proceed with the study.

Why participate?

Information gained from this study may help treat people who have coronavirus to stop their condition worsening. You can decide to stop taking part at any time.

Are there risks?

There are always risks with taking part in any study. There are risks associated with the study medication and risks associated with the study procedures. These are described fully in the Main Patient Information Sheet.