AZD7442 for Treatment of COVID-19 in Outpatient Adults (TACKLE) [COVID-19]
Research type
Research Study
Full title
A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
IRAS ID
291930
Contact name
Richard Hobbs
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-005315-44
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 8 days
Research summary
A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe, with over 35 million confirmed cases reported and more than one million associated deaths according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare systems with significant socioeconomic impacts. Effective interventions to prevent or treat COVID-19 remain few in number and clinical experience is limited.
There is an urgent need to rapidly evaluate treatments in the non-hospitalised setting to prevent disease progression and reduce serious complications of COVID-19 and transmission. This Phase III study will assess whether AZD7442 can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death. All participants will receive background local standard of care therapy regardless of the study treatment group to which they are randomised.
Approximately 80 to 90 sites will participate in this study. Participants will be outpatient adults (≥18 years) with a documented positive SARS-CoV-2 molecular test from a sample collected ≤3 days prior to study entry and with ≤ 7 days of symptoms of COVID-19 at study entry, plus the presence of select symptoms within 24 hours prior to study entry.
Approximately 1700 participants will be randomised in a 1:1 ratio to receive a single intramuscular dose of AZD7442 or placebo. After administration of the dose of study intervention on Day 1, participants will undergo 28 days of intensive follow-up, followed by limited follow-up through 365 days.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/HRA/5769
Date of REC Opinion
6 Jan 2021
REC opinion
Further Information Favourable Opinion