Trial NCT04723394
Publication TACKLE - Montgomery H, Lancet Respir Med (2022) (published paper)
Dates: 2021-01-28 to 2021-07-22
Funding: Private (AstraZeneca)
Conflict of interest: Yes

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Argentina, Brazil, Czech Republic, Germany, Italy, Japan, Mexico, Poland, Spain, Russian Federation, UK, Ukraine, USA
Follow-up duration (days): 28
Inclusion criteria
  • Non-hospitalised adults
  • aged 18 years or older
  • documented laboratory-confirmed SARS-CoV-2 infection, as determined by RT-PCR (testing for viral RNA) or an antigen test (testing for presence of SARS-CoV-2 proteins) from any respiratory tract specimen collected 3 days or less before enrolment
  • WHO Clinical Progression Scale score of more than 1 to less than 4 (if hospitalized, for isolation/public health purposes only)
  • study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever
  • peripheral saturation of arterial blood with oxygen (oxygen saturation) of 92% or more obtained at rest by study staff within 24 h before enrolment
  • not involved in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalisation or 28 days after study entry, whichever was earliest.
Exclusion criteria
  • History of hospitalisation or currently hospitalised for COVID-19, or current need for hospitalisation or immediate medical attention in a clinic or emergency room service in the clinical opinion of the site investigator (some sites in Japan and Russia were required to hospitalise participants for isolation purposes upon testing positive for COVID-19)
  • history of hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a monoclonal antibody
  • previously received an investigational or licensed vaccine or other monoclonal antibody or biologic indicated for the prevention of SARS-CoV-2 or COVID-19 before study entry, or administration of these products was expected immediately after enrolment.
Interventions
Treatment
Tixagevimab+Cilgavimab
300 mg tixagevimab + 300 mg cilgavimab intramuscularly once-off
Control
Placebo

Participants
Randomized
participants :
Tixagevimab+Cilgavimab=456
Placebo=454
Characteristics of participants
N= 910
Mean age : NR
448 males
Severity : Mild: n= 910/ Asymptomatic: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
A composite of either severe COVID-19 or death from any cause through Day 29 ; AEs, SAEs, and AESIs through end of study. [ Time Frame: Through Day 457 ]
In the report
A composite of either severe COVID-19 or death from any cause through to day 29; adverse events, serious adverse events, and adverse events of special interest throughout the study.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The study did not achieve the target sample size specified in the trial registry. End of recruitment to the trial and therefore eventual sample size were event-driven, with completion specified when 43 primary outcome events had occurred. There is no change from the trial registration in the intervention and control treatments. The primary outcomes in the article reflect those in the registry. Some secondary outcomes in the registry are not reported. Follow up continues.