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Monoclonal Antibodies

AZD7442 for COVID-19 (TACKLE Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and day 169
Awards & highlights

TACKLE Trial Summary

This trial will test if a new antibody combination can safely treat adults with COVID-19 and prevent severe disease or death.

Eligible Conditions
  • COVID-19
  • Coronavirus

TACKLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and day 169
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29
Secondary outcome measures
A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169

Side effects data

From 2022 Phase 3 trial • 1131 Patients • NCT04625972
16%
Covid-19
11%
Cough
11%
Headache
8%
Fatigue
8%
Oropharyngeal pain
8%
Rhinorrhoea
7%
Nasal congestion
6%
Pyrexia
5%
Pain
4%
Chills
4%
Dyspnoea
3%
Diarrhoea
3%
Nausea
3%
Urinary tract infection
3%
Myalgia
2%
Sinus congestion
2%
Nasopharyngitis
2%
Upper respiratory tract infection
2%
Ageusia
2%
Arthralgia
2%
Anosmia
2%
Blood creatine phosphokinase increased
1%
Bronchitis
1%
Sinusitis
1%
Otitis media
1%
Anaemia
1%
Dehydration
1%
Anxiety
1%
Fall
1%
Vaccination complication
1%
Aspartate aminotransferase increased
1%
Gamma-glutamyltransferase increased
1%
Blood glucose increased
1%
C-reactive protein increased
1%
Dizziness
1%
Toothache
1%
Hypertension
1%
Influenza like illness
1%
Vomiting
1%
Malaise
1%
Asymptomatic covid-19
1%
White blood cells urine positive
1%
Decreased appetite
1%
Type 2 diabetes mellitus
1%
Epistaxis
1%
Back pain
1%
Muscle spasms
1%
Proteinuria
1%
Pain in extremity
1%
Dyspepsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AZD7442

TACKLE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD7442Experimental Treatment1 Intervention
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442.
Group II: PlaceboPlacebo Group1 Intervention
Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7442
2020
Completed Phase 3
~6630

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,793 Total Patients Enrolled
52 Trials studying COVID-19
256,196,612 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
South Carolina
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Statistics in MedicineJournal
Comparative Analysis of Two Rates
Miettinen, Olli, and Markku Nurminen. 1985. “Comparative Analysis of Two Rates”. Statistics in Medicine. Wiley. doi:10.1002/sim.4780040211.
The Lancet Infectious DiseasesJournal
A Minimal Common Outcome Measure Set for COVID-19 Clinical Research
Marshall, John C, Srinivas Murthy, Janet Diaz, N K Adhikari, Derek C Angus, Yaseen M Arabi, Kenneth Baillie, et al.. 2020. “A Minimal Common Outcome Measure Set for COVID-19 Clinical Research”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(20)30483-7.
American Journal of EpidemiologyJournal
A Modified Poisson Regression Approach to Prospective Studies with Binary Data
Zou, G.. 2004. “A Modified Poisson Regression Approach to Prospective Studies with Binary Data”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/aje/kwh090.
BiometricsJournal
Testing a Primary and a Secondary Endpoint in a Group Sequential Design
Tamhane, Ajit C., Cyrus R. Mehta, and Lingyun Liu. 2010. “Testing a Primary and a Secondary Endpoint in a Group Sequential Design”. Biometrics. Wiley. doi:10.1111/j.1541-0420.2010.01402.x.
~218 spots leftby Apr 2025
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