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Monoclonal Antibodies

AZD7442 for COVID-19

Phase 1
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 from screening (day -28 to -1) until follow-up visit (day 361)
Awards & highlights

Study Summary

This trial will determine if two different formulations of AZD7442 are equivalent in how they are metabolized by the body.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to -1) until follow-up visit (day 361)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to -1) until follow-up visit (day 361) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf)
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Maximum observed serum (peak) concentration (Cmax)
Secondary outcome measures
Apparent total body clearance after extravascular administration (CL/F)
Area under the serum concentration-time curve from time zero to 180 days post dose (AUC0-181d)
Serum
+8 more

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: AZD7442 (co-formulation)Experimental Treatment1 Intervention
Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.
Group II: AZD8895 and AZD1061 (clonal cell line material)Active Control2 Interventions
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
Group III: AZD8895 and AZD1061 (cell pool material)Active Control2 Interventions
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD7442
2020
Completed Phase 3
~6630

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,274 Previous Clinical Trials
288,613,197 Total Patients Enrolled
52 Trials studying COVID-19
256,197,298 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.

What are the goals that this clinical trial is aiming to achieve?

"According to the sponsor of this clinical trial, AstraZeneca, the primary outcome being measured is the Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast). This will be done over a period of 361 days, starting from Day 1. Additionally, this study will measure secondary outcomes including ADA responses to AZD7442 in serum following administration of AZD7442 , Time of last quantifiable serum concentration (tlast), and Area under the serum concentration-time curve from time zero to 60 days post dose (AUC0-61d) ."

Answered by AI

To whom is this research opportunity available?

"This clinical trial is admitting 225 patients with virus diseases between the ages of 18 and 130. Most notable, candidates must meet the following criteria: Healthy participants according to medical history, physical examination, and baseline safety laboratory tests., Documented negative results of a Severe Acute Respiratory Syndrome Corona Virus 2 reverse transcriptase polymerase chain reaction (SARS-CoV-2 RT-PCR) test collected ≤ 3 days prior to investigational medicinal drug (IMP) dose administration (Day 1) or a negative rapid SARS-CoV-2 antigen test on Day 1 (pre-dose)., Able to"

Answered by AI

Does a body of research exist for AZD7442?

"At the moment, there are five ongoing clinical trials for AZD7442. Of these, four are in Phase 3. Most of the research on AZD7442 is taking place in Chula Vista, California; however, there are 599 other locations conducting studies relating to this medication."

Answered by AI

Are there any vacancies in this research project for participants?

"This study is not admitting patients at the moment. The trial was first posted on 30th November 2021 and updated last on 12th August 2022. There are other ongoing trials, however, including 122 for virus diseases and 5 for AZD7442."

Answered by AI

What is the regulatory status of AZD7442?

"While Phase 1 trials are limited in the amount of safety data they provide, AZD7442 still received a score of 1."

Answered by AI

How many people are currently allowed to participate in this clinical trial?

"This specific clinical trial is not seeking new patients at this time, as the last update was on 8/12/2022. However, there are 122 other virus disease trials and 5 AZD7442 studies that are still looking for participants."

Answered by AI

Does this research include people who are middle-aged or older?

"As clearly laid out in the inclusion criteria, potential participants for this study must be between 18-130 years old."

Answered by AI

Is this clinical trial being run in a lot of different places across Canada?

"There are 10 clinical trial sites for this medication, which are situated in Cullman, Scottsdale, Orlando and other locations. To reduce strain on patients, it is best to select the location nearest you."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants
2021. "Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166421.
~66 spots leftby May 2025
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