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Monoclonal Antibodies
Evusheld (AZD7442) for COVID-19
Phase 3
Waitlist Available
Led By Ralph Boccia, MD
Research Sponsored by MediMergent, LLC
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 12 months
Awards & highlights
Study Summary
This trial is designed to see if a single dose of Evusheld (AZD7442) can protect cancer patients who have recently been treated with immunotherapy from contracting a severe case of SARS-CoV-2, the virus that causes COVID-19.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AZD7442 Serum Concentration
Secondary outcome measures
Cancer Group and Treatment Group Comparison
SARS-CoV-2 Infection
Side effects data
From 2023 Phase 2 & 3 trial • 4044 Patients • NCT0451841010%
Blood glucose increased
6%
Blood creatinine increased
4%
Fatigue
3%
Cough
3%
Pyrexia
2%
Alanine aminotransferase increased
2%
Dyspnoea
2%
Chills
2%
Nausea
2%
Diarrhoea
2%
Arthralgia
2%
Headache
2%
COVID-19 pneumonia
2%
Pain
2%
Hypertension
2%
Rhinorrhoea
2%
Nasal obstruction
2%
Hyperglycaemia
1%
C-reactive protein increased
1%
Aspartate aminotransferase increased
1%
Blood albumin decreased
1%
Insomnia
1%
Haematocrit decreased
1%
Protein total decreased
1%
Acute kidney injury
1%
Fibrin D dimer increased
1%
Alopecia
1%
Blood urea increased
1%
Blood potassium increased
1%
Blood calcium decreased
1%
Dehydration
1%
Haemoglobin decreased
1%
Red blood cell sedimentation rate increased
1%
Oropharyngeal pain
1%
Serum ferritin increased
1%
Blood sodium decreased
1%
Dizziness
1%
White blood cell count increased
1%
Lymphocyte count decreased
1%
White blood cell count decreased
1%
Acute myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Casirivimab and Imdevimab (Phase 3) OMICRON Population
SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population
SAB-185 (Low Dose) (Phase 3) OMICRON Population
Bamlanivimab 700mg (Phase 2)
SAB-185 (Low Dose) Pooled Placebo (Phase 2)
Bamlanivimab 7000 mg (Phase 2)
AZD7442 (IV) (Phase 2)
Bamlanivimab 700mg (Phase 3)
BRII-196+BRII-198 (Pooled Phase 2/3)
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
AZD7442 (IV) Pooled Placebo (Phase 2)
Camostat (Phase 2)
Camostat Pooled Placebo (Phase 2)
AZD7442 (IM) (Phase 2)
SAB-185 (High Dose) (Phase 2)
AZD7442 (IM) Pooled Placebo (Phase 2)
SNG001 (Phase 2)
Bamlanivimab 7000mg Placebo (Phase 2)
Bamlanivimab 700mg Placebo (Phase 2)
SNG001 Pooled Placebo (Phase 2)
SAB-185 (Low Dose) (Phase 2)
Casirivimab and Imdevimab (Phase 3) Non-OMICRON Population
SAB-185 (High Dose) Pooled Placebo (Phase 2)
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
BMS 986414+BMS 986413 (Phase 2)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Evusheld (AZD7442)Experimental Treatment1 Intervention
Evusheld (tixagevimab+cilgavimab) 600 mg IM or IV administered one time only
Find a Location
Who is running the clinical trial?
MediMergent, LLCLead Sponsor
Ralph Boccia, MDPrincipal InvestigatorCenter for Cancer and Blood Disorders
3 Previous Clinical Trials
271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing to receive treatment with AZD7442 at a dose of 600 mg given either as an injection into the muscle or through a vein.You are only being treated for early-stage breast cancer with hormone therapy.Your doctor believes that you have less than a year to live because of your cancer.You are currently only receiving radiation therapy.You currently have a contagious respiratory infection.You don't want to receive treatment with the medication called AZD7442 through injection or intravenous (IV) infusion.You have had a bad allergic reaction in the past to any parts of AZD7442.If you have a blood cancer, you can still participate if it has been less than a year since your treatment and your condition is stable, improving, or getting worse as determined by the doctor.You can receive radiation therapy as long as it is not the only treatment you are receiving.You have had a fever above 100.0°F and/or experienced symptoms like coughing, chills, loss of smell or taste, or difficulty breathing within 5 days before joining the study.You have recently received or are planning to receive treatments for COVID-19, including convalescent plasma or other approved medications for the virus.
Research Study Groups:
This trial has the following groups:- Group 1: Evusheld (AZD7442)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this treatment come with any short-term or long-term risks?
"The safety of this medical intervention falls on a scale from 1 to 3. Our team at Power have given it a 3, as Phase 3 trials have both evidence of efficacy and multiple rounds data confirming safety."
Answered by AI
If I am below the age of 70, can I still participate in this research?
"In order for somebody to be eligible for this particular study, they must fall between the ages of 18 and 100. Out of the 2000 total trials, 345 are specifically for people under 18 while 1549 are geared towards older individuals aged 65 or more."
Answered by AI
Which types of patients would be the most appropriate for this research?
"This clinical trial is enrolling 1500 covid-19 patients aged 18 and up. Patients should meet the following criteria: have access to a "smartphone" or tablet or laptop or desktop computer and/or an email address, have a documented diagnosis of either hematologic malignancy or solid tumor as identified by standard ICD-10 diagnostic category, be on active treatment for solid tumor or hematologic malignancies including high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), as well as any FDA-approved alkyl"
Answered by AI
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