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Passive Antibodies

EVUSHELD for COVID-19 (PACE-CLL Trial)

Phase 2

Waitlist Available

Research Sponsored by Sunnybrook Health Sciences Centre

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

PACE-CLL Trial Summary

This trial is to test a new drug, EVUSHELD, to see if it creates immunity to COVID-19 in people who didn't create immunity from the standard of care vaccination.

Eligible Conditions

COVID-19
Chronic Lymphocytic Leukemia
Coronavirus

PACE-CLL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Passive Immunity

Secondary outcome measures

Baseline T cell responses to COVID-19 as a potential predictor of breakthrough COVID-19 infections

COVID-19 Infection (RAT/PCR)

COVID-19 Infection (antibodies)

+5 more

Side effects data

From 2023 Phase 2 & 3 trial • 4044 Patients • NCT04518410

Blood glucose increased

Dyspnoea

Fatigue

Cough

Pyrexia

COVID-19 pneumonia

Alanine aminotransferase increased

Hypertension

Nasal obstruction

Chills

Headache

Hyperglycaemia

Diarrhoea

Nausea

Anaemia

Pain

Rhinorrhoea

Wheezing

Tinnitus

Diabetic ketoacidosis

Urosepsis

Hypersensitivity

Deep vein thrombosis

Aspartate aminotransferase increased

Blood creatinine increased

Blood glucose decreased

Hypoxia

Blood bilirubin increased

Ageusia

Rash

Flank pain

Acute kidney injury

Blood sodium decreased

Diabetes mellitus

Hyperkalaemia

Alopecia

Blood pressure systolic increased

Blood potassium increased

Muscular weakness

Sepsis

Respiratory distress

Upper gastrointestinal haemorrhage

Infusion related reaction

Haemoglobin decreased

Oropharyngeal pain

Anosmia

Blood creatinine decreased

Blood potassium decreased

COVID-19

Neutropenia

Vomiting

Hyperbilirubinaemia

Sinusitis

Blood alkaline phosphatase increased

Eye pain

Abdominal discomfort

100%

80%

60%

40%

20%

Study treatment Arm

SAB-185 (Low Dose) (Phase 3) Non-OMICRON Population

SAB-185 (Low Dose) (Phase 3) OMICRON Population

Casirivimab and Imdevimab (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)

PACE-CLL Trial Design

1Treatment groups

Experimental Treatment

Group I: EVUSHELDExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EVUSHELD

2023

N/A

~8240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,442 Total Patients Enrolled

12 Trials studying COVID-19

10,079 Patients Enrolled for COVID-19

AstraZenecaIndustry Sponsor

4,265 Previous Clinical Trials

288,605,282 Total Patients Enrolled

52 Trials studying COVID-19

256,197,523 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 is the FDA's current stance on EVUSHELD?

"EVUSHELD was given a 2 because, although Phase 2 trials offer some evidence of safety, there is no data at this time to support efficacy."

Answered by AI

Are there any available positions for volunteers in this research?

"Unfortunately, this particular clinical trial is not seeking patients at the moment. The information on clinicaltrials.gov shows that the study was last updated on October 12th, 2022 and originally posted October 1st, 2022. Although there are other 2704 studies currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Passive Antibodies Against COVID-19 With EVUSHELD in Vaccine Non-responsive CLL

2023. "Passive Antibodies Against COVID-19 With EVUSHELD in Vaccine Non-responsive CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465876.