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Monoclonal Antibodies

Ravulizumab for Coronavirus

Phase 3
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
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 120 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial will test whether a drug called ravulizumab can help treat people with COVID-19 who have kidney damage due to a condition called thrombotic microangiopathy.

Eligible Conditions
  • Coronavirus
  • Acute Kidney Failure
  • Thrombotic Microangiopathy
  • Acute Kidney Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the efficacy of ravulizumab to ameliorate SARS-CoV-2 (COVID-19)-induced acute kidney injury manifesting as thrombotic microangiopathy.
Secondary study objectives
Evaluation of pharmacokinetics of ravulizumab in participants with COVID-19

Side effects data

From 2022 Phase 4 trial • 18 Patients • NCT04320602
33%
Fatigue
17%
Abdominal pain
17%
SARS-CoV-2 test positive
17%
Cough
17%
COVID-19
11%
Back pain
11%
Nasopharyngitis
11%
Non-cardiac chest pain
11%
Dyspnoea
6%
Pain
6%
Chest discomfort
6%
Rash
6%
Retinal haemorrhage
6%
Body temperature abnormal
6%
Pain in extremity
6%
Herpes zoster
6%
Haemoglobinuria
6%
Nail ridging
6%
Arthralgia
6%
Peripheral swelling
6%
Influenza like illness
6%
Pneumonia
6%
Asthenia
6%
Headache
6%
Neurodermatitis
6%
Skin lesion
6%
Chromaturia
6%
Nephrolithiasis
6%
Pyrexia
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Constipation
6%
Extravascular haemolysis
6%
Haemoglobin decreased
6%
Upper respiratory tract congestion
6%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional armExperimental Treatment1 Intervention
ravulizumab
Group II: Control armActive Control1 Intervention
patients in this arm will recieve standard care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,203 Total Patients Enrolled

Media Library

Ravulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04570397 — Phase 3
Coronavirus Research Study Groups: Interventional arm, Control arm
Coronavirus Clinical Trial 2023: Ravulizumab Highlights & Side Effects. Trial Name: NCT04570397 — Phase 3
Ravulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570397 — Phase 3
~7 spots leftby Nov 2025
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