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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

Study 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 Injury
  • Thrombotic Microangiopathy

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

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

Side effects data

From 2022 Phase 3 trial • 195 Patients • NCT03056040
31%
Headache
30%
Nasopharyngitis
28%
Upper respiratory tract infection
21%
Fatigue
19%
Diarrhoea
19%
Pyrexia
18%
Nausea
17%
Cough
15%
Abdominal pain
14%
Back pain
14%
Dizziness
13%
Pain in extremity
11%
Arthralgia
11%
Influenza like illness
10%
Oropharyngeal pain
10%
Rhinitis
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Basal cell carcinoma
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab

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
1,608 Previous Clinical Trials
11,469,845 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

Frequently Asked Questions

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

Are there other instances where Ravulizumab has been used in research?

"There are currently 16 active clinical trials researching ravulizumab. Of these, 13 are in phase 3. Although the majority of these studies are based in Whittier, California, there are 839 clinical trial sites in total."

Answered by AI

Has the FDA cleared Ravulizumab for use?

"There is both clinical and anecdotal evidence to support the safety of Ravulizumab, leading our team to give it a score of 3."

Answered by AI

Have there been other similar studies conducted in the past?

"Alexion Pharmaceuticals first sponsored a trial for Ravulizumab in 2016, which involved 270 patients. After the successful completion of the Phase 3 drug trial, Ravulizumab received global approval and today there are 16 studies being conducted in 193 cities and 31 nations."

Answered by AI

Are there any medical conditions that would make a person ineligible for this trial?

"Eligible participants for this study must have contracted covid-19 and be between 18-85 years old. So far, this clinical trial has admitted ~30 patients."

Answered by AI

Can patients sign up for this testing program at this time?

"The information available on clinicaltrials.gov tells us that this study is still looking for patients to enroll. The trial was created on December 18th 2020 and was updated as recently as July 25th, 2022. Currently, the plan is to have 32 patients at 1 site."

Answered by AI

Does this experiment restrict participation to elderly individuals?

"The age limits for participation in this study are 18-85 years old."

Answered by AI

How is Ravulizumab most often employed?

"Ravulizumab is a common intervention for disease activity. However, it can also be used to manage a patient's hemolysis, thrombotic microangiopathies, atypical hemolytic uremic syndrome, and more."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ravulizumab and COVID-19
Andrew Michael Siedlecki 2020. "Ravulizumab and COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570397.
~7 spots leftby Apr 2025
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