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Lenzilumab for COVID-19
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to a hospital with symptoms suggestive of Coronavirus Disease 2019 (COVID-19) and requires ongoing medical care.
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, 5, 8, 11, 15, 22, 29
Awards & highlights
Study Summary
ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19
Eligible Conditions
- COVID-19
- Coronavirus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 3, 5, 8, 11, 15, 22, 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 5, 8, 11, 15, 22, 29
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Baseline Ordinal Score of 5 or 6, C-reactive Protein (CRP)<150mg/L and Age <85 Years
Secondary outcome measures
14-day Participant Mortality
28-day Participant Mortality
59-day Participant Mortality
+37 moreSide effects data
From 2022 Phase 2 trial • 527 Patients • NCT0458396910%
Respiratory failure
6%
Hypoxia
6%
Acute respiratory failure
4%
Hypertension
4%
Lymphocyte count decreased
3%
Pneumonia
3%
Pulmonary embolism
3%
Glomerular filtration rate decreased
2%
Pneumothorax
2%
Shock
2%
Pneumonia bacterial
2%
Sepsis
2%
Septic shock
2%
Acute kidney injury
2%
Respiratory distress
1%
Anaemia
1%
Gastrointestinal haemorrhage
1%
Streptococcal bacteraemia
1%
Transaminases increased
1%
Delirium
1%
Acute myocardial infarction
1%
COVID-19 pneumonia
1%
Alanine aminotransferase increased
1%
Acute respiratory distress syndrome
1%
Dyspnoea
1%
Pneumomediastinum
1%
Deep vein thrombosis
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Remdesivir + Lenzilumab
Remdesivir + Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Remdesivir + LenzilumabExperimental Treatment2 Interventions
200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses. N=275.
Group II: Remdesivir + PlaceboActive Control2 Interventions
200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses. N=275.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
2020
Completed Phase 3
~21440
Lenzilumab
2020
Completed Phase 3
~970
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,479 Total Patients Enrolled
78 Trials studying COVID-19
291,266 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.
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