COVID-19Phase 2NCT04583969
ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19
A Phase 2 study testing Lenzilumab and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 55 sites in 2 countries.
Trial summary
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Lenzilumab and Remdesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 527 participants
- Where
- 55 sitesin 2 countries
- Study dates
- 23 Oct 2020to 22 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult >/= 18 years of age at time of enrollment.
- Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g., Nucleic Acid Amplification Test [NAAT], antigen test) in any respiratory specimen, or saliva </=14 days prior to randomization.
- Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) (ordinal score 5, 6, or 7).
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- Women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception* from the time of screening through 5 months post study intraperitoneal (IP) dosing.
- Acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization.
- Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day 29.
Who cannot join
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal.
- Subjects with a low glomerular filtration rate (eGFR), specifically:
- Subjects with a glomerular filtration rate (eGFR) 20-30 mL/min are excluded unless in the opinion of the principal investigator (PI), the potential benefit of participation outweighs the potential risk of study participation.
- All subjects with a glomerular filtration rate (eGFR) <20 mL/min (including hemodialysis and hemofiltration) are excluded.
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of enrollment.
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- Allergy to any study medication.
- Received five or more doses of remdesivir prior to screening.
- Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK) inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the 4 weeks prior to screening.
- Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF) inhibitors, anti-IL-1 [e.g., anakinra, canakinumab], anti-IL-6 [e.g., tocilizumab, sarilumab, sitlukimab]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
- Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
- Received granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g., sargramostim) within 2 months prior to screening.
- Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with lenzilumab is larger than the risk of Coronavirus Disease 2019 (COVID-19).
- Received any live vaccine in the 4 weeks prior to screening.
- Known active tuberculosis.
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated hepatitis C (HCV) infection.
- History of pulmonary alveolar proteinosis (PAP).
- Has a malignancy currently receiving immunosuppressive chemotherapy, immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis.
- Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalizability of trial results.
- Positive test for influenza virus during the current illness (influenza testing is not required by protocol).
- Previous participation in an ACTIV-5/Big Effect Trial (BET).
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States53 sites
Hendrick Health - Hendrick Medical Center
Abilene, Texas, 79601
Grady Memorial Hospital
Atlanta, Georgia, 30303
Kern Medical Center
Bakersfield, California, 93306-4018
Baptist Hospitals of Southeast Texas Site
Beaumont, Texas, 77701
St. Charles Health System - St. Charles Bend Hospital
Bend, Oregon, 97701
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, 35233
Brigham and Women's Hospital - Infectious Diseases
Boston, Massachusetts, 02115-6110
Boston Medical Center - Center for Infectious Diseases - Shapiro Center
Boston, Massachusetts, 02118
The State University of New York - University at Buffalo - Department of Medicine
Buffalo, New York, 14203
Atrium Health ID Consultants & Infusion Care Specialists
Charlotte, North Carolina, 28209
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Penrose Hospital - Emergency Medicine
Colorado Springs, Colorado, 80907
St. Francis Medical Center
Colorado Springs, Colorado, 80923
Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Nuvance Health Danbury Hospital - Infectious Disease
Danbury, Connecticut, 06810
The Hope Clinic of Emory University
Decatur, Georgia, 30030-1705
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Englewood Hospital
Englewood, New Jersey, 07631
UCSF Fresno Center for Medical Education and Research - Clinical Research Center
Fresno, California, 93721
University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine
Gainesville, Florida, 32610
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases
Hershey, Pennsylvania, 17033
Methodist Hospital - Houston
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
St. Anthony Hospital
Lakewood, Colorado, 80228-1704
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205-7101
University of Southern California - Infectious Diseases
Los Angeles, California, 90089-0121
Norton Healthcare
Louisville, Kentucky, 40202
University of Louisville - Division of Infectious Diseases
Louisville, Kentucky, 40202
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
West Virginia University - Infectious Diseases Clinic
Morgantown, West Virginia, 26506
Yale School of Medicine - The Anlyan Center for Medical Research & Education - Immunobiology
New Haven, Connecticut, 06519-1612
Mount Sinai School of Medicine - Medicine - Infectious Diseases
New York, New York, 10029-6504
Hoag Hospital Newport Beach
Newport Beach, California, 92663
Nuvance Health - Norwalk Hospital - Asthma Pulmonary and Critical Care Medicine
Norwalk, Connecticut, 06856
University of Nebraska Medical Center - Infectious Diseases
Omaha, Nebraska, 68105
Nuvance Health - Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Monument Health - Clinical Research
Rapid City, South Dakota, 57701
Mayo Clinic, Rochester - Infectious Diseases
Rochester, Minnesota, 55905-0001
William Beaumont Hospital - Royal Oak Campus - Infectious Disease
Royal Oak, Michigan, 48073-6700
University of Utah - Infectious Diseases
Salt Lake City, Utah, 84132
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
Stanford, California, 94305-2200
Stony Brook Medicine - Stony Brook University Hospital
Stony Brook, New York, 11794
Jacobi Medical Center
The Bronx, New York, 10461-1119
Montefiore Medical Center - Infectious Diseases
The Bronx, New York, 10467-2401
University of Toledo Medical Center - Ruppert Clinic
Toledo, Ohio, 43614
The University of Arizona - Banner University Medical Center Tucson Campus - Tucson
Tucson, Arizona, 85724-0001
Carle Foundation Hospital
Urbana, Illinois, 61801
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
St. Anthony Hospital North Health Campus
Westminster, Colorado, 80023
Northwestern Medicine - Central DuPage Hospital - Infectious Disease
Winfield, Illinois, 60190
Wake Forest Baptist Health - Infectious Diseases
Winston-Salem, North Carolina, 27157
South Korea2 sites
Seoul National University Bundang Hospital - Division of Infectious Diseases
Bundang-gu Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.
Read more
One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
Read the detailed description
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.
One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of samples and may be conducted by phone. All subjects will undergo a series of efficacy and safety laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. OP swabs (oropharyngeal swabs are preferred, but if these are not obtainable, saliva or nasopharyngeal or nasal swabs may be substituted) and blood research samples plus safety laboratory tests will be collected on Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if infection control considerations or other restrictions prevent the subject from returning to the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be obtained.
The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8. The key secondary objectives are to 1) evaluate the clinical efficacy of different investigational therapeutics as assessed by time to recovery compared to the control arm, and 2) to evaluate the proportion of subjects alive and without respiratory failure through Day 29.
Contacts:
20-0013 Central Contact
Telephone: 1 (301) 7617948
Email: DMIDClinicalTrials@niaid.nih.gov
- Conditions
- COVID-19
- Being tested
- Lenzilumab, Placebo, Remdesivir
- Keywords
- Adults, COVID-19, Multicenter, Putative, Therapeutics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenzilumabBiological
Lenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity.
PlaceboOther
Placebo for lenzilumab is commercially sourced 0.9% sodium chloride.
RemdesivirDrug
Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524.
| Study group | Role | What they receive |
|---|---|---|
| Remdesivir + Lenzilumab | Experimental | 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. Receives: Biological: Lenzilumab; Drug: Remdesivir |
| Remdesivir + Placebo | Active comparator | 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. Receives: Other: Placebo; Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.
Measured: Day 1 through Day 29
Secondary outcomes (40)
Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score
Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.
Measured: Day 1 through Day 29
Time to Sustained Recovery in Participants With a Baseline Ordinal Score of 5 or 6, CRP<150mg/L and Age <85 Years
Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the clinical status ordinal scale (and does not return to a score of = 4 up to and including Study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, Continuous Positive Airway Pressure (CPAP), or Bilevel Positive Airway Pressure (BiPAP); 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.
Measured: Day 1 through Day 60
Time to Sustained Recovery in Participants With Any Baseline Ordinal Score
Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the clinical status ordinal scale (and does not return to a score of = 4 up to and including Study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.
Measured: Day 1 through Day 60
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death
Measured: Day 8
Change From Baseline in C-Reactive Protein (CRP)
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in D-dimer
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Ferritin
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Fibrinogen
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Alanine Aminotransferase (ALT)
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Aspartate Transaminase (AST)
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Creatinine
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in International Normalized Ratio (INR)
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Hemoglobin
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Platelets Count
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Total Bilirubin
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in White Blood Cell (WBC) Count
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Neutrophils
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Eosinophils
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Basophils
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Lymphocytes
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Monocytes
Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.
Measured: Days 1, 3, 5, 8, 11, 15, 29
Number of Participants Reporting Grade 3, 4, or 5 Clinical and/or Laboratory Adverse Events (AEs)
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events.
Measured: Day 1 through Day 60
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is defined as an AE or suspected adverse reaction that is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measured: Day 1 through Day 60
Number of Participants Who Discontinued or Temporarily Suspended Study Treatment
Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration.
Measured: Day 1 through Day 29
Duration of Hospitalization
Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason.
Measured: Day 1 through Day 29
Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use
Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died.
Measured: Day 1 through Day 29
Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use
Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died.
Measured: Day 1 through Day 29
Days of Non-invasive Ventilation/High Flow Oxygen Use
Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Measured: Day 1 through Day 29
Days of New Non-invasive Ventilation/High Flow Oxygen Use
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Measured: Day 1 through Day 29
Days of Supplemental Oxygen Use
Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.
Measured: Day 1 through Day 29
Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use
New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study.
Measured: Day 1 through Day 29
Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use
New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.
Measured: Day 1 through Day 29
Mean Change in Ordinal Scale
The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.
Measured: Days 1, 3, 5, 8, 11, 15, 22, 29
14-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
Measured: Day 1 through Day 15
28-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Measured: Day 1 through Day 29
59-day Participant Mortality
The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates.
Measured: Day 1 through Day 60
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29
Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit.
Measured: Day 29
Time to an Improvement of One Category From Baseline Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measured: Day 1 through Day 60
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measured: Day 1 through Day 60
Time to Death
The time to death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start23 Oct 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583969
- Sponsor's protocol ID
- 20-0013B
- Status last verified
- Jan 2022
- First submitted
- 9 Oct 2020
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
- ClinicalTrials.gov ID
- NCT04583969
- Acronym / sponsor ID
- 20-0013B
- Conditions
- COVID-19
- Keywords
- Adults, COVID-19, Multicenter, Putative, Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.
One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
Detailed description
This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.
One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of samples and may be conducted by phone. All subjects will undergo a series of efficacy and safety laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. OP swabs (oropharyngeal swabs are preferred, but if these are not obtainable, saliva or nasopharyngeal or nasal swabs may be substituted) and blood research samples plus safety laboratory tests will be collected on Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if infection control considerations or other restrictions prevent the subject from returning to the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be obtained.
The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8. The key secondary objectives are to 1) evaluate the clinical efficacy of different investigational therapeutics as assessed by time to recovery compared to the control arm, and 2) to evaluate the proportion of subjects alive and without respiratory failure through Day 29.
Contacts:
20-0013 Central Contact
Telephone: 1 (301) 7617948
Email: DMIDClinicalTrials@niaid.nih.gov
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remdesivir + Lenzilumab | Experimental | Biological: Lenzilumab, Drug: Remdesivir200-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. |
| Remdesivir + Placebo | Active comparator | Other: Placebo, Drug: Remdesivir200-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult >/= 18 years of age at time of enrollment.
- Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g., Nucleic Acid Amplification Test [NAAT], antigen test) in any respiratory specimen, or saliva </=14 days prior to randomization.
Key exclusion criteria (21 listed)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal.
- Subjects with a low glomerular filtration rate (eGFR), specifically:
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of enrollment.
- Allergy to any study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenzilumabLenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity. | Biological | Remdesivir + Lenzilumab |
| PlaceboPlacebo for lenzilumab is commercially sourced 0.9% sodium chloride. | Other | Remdesivir + Placebo |
| RemdesivirRemdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. | Drug | Remdesivir + Lenzilumab, Remdesivir + Placebo |
Primary outcome
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
Time frame: Day 1 through Day 29
Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.
40 secondary outcomes
Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score
Time frame: Day 1 through Day 29
Time to Sustained Recovery in Participants With a Baseline Ordinal Score of 5 or 6, CRP<150mg/L and Age <85 Years
Time frame: Day 1 through Day 60
Time to Sustained Recovery in Participants With Any Baseline Ordinal Score
Time frame: Day 1 through Day 60
Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8
Time frame: Day 8
Change From Baseline in C-Reactive Protein (CRP)
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in D-dimer
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Ferritin
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Fibrinogen
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Aspartate Transaminase (AST)
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Creatinine
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in International Normalized Ratio (INR)
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Hemoglobin
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Platelets Count
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Total Bilirubin
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in White Blood Cell (WBC) Count
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Neutrophils
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Eosinophils
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Basophils
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Lymphocytes
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Change From Baseline in Monocytes
Time frame: Days 1, 3, 5, 8, 11, 15, 29
Number of Participants Reporting Grade 3, 4, or 5 Clinical and/or Laboratory Adverse Events (AEs)
Time frame: Day 1 through Day 60
Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 60
Number of Participants Who Discontinued or Temporarily Suspended Study Treatment
Time frame: Day 1 through Day 29
Duration of Hospitalization
Time frame: Day 1 through Day 29
Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use
Time frame: Day 1 through Day 29
Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use
Time frame: Day 1 through Day 29
Days of Non-invasive Ventilation/High Flow Oxygen Use
Time frame: Day 1 through Day 29
Days of New Non-invasive Ventilation/High Flow Oxygen Use
Time frame: Day 1 through Day 29
Days of Supplemental Oxygen Use
Time frame: Day 1 through Day 29
Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use
Time frame: Day 1 through Day 29
Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use
Time frame: Day 1 through Day 29
Mean Change in Ordinal Scale
Time frame: Days 1, 3, 5, 8, 11, 15, 22, 29
14-day Participant Mortality
Time frame: Day 1 through Day 15
28-day Participant Mortality
Time frame: Day 1 through Day 29
59-day Participant Mortality
Time frame: Day 1 through Day 60
Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29
Time frame: Day 29
Time to an Improvement of One Category From Baseline Using an Ordinal Scale
Time frame: Day 1 through Day 60
Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale
Time frame: Day 1 through Day 60
Time to Death
Time frame: Day 1 through Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenzilumab and Remdesivir in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 55 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1 through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04583969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.