MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT ID: NCT05780463
Last Updated: 2024-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
485 participants
INTERVENTIONAL
2021-06-11
2023-06-08
Brief Summary
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Detailed Description
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This is a randomized, blinded, controlled sub-study of MP0420 plus current SOC against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.
Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).
An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.
If MP0420 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.
This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MP0420 plus SOC
* MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
MP0420
MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.
Remdesivir
Antiviral agent
Placebo plus SOC
* Placebo administered by IV infusion
* Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo
Commercially available 0.9% sodium chloride solution
Remdesivir
Antiviral agent
Interventions
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MP0420
MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.
Placebo
Commercially available 0.9% sodium chloride solution
Remdesivir
Antiviral agent
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. Nursing mothers
3. Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 11 weeks after receiving MP0420/placebo
4. Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 11 weeks after receiving MP0420/placebo.
18 Years
ALL
No
Sponsors
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International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
NETWORK
University of Copenhagen
OTHER
Medical Research Council
OTHER_GOV
Kirby Institute
OTHER_GOV
Washington D.C. Veterans Affairs Medical Center
FED
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Heart, Lung, and Blood Institute (NHLBI)
NIH
US Department of Veterans Affairs
FED
Prevention and Early Treatment of Acute Lung Injury
OTHER
Cardiothoracic Surgical Trials Network
OTHER
Molecular Partners AG
INDUSTRY
University of Minnesota
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jens Lundgren, Prof.
Role: PRINCIPAL_INVESTIGATOR
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
James Neaton, Prof.
Role: STUDY_CHAIR
INSIGHT Statistical and Data Management Center, University of Minnesota
Locations
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Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
Tucson, Arizona, United States
Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.
Tucson, Arizona, United States
Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
Chula Vista, California, United States
Community Regional Medical Center (Site 203-005), 2823 Fresno Street
Fresno, California, United States
Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1
La Mesa, California, United States
VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)
Long Beach, California, United States
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
Los Angeles, California, United States
Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
Mather, California, United States
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
Newport Beach, California, United States
UC Davis Health (Site 203-004), 2315 Stockton Blvd.
Sacramento, California, United States
VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
San Diego, California, United States
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
San Francisco, California, United States
San Francisco VAMC (Site 074-002), 4150 Clement St.
San Francisco, California, United States
UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
San Francisco, California, United States
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
Stanford, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building
Torrance, California, United States
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
Aurora, Colorado, United States
Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
Denver, Colorado, United States
West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
West Haven, Connecticut, United States
MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW
Washington D.C., District of Columbia, United States
Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
Bay Pines, Florida, United States
Miami VAMC (Site 074-003), 1201 NW 16 Street
Miami, Florida, United States
Hillsborough County Health Department, University of South Florida (Site 032-001)
Tampa, Florida, United States
Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
Atlanta, Georgia, United States
Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
Fort Wayne, Indiana, United States
Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue
Topeka, Kansas, United States
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
New Orleans, Louisiana, United States
University of Maryland Medical Center (Site 301-019), 22 South Greene Street
Baltimore, Maryland, United States
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
Boston, Massachusetts, United States
Baystate Medical Center (Site 201-001), 759 Chestnut Street
Springfield, Massachusetts, United States
University of Michigan (Site 205-001), 1500 East Medical Center Drive
Ann Arbor, Michigan, United States
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100
Minneapolis, Minnesota, United States
Hennepin Healthcare (Site 027-001), 701 Park Avenue
Minneapolis, Minnesota, United States
Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.
Minneapolis, Minnesota, United States
University of Mississippi Medical Center (Site 202-005), 2500 North State Street
Jackson, Mississippi, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
Lebanon, New Hampshire, United States
Cooper University Hospital (Site 019-001), One Cooper Plaza
Camden, New Jersey, United States
SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.
Brooklyn, New York, United States
Maimonides Medical Center (Site 033-002), 4802 10th Avenue
Brooklyn, New York, United States
Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street
The Bronx, New York, United States
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
The Bronx, New York, United States
Duke University Hospital (Site 301-006), 2301 Erwin Road
Durham, North Carolina, United States
Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue
Cleveland, Ohio, United States
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
Portland, Oregon, United States
Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
Portland, Oregon, United States
Rhode Island Hospital (Site 080-036), 593 Eddy Street
Providence, Rhode Island, United States
The Miriam Hospital (Site 080-039), 164 Summit Ave.
Providence, Rhode Island, United States
Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
Charleston, South Carolina, United States
MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
Charleston, South Carolina, United States
MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
Florence, South Carolina, United States
VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South
Nashville, Tennessee, United States
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
Nashville, Tennessee, United States
Hendrick Medical Center (Site 080-014), 1900 Pine Street
Abilene, Texas, United States
CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
Corpus Christi, Texas, United States
Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
Dallas, Texas, United States
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
Dallas, Texas, United States
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
Dallas, Texas, United States
Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
Houston, Texas, United States
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
Houston, Texas, United States
CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.
Longview, Texas, United States
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
Murray, Utah, United States
University of Virginia Health Systems (Site 301-021), 1215 Lee Street
Charlottesville, Virginia, United States
Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue
Roanoke, Virginia, United States
Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
Salem, Virginia, United States
Swedish Hospital First Hill (Site 208-005), 747 Broadway
Seattle, Washington, United States
West Virginia University (Site 301-023), One Medical Center Drive
Morgantown, West Virginia, United States
Aalborg Hospital (Site 625-005), Hobrovej 18
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
Aarhus N, , Denmark
Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
Copenhagen, , Denmark
Righospitalet (Site 625-006), Blegdamsvej 9,
Copenhagen Ø, , Denmark
Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
Herlev, , Denmark
Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
Hillerød, , Denmark
Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
Hvidovre, , Denmark
Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
Kolding, , Denmark
Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
Odense, , Denmark
Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
Roskilde, , Denmark
Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana
Alexandroupoli, Evros, Greece
Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47
Athens, , Greece
1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.
Athens, , Greece
3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.
Athens, , Greece
Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari
Athens, , Greece
Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District
Abuja, , Nigeria
Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37
Warsaw, , Poland
Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
Singapore, , Singapore
Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
Badalona, Barcelona, Spain
Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80
Lleida, Leida, Spain
Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
Barcelona, , Spain
Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
Barcelona, , Spain
University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100
Zurich, Canton of Zurich, Switzerland
MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital
Entebbe, , Uganda
Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160
Gulu, , Uganda
Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill
Kampala, , Uganda
St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
Kampala, , Uganda
Lira Regional Referral Hospital (Site 634-605)
Lira, , Uganda
Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
Masaka, , Uganda
Royal Victoria Infirmary (Site 634-007), Queen Victoria Road
Newcastle upon Tyne, Northumbria, United Kingdom
Royal Free Hospital (Site 634-006), Pond Street, Hampstead
London, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)
London, , United Kingdom
Countries
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References
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ACTIV-3/TICO Study Group; Barkauskas C, Mylonakis E, Poulakou G, Young BE, Vock DM, Siegel L, Engen N, Grandits G, Mosaly NR, Vekstein AM, Rogers R, Shehadeh F, Kaczynski M, Mylona EK, Syrigos KN, Rapti V, Lye DC, Hui DS, Leither L, Knowlton KU, Jain MK, Marines-Price R, Osuji A, Overcash JS, Kalomenidis I, Barmparessou Z, Waters M, Zepeda K, Chen P, Torbati S, Kiweewa F, Sebudde N, Almasri E, Hughes A, Bhagani SR, Rodger A, Sandkovsky U, Gottlieb RL, Nnakelu E, Trautner B, Menon V, Lutaakome J, Matthay M, Robinson P, Protopapas K, Koulouris N, Kimuli I, Baduashvili A, Braun DL, Gunthard HF, Ramachandruni S, Kidega R, Kim K, Hatlen TJ, Phillips AN, Murray DD, Jensen TO, Padilla ML, Accardi EX, Shaw-Saliba K, Dewar RL, Teitelbaum M, Natarajan V, Laverdure S, Highbarger HC, Rehman MT, Vogel S, Vallee D, Crew P, Atri N, Schechner AJ, Pett S, Hudson F, Badrock J, Touloumi G, Brown SM, Self WH, North CM, Ginde AA, Chang CC, Kelleher A, Nagy-Agren S, Vasudeva S, Looney D, Nguyen HH, Sanchez A, Weintrob AC, Grund B, Sharma S, Reilly CS, Paredes R, Bednarska A, Gerry NP, Babiker AG, Davey VJ, Gelijns AC, Higgs ES, Kan V, Matthews G, Thompson BT, Legenne P, Chandra R, Lane HC, Neaton JD, Lundgren JD. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial. Ann Intern Med. 2022 Sep;175(9):1266-1274. doi: 10.7326/M22-1503. Epub 2022 Aug 9.
Provided Documents
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Document Type: Study Protocol: Trial H5 Protocol
Document Type: Study Protocol: Master Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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014/ACTIV-3/H5
Identifier Type: -
Identifier Source: org_study_id
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