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PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Primary Purpose

COVID-19

Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-07304814
Placebo
Remdesivir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure. Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (see Section H6.3.4). Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine. Pregnant women Nursing mothers 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 5 weeks of the study. 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 5 weeks of the study. Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism*. Prior to the initial futility assessment which is performed when approximately 150 patients have been enrolled on PF-07304814 and 150 on placebo, patients with a history of deep vein thrombosis or pulmonary embolism will be excluded. These patients will be eligible for the trial if the initial futility assessment is passed by this agent, and if risk-benefit is favorable based on an assessment of available data that is reviewed by the independent DSMB. These data will include treatment comparisons of thromboembolic events and coagulation markers, and any additional data from studies carried out by Pfizer.

Sites / Locations

  • Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
  • Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
  • Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
  • Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue
  • UC Davis Health (Site 203-004), 2315 Stockton Blvd.
  • VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
  • San Francisco VAMC (Site 074-002), 4150 Clement St.
  • National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
  • West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
  • MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
  • Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
  • Hillsborough County Health Department, University of South Florida (Site 032-001)
  • Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
  • Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
  • Massachusetts General Hospital (Site 202-002), 55 Fruit Street
  • Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
  • Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
  • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
  • Duke University Hospital (Site 301-006), 2301 Erwin Road
  • Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
  • Rhode Island Hospital (Site 080-036), 593 Eddy Street
  • The Miriam Hospital (Site 080-039), 164 Summit Ave.
  • Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
  • MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
  • MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
  • Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
  • UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
  • Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
  • University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
  • West Virginia University (Site 301-023), One Medical Center Drive
  • Aalborg Hospital (Site 625-005), Hobrovej 18
  • Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
  • Righospitalet (Site 625-006), Blegdamsvej 9,
  • Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
  • Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
  • Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
  • Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
  • Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
  • Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-07304814 plus SOC

Placebo plus SOC

Arm Description

PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion

Outcomes

Primary Outcome Measures

Time from randomization to sustained recovery
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Secondary Outcome Measures

All-cause mortality
Composite of time to sustained recovery and mortality
Days alive outside short-term acute care hospital
Pulmonary ordinal outcome
Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Pulmonary+ ordinal outcome
Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Incidence of clinical organ failure
Composite of death or serious clinical COVID-19 related events
Composite of cardiovascular events and thromboembolic events
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Incidence of infusion reactions
Composite of SAEs or death
Change in SARS-CoV-2 neutralizing antibody levels
Change in overall titers of antibodies
Change in neutralizing antibody levels
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14-day period.
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
Measured as: Alive at home for an uninterrupted 14-day period and no use of continuous supplemental oxygen at end of 14-day time period.

Full Information

First Posted
March 20, 2023
Last Updated
March 22, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Pfizer, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05780541
Brief Title
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Official Title
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H6: PF-07304814)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
The agent was withdrawn from development by the manufacturer after being placed on clinical hold by the US FDA.
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Pfizer, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6.
Detailed Description
This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of PF-07304814 in hospitalized patients infected with COVID-19. This is a randomized, blinded, controlled sub-study of PF-07304814 plus current standard of care (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 PF-07304814 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-07304814 plus SOC
Arm Type
Experimental
Arm Description
PF-07304814 250 mg per day for 5 days; administered as a constant rate IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Arm Title
Placebo plus SOC
Arm Type
Placebo Comparator
Arm Description
Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
PF-07304814
Intervention Description
PF-07304814 is a phosphate ester prodrug of PF-00835231 (active moiety), a potent and selective inhibitor of the SARS-CoV-2 3CLpro.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Commercially available 0.9% sodium chloride solution
Intervention Type
Biological
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
Veklury
Intervention Description
Antiviral agent
Primary Outcome Measure Information:
Title
Time from randomization to sustained recovery
Description
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Time Frame
Up to Day 90
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Through Day 90
Title
Composite of time to sustained recovery and mortality
Time Frame
Through Day 90
Title
Days alive outside short-term acute care hospital
Time Frame
Up to Day 90
Title
Pulmonary ordinal outcome
Description
Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Time Frame
Days 1-7, 14 and 28
Title
Pulmonary+ ordinal outcome
Description
Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Time Frame
Days 1-7
Title
Incidence of clinical organ failure
Time Frame
Through Day 28
Title
Composite of death or serious clinical COVID-19 related events
Time Frame
Through Day 90
Title
Composite of cardiovascular events and thromboembolic events
Time Frame
Through Day 90
Title
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Time Frame
Through Days 5 and 28
Title
Incidence of infusion reactions
Time Frame
Through Day 0
Title
Composite of SAEs or death
Time Frame
Through 18 months
Title
Change in SARS-CoV-2 neutralizing antibody levels
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Change in overall titers of antibodies
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Change in neutralizing antibody levels
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
Description
Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14-day period.
Time Frame
18 months
Title
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
Description
Measured as: Alive at home for an uninterrupted 14-day period and no use of continuous supplemental oxygen at end of 14-day time period.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Exclusion Criteria: Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure. Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (see Section H6.3.4). Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine. Pregnant women Nursing mothers 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 5 weeks of the study. 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 5 weeks of the study. Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism*. Prior to the initial futility assessment which is performed when approximately 150 patients have been enrolled on PF-07304814 and 150 on placebo, patients with a history of deep vein thrombosis or pulmonary embolism will be excluded. These patients will be eligible for the trial if the initial futility assessment is passed by this agent, and if risk-benefit is favorable based on an assessment of available data that is reviewed by the independent DSMB. These data will include treatment comparisons of thromboembolic events and coagulation markers, and any additional data from studies carried out by Pfizer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Lundgren, Prof.
Organizational Affiliation
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Neaton, Prof.
Organizational Affiliation
INSIGHT Statistical and Coordinating Centre, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC Davis Health (Site 203-004), 2315 Stockton Blvd.
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
San Francisco VAMC (Site 074-002), 4150 Clement St.
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Hillsborough County Health Department, University of South Florida (Site 032-001)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Duke University Hospital (Site 301-006), 2301 Erwin Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Rhode Island Hospital (Site 080-036), 593 Eddy Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital (Site 080-039), 164 Summit Ave.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29505
Country
United States
Facility Name
Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
West Virginia University (Site 301-023), One Medical Center Drive
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aalborg Hospital (Site 625-005), Hobrovej 18
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Righospitalet (Site 625-006), Blegdamsvej 9,
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

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