Back to results

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)

Primary Purpose

Covid19

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Remdesivir

Remdesivir Placebo

Aviptadil

Aviptadil Placebo

Corticosteroid

About this trial

This is an interventional treatment trial for Covid19 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

Eligibility Criteria

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

Inclusion Criteria:

Signed informed consent.
Requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes).
Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure).
SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization.
Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.

Exclusion Criteria:

Known allergy to investigational agent or vehicle.
More than 4 days since initiation of support for respiratory failure.
Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
Moribund patient (i.e. not expected to survive 24 hours).
Active use of "comfort care" or other hospice-equivalent standard of care.
Expected inability to participate in study procedures.
In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments.
Previous enrollment in TESICO

Agent-specific exclusion criteria

Prior receipt of any dose of remdesivir during present illness (remdesivir agent).
GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent).
ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent).
Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent).
Refractory hypotension (aviptadil agent).
Severe diarrhea (Aviptadil agent).
Current C. difficile infection (aviptadil agent).
Pregnancy or current breast-feeding (aviptadil agent).
End-stage liver disease (aviptadil agent).

Sites / Locations

Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
UCSF Fresno (Site 203-005), 155 N. Fresno Street
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street
Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.
Duke University Hospital (Site 301-006), 2301 Erwin Road
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740
Cleveland Clinic Fairview Hosptial (Site 207-005), 18101 Lorain Ave.
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.
The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue
Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road
Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
Houston Methodist Hospital (Site 301-028), 6565 Fannin Street
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
University of Texas Health Science Center (Site 203-006), 7000 Fannin St.
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
University of Utah Hospital (Site 211-002), 50 North Medical Drive
UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.
Harborview Medical Center (Site 208-001), 325 9th Ave.
Swedish Medical Center (Site 208-005), 747 Broadway
West Virginia University Medicine (Site 301-023), One Medical Center Drive

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Aviptadil + Remdesivir + SOC

Aviptadil + Remdesivir Placebo + SOC

Aviptadil Placebo + Remdesivir + SOC

Aviptadil Placebo + Remdesivir Placebo + SOC

Arm Description

Outcomes

Primary Outcome Measures

Recovery, assessed at 90 days

Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.

Secondary Outcome Measures

All-cause mortality

Time to death

Composite of time to recovery, days at home off new supplemental oxygen and time to death

Measured in number of days

Composite of alive, at home and off new supplemental oxygen

Composite of recovered, alive and not recovered, and dead

Recovery defined as alive, at home and off new supplemental oxygen

Time from randomization to recovery

Recovery defined as alive, at home and off oxygen (treating death as competing risk)

Days alive outside short-term acute care hospital

Using "last off" method.

Incidence of clinical organ failure or serious infections

Defined as any one or more of: Worsening respiratory dysfunction; cardiac and vascular dysfunction; renal dysfunction; hepatic dysfunction; neurological dysfunction, haematological dysfunction; serious infection

Composite of death, clinical organ failure or serious infections

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

Percentage of participants for whom infusion was interrupted or stopped prior to completion for any reason

Percentage of participants for whom infusion was interrupted or stopped prior to completion due to adverse event

Composite of hospital readmissions or death

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.

Time to hospital discharge from initial hospitalization

Composite of death or serious clinical COVID-19 related events

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.

Composite of SAEs or death

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

In category 4, 5 or 6 at Day 90 vs. in categories 1-3 at Day 90

Categories are 1 (Best): At home an off oxygen for ≥ 77 consecutive days; 2: At home and off oxygen for 49-76 consecutive days; 3: At home and off oxygen for 1-48 consecutive days; 4: Not hospitalized and either at home on oxygen or not at home; 5: Hospitalized for medical care or in hospice care; 6 (Worst): Dead.

In category 5 or 6 at Day 90 vs. in categories 1-4 at Day 90

Full Information

NCT ID

NCT04843761

First Posted

April 9, 2021

Last Updated

May 1, 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, NeuroRx, Inc., Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04843761

Brief Title

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Acronym

TESICO

Official Title

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

August 22, 2022 (Actual)

Study Completion Date

November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Detailed Description

This is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19. Trials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol. If an investigational agent shows superiority over placebo, SOC for the study of future investigational agents may be modified accordingly. The international trials within this protocol will be conducted in up to 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. The protocol is for a phase III platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against control within the same trial infrastructure. When more than one agent is being tested concurrently, participants may be randomly allocated across agents (as well as between the agent and its placebo) so the same control group can be shared, when feasible. In some situations, a factorial design may be used to study multiple agents. Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days. This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for an investigational agent versus placebo with use of the ordinal outcome. The planned sample size is 640 participants (320 per group) for each investigational agent/placebo. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio. Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO at enrollment. Other agent-specific stratification factors may be considered. Investigational agents suitable for testing in the inpatient setting will be prioritized based on in vitro data, preclinical data, phase I pharmacokinetic and safety data, and clinical data from completed and ongoing trials. In some cases, a vanguard cohort/initial pilot phase may be incorporated into the trial. An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

473 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aviptadil + Remdesivir + SOC

Arm Type

Experimental

Arm Title

Aviptadil + Remdesivir Placebo + SOC

Arm Type

Placebo Comparator

Arm Title

Aviptadil Placebo + Remdesivir + SOC

Arm Type

Experimental

Arm Title

Aviptadil Placebo + Remdesivir Placebo + SOC

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Remdesivir

Intervention Description

Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.

Intervention Type

Drug

Intervention Name(s)

Remdesivir Placebo

Intervention Description

Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.

Intervention Type

Biological

Intervention Name(s)

Aviptadil

Other Intervention Name(s)

Vasoactive Intestinal Peptide, VIP

Intervention Description

Administered by IV infusion over 12 hours per day for 3 days. Participants are no longer being randomized to this intervention.

Intervention Type

Drug

Intervention Name(s)

Aviptadil Placebo

Intervention Description

Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.

Intervention Type

Drug

Intervention Name(s)

Corticosteroid

Intervention Description

In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.

Primary Outcome Measure Information:

Title

Recovery, assessed at 90 days

Description

Time Frame

Thru Day 90

Secondary Outcome Measure Information:

Title

All-cause mortality

Time Frame

Thru Day 90

Title

Time to death

Time Frame

Thru Day 90

Title

Composite of time to recovery, days at home off new supplemental oxygen and time to death

Description

Measured in number of days

Time Frame

Thru Day 90

Title

Composite of alive, at home and off new supplemental oxygen

Time Frame

Thru Day 90

Title

Composite of recovered, alive and not recovered, and dead

Description

Recovery defined as alive, at home and off new supplemental oxygen

Time Frame

Thru Day 90

Title

Time from randomization to recovery

Description

Recovery defined as alive, at home and off oxygen (treating death as competing risk)

Time Frame

Thru Day 90

Title

Days alive outside short-term acute care hospital

Description

Using "last off" method.

Time Frame

Up to Day 90

Title

Incidence of clinical organ failure or serious infections

Description

Time Frame

Thru Day 28

Title

Composite of death, clinical organ failure or serious infections

Time Frame

Thru Day 90

Title

Composite of cardiovascular events and thromboembolic events

Time Frame

Thru Day 28

Title

Composite of cardiovascular events and thromboembolic events

Time Frame

Thru Day 90

Title

Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death

Time Frame

Thru Days 5 and 28

Title

Incidence of infusion reactions

Time Frame

Thru Day 180

Title

Percentage of participants for whom infusion was interrupted or stopped prior to completion for any reason

Time Frame

Thru Day 90

Title

Percentage of participants for whom infusion was interrupted or stopped prior to completion due to adverse event

Time Frame

Thru Day 90

Title

Composite of hospital readmissions or death

Time Frame

Thru Day 180

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

Title

Time to hospital discharge from initial hospitalization

Time Frame

Thru Day 180

Title

Composite of death or serious clinical COVID-19 related events

Time Frame

Thru 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

Composite of SAEs or death

Time Frame

Thru Day 180

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

Thru Day 180

Title

In category 4, 5 or 6 at Day 90 vs. in categories 1-3 at Day 90

Description

Time Frame

Day 90

Title

In category 5 or 6 at Day 90 vs. in categories 1-4 at Day 90

Description

Time Frame

Day 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed informed consent. Requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes). Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure). SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization. Respiratory failure is believed to be due to SARS-CoV-2 pneumonia. Exclusion Criteria: Known allergy to investigational agent or vehicle. More than 4 days since initiation of support for respiratory failure. Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion). Moribund patient (i.e. not expected to survive 24 hours). Active use of "comfort care" or other hospice-equivalent standard of care. Expected inability to participate in study procedures. In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments. Previous enrollment in TESICO Agent-specific exclusion criteria Prior receipt of any dose of remdesivir during present illness (remdesivir agent). GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent). ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent). Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent). Refractory hypotension (aviptadil agent). Severe diarrhea (Aviptadil agent). Current C. difficile infection (aviptadil agent). Pregnancy or current breast-feeding (aviptadil agent). End-stage liver disease (aviptadil agent).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Brown, MD

Organizational Affiliation

Intermountain Medical Center/University of Utah

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Prof. James Neaton

Organizational Affiliation

INSIGHT Statistical and Coordinating Centre, University of Minnesota

Official's Role

Study Chair

Facility Information:

Facility Name

Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

UCSF Fresno (Site 203-005), 155 N. Fresno Street

City

Fresno

State/Province

California

ZIP/Postal Code

93701

Country

United States

Facility Name

VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street

City

Loma Linda

State/Province

California

ZIP/Postal Code

92357

Country

United States

Facility Name

Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20422

Country

United States

Facility Name

Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

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

Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

Facility Name

Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Montefiore Medical Center - Weiler campus (Site 206-003), 111 E. 210th Street

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.

City

New York

State/Province

New York

ZIP/Postal Code

10032

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

Wake Forest Baptist Health (Site 210-001), Medical Center Blvd

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Cleveland Clinic Fairview Hosptial (Site 207-005), 18101 Lorain Ave.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44111

Country

United States

Facility Name

Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road

City

Garfield Heights

State/Province

Ohio

ZIP/Postal Code

44125

Country

United States

Facility Name

Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239-3098

Country

United States

Facility Name

Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

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

Houston Methodist Hospital (Site 301-028), 6565 Fannin Street

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

University of Texas Health Science Center (Site 203-006), 7000 Fannin St.

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

University of Utah Hospital (Site 211-002), 50 North Medical Drive

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Harborview Medical Center (Site 208-001), 325 9th Ave.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Swedish Medical Center (Site 208-005), 747 Broadway

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

West Virginia University Medicine (Site 301-023), One Medical Center Drive

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

URL

https://www.cdc.gov/coronavirus/2019-nCoV/index.html

Description

CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website

URL

https://www.niaid.nih.gov/clinical-trials/participant-guide

Description

A Participant's Guide to Clinical Trials (NIAID)

URL

https://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial

Description

Find a Clinical Trial (NIAID)

URL

https://www.niaid.nih.gov/clinical-trials

Description

Clinical Trials at NIAID

URL

https://www.niaid.nih.gov/

Description

National Institute for Allergy and Infectious Diseases (NIAID)

URL

https://www.covid19treatmentguidelines.nih.gov/

Description

NIH COVID-19 treatment guidelines

URL

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/patient-management

Description

WHO COVID-19 treatment guidelines

Learn more about this trial

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

We'll reach out to this number within 24 hrs