Evaluation of ADG20 for the Prevention of COVID-19 (EVADE)

A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: ADG20; Drug: Placebo

Detailed Description

Phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mAb ADG20 in the prevention of symptomatic COVID-19 in adults and adolescents with no known history of SARS-CoV-2 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a SARS-CoV-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to SARS-CoV-2 (pre-exposure prophylaxis). These cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.

• Study Type: Interventional
• Enrollment (Actual): 2582
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1426ABP
      • Invivyd Investigative Site
    • Mar Del Plata, Buenos Aires, Argentina, B7600FZO
      • Invivyd Investigative Site
    • Munro, Buenos Aires, Argentina, B1605FRE
      • Invivyd Investigative Site
    • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
      • Invivyd Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000
      • Invivyd Investigative Site
  • Sante Fe
    • Rosario, Sante Fe, Argentina, S2000
      • Invivyd Investigative Site
• Czechia
  • Ostrava, Czechia, 708 00
    • Invivyd Investigative Site
  • Praha, Czechia, 158 00
    • Invivyd Investigative Site
  • Rychnov Nad Kněžnou, Czechia, 516 01
    • Invivyd Investigative Site
• Georgia
  • Batumi, Georgia, 6000
    • Invivyd Investigative Site
  • Kutaisi, Georgia, 4600
    • Invivyd Investigative Site
  • Rust'avi, Georgia, 3700
    • Invivyd Investigative Site
  • Tbilisi, Georgia, 0179
    • Invivyd Investigative Site
  • Tbilisi, Georgia, 0180
    • Invivyd Investigative Site
  • Tbilisi, Georgia, 0186
    • Invivyd Investigative Site
  • Tbilisi, Georgia, 0197
    • Invivyd Investigative Site
• Germany
  • Berlin, Germany, 10629
    • Invivyd Investigative Site
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2025
    • Invivyd Investigative Site
• Poland
  • Kajetany, Poland, 05-830
    • Invivyd Investigative Site
  • Lublin, Poland, 20-412
    • Invivyd Investigative Site
  • Siedlce, Poland, 08-110
    • Invivyd Investigative Site
  • Skierniewice, Poland, 96-100
    • Invivyd Investigative Site
  • Warszawa, Poland, 02-793
    • Invivyd Investigative Site
  • Zamość, Poland, 22-400
    • Invivyd Investigative Site
  • Łódź, Poland, 90-302
    • Invivyd Investigative Site
  • Świdnica, Poland, 58-100
    • Invivyd Investigative Site
• Romania
  • Bucuresti, Romania, 021105
    • Invivyd Investigative Site
• Ukraine
  • Kyiv, Ukraine, 01103
    • Adagio Investigative Site
  • Kyiv, Ukraine, 01135
    • Invivyd Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Invivyd Investigative Site
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Invivyd Investigative Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72701
      • Invivyd Investigative Site
    • North Little Rock, Arkansas, United States, 72223
      • Invivyd Investigative Site
  • California
    • Banning, California, United States, 92220
      • Invivyd Investigative Site
    • Chula Vista, California, United States, 91911
      • Invivyd Investigative Site
    • Culver City, California, United States, 90230
      • Invivyd Investigative Site
    • Escondido, California, United States, 92025
      • Invivyd Investigative Site
    • Fullerton, California, United States, 92835
      • Invivyd Investigative Site
    • Long Beach, California, United States, 90806
      • Invivyd Investigative Site
    • Los Angeles, California, United States, 90036
      • Invivyd Investigative Site
    • Modesto, California, United States, 95350
      • Invivyd Investigative Site
    • Palm Springs, California, United States, 92262
      • Invivyd Investigative Site
    • San Diego, California, United States, 92103
      • Invivyd Investigative Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Invivyd Investigative Site
    • Edgewater, Florida, United States, 32132
      • Invivyd Investigative Site
    • Hialeah, Florida, United States, 33012
      • Invivyd Investigative Site
    • Miami, Florida, United States, 33155
      • Invivyd Investigative Site
    • Miami, Florida, United States, 33176
      • Invivyd Investigative Site
    • Miami, Florida, United States, 33186
      • Invivyd Investigative Site
    • Mount Dora, Florida, United States, 32757
      • Invivyd Investigative Site
    • North Miami Beach, Florida, United States, 33169
      • Invivyd Investigative Site
    • Ormond Beach, Florida, United States, 32174
      • Invivyd Investigative Site
    • Pembroke Pines, Florida, United States, 33026
      • Invivyd Investigative Site
    • Sunrise, Florida, United States, 33325
      • Invivyd Investigative Site
    • Tampa, Florida, United States, 33603
      • Invivyd Investigative Site
    • The Villages, Florida, United States, 32159
      • Invivyd Investigative Site
    • West Palm Beach, Florida, United States, 33409
      • Invivyd Investigative Site
  • Georgia
    • Hinesville, Georgia, United States, 31313
      • Invivyd Investigative Site
    • Lawrenceville, Georgia, United States, 30044
      • Invivyd Investigative Site
  • Hawaii
    • Pearl City, Hawaii, United States, 96782
      • Invivyd Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Invivyd Investigative Site
    • Oak Brook, Illinois, United States, 60523
      • Invivyd Investigative Site
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Invivyd Investigative Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Invivyd Investigative Site
    • New Orleans, Louisiana, United States, 70118
      • Invivyd Investigative Site
  • Maryland
    • Rockville, Maryland, United States, 20855
      • Invivyd Investigative Site
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Invivyd Investigative Site
  • Michigan
    • Caro, Michigan, United States, 48723
      • Invivyd Investigative Site
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Invivyd Investigative Site
  • Montana
    • Missoula, Montana, United States, 59808
      • Invivyd Investigative Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Invivyd Investigative Site
  • New York
    • New York, New York, United States, 11201
      • Invivyd Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Invivyd Investigative Site
    • Shelby, North Carolina, United States, 28150
      • Invivyd Investigative Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Invivyd Investigative Site
    • Cincinnati, Ohio, United States, 54242
      • Invivyd Investigative Site
    • Dresden, Ohio, United States, 43821
      • Invivyd Investigative Site
    • Middleburg Heights, Ohio, United States, 44130
      • Invivyd Investigative Site
  • Oklahoma
    • Yukon, Oklahoma, United States, 73099
      • Invivyd Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Invivyd Investigative Site
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Invivyd Investigative Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Invivyd Investigative Site
    • Milan, Tennessee, United States, 38358
      • Invivyd Investigative Site
    • Nashville, Tennessee, United States, 37203
      • Invivyd Investigative Site
  • Texas
    • Beaumont, Texas, United States, 77706
      • Invivyd Investigative Site
    • College Station, Texas, United States, 77845
      • Invivyd Investigative Site
    • Corpus Christi, Texas, United States, 78412
      • Invivyd Investigative Site
    • Houston, Texas, United States, 77022
      • Invivyd Investigative Site
    • Houston, Texas, United States, 77087
      • Invivyd Investigative Site
    • Hurst, Texas, United States, 76054
      • Invivyd Investigative Site
    • Mesquite, Texas, United States, 75149
      • Invivyd Investigative Site
    • Sugar Land, Texas, United States, 77479
      • Invivyd Investigative Site
  • Utah
    • Saint George, Utah, United States, 84790
      • Invivyd Investigative Site
    • West Jordan, Utah, United States, 84088
      • Invivyd Investigative Site
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Invivyd Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Tests negative for current or previous SARS-CoV-2 infection by RT-PCR and serology (Pre-exposure population only)

• Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:

  1. Post-exposure population: exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic test.
  2. Pre-exposure population: Occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to SARS-CoV-2.
• Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing

Exclusion Criteria:

• Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine, convalescent plasma, or mAb clinical trial any time prior to participation in the study.
• Receipt of any investigational product within 30 days or 5 half lives before the day of enrollment.
• Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. Fever is defined as a body temperature ≥38.0°C (≥100.4°F).
• Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing).

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADG20; Participants will be dosed on Day 1 with ADG20 IM	Drug: ADG20; Single dose of ADG20
Placebo Comparator: Placebo; Participants will be dosed on Day 1 with placebo IM	Drug: Placebo; Single dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)	RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)	RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Solicited Injection Site Reactions (PEP, PrEP)	Percentage of participants with at least one solicited injection site reaction	Day 1 through Day 4
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)	Any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment; includes solicited injection site reactions	Day 1 through 14 Months or 25Jul2022, whichever is earlier

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)	RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCRtest from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)	Participants with RT-PCR-confirmed symptomatic COVID-19 (protocol defined COVID-19 symptoms occurring within 14 days from the sample collection date of a positive central or local [in the absence of central test] RT-PCR, any COVID-19-related hospitalization with a positive local SARS-CoV-2 test [within 14 days], or all-cause death), central RT-PCR-confirmed SARS-CoV-2 infection, or central serology-confirmed SARS-CoV-2 infection with negative central serology at baseline.	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)	Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)	Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death)	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)	Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death)	Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)	Asymptomatic SARS-CoV-2 infection confirmed by RT-qPCR from nasal swab collected at Day 8 and Day 15. Viral load values reported as detected but below the lower quantification of the PCR assay (< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as > 7.1×10^7 copies/mL are imputed with 7.1×10^7 copies/mL (i.e., 7.85 log10 copies/mL).	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)	Maximum severity assessed from COVID-19-like illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)	Maximum severity assessed from COVID-19-like Illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)	Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR-confirmed symptomatic COVID-19 events, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)	Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR confirmed symptomatic COVID-19, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Percentage of Participants With a COVID-19 Related Hospitalization (PEP)		Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)		Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PEP)		Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PrEP)		Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PEP)		Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PrEP)		Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)	Viral load from COVID-19-like illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as > 7.1×10^7 copies/mL are imputed with 7.1×10^7 copies/mL (i.e., 7.85 log10 copies/mL).	Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)	Viral load from COVID-19-like Illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as > 7.1×10^7 copies/mL are imputed with 7.1×10^7 copies/mL (i.e., 7.85 log10 copies/mL).	Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)	PK samples collected at protocol-defined timepoints	Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)	PK samples collected at protocol-defined timepoints	Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)	Outcome measure is presented as cumulative probability expressed in percentage. RT-PCR-confirmed symptomatic COVID-19 event is defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.	An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)	Outcome measure is presented as cumulative probability expressed in percentage. RT-PCR-confirmed symptomatic COVID-19 event is defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.	An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)

Collaborators and Investigators

• Sponsor: Invivyd, Inc.

Publications and helpful links

General 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.
• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

Helpful Links

• Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE)

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adintrevimab, ADG20, COVID-19, prevention, prophylaxis
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ADG20-PREV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No