COVID-19Phase 2/3EVADENCT04859517

Evaluation of ADG20 for the Prevention of COVID-19

A Phase 2/3 study testing ADG20 in people with COVID-19, run by Invivyd, Inc. at 95 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 12 years and older
Conditions the study is for: COVID-19
What is being tested?: ADG20
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,582 participants
Where: 95 sitesin 9 countries
Study dates: 27 Apr 2021to 4 Nov 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:
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.
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

Who cannot join

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

Trial locations and contacts

95 sites in 9 countries.

Country

City, postcode or hospital

95 sites in 9 countries

United States66 sites

Invivyd Investigative Site
Albuquerque, New Mexico, 87102
Invivyd Investigative Site
Banning, California, 92220
Invivyd Investigative Site
Beachwood, Ohio, 44122
Invivyd Investigative Site
Beaumont, Texas, 77706
Invivyd Investigative Site
Birmingham, Alabama, 35209
Invivyd Investigative Site
Burlington, Massachusetts, 01803
Invivyd Investigative Site
Caro, Michigan, 48723
Invivyd Investigative Site
Charlotte, North Carolina, 28208
Invivyd Investigative Site
Chicago, Illinois, 60607
Invivyd Investigative Site
Chula Vista, California, 91911
Invivyd Investigative Site
Cincinnati, Ohio, 54242
Invivyd Investigative Site
Clearwater, Florida, 33756
Invivyd Investigative Site
College Station, Texas, 77845
Invivyd Investigative Site
Corpus Christi, Texas, 78412
Invivyd Investigative Site
Culver City, California, 90230
Invivyd Investigative Site
Dresden, Ohio, 43821
Invivyd Investigative Site
Edgewater, Florida, 32132
Invivyd Investigative Site
Escondido, California, 92025
Invivyd Investigative Site
Fayetteville, Arkansas, 72701
Invivyd Investigative Site
Fullerton, California, 92835
Invivyd Investigative Site
Grosse Pointe Woods, Michigan, 48236
Invivyd Investigative Site
Hialeah, Florida, 33012
Invivyd Investigative Site
Hinesville, Georgia, 31313
Invivyd Investigative Site
Houston, Texas, 77022
Invivyd Investigative Site
Houston, Texas, 77087
Invivyd Investigative Site
Hurst, Texas, 76054
Invivyd Investigative Site
Jackson, Tennessee, 38305
Invivyd Investigative Site
Lawrenceville, Georgia, 30044
Invivyd Investigative Site
Long Beach, California, 90806
Invivyd Investigative Site
Los Angeles, California, 90036
Invivyd Investigative Site
Marrero, Louisiana, 70072
Invivyd Investigative Site
Medford, Oregon, 97504
Invivyd Investigative Site
Mesquite, Texas, 75149
Invivyd Investigative Site
Miami, Florida, 33155
Invivyd Investigative Site
Miami, Florida, 33176
Invivyd Investigative Site
Miami, Florida, 33186
Invivyd Investigative Site
Middleburg Heights, Ohio, 44130
Invivyd Investigative Site
Milan, Tennessee, 38358
Invivyd Investigative Site
Missoula, Montana, 59808
Invivyd Investigative Site
Modesto, California, 95350
Invivyd Investigative Site
Mt. Dora, Florida, 32757
Invivyd Investigative Site
Nashville, Tennessee, 37203
Invivyd Investigative Site
New Orleans, Louisiana, 70118
Invivyd Investigative Site
New York, New York, 11201
Invivyd Investigative Site
North Little Rock, Arkansas, 72223
Invivyd Investigative Site
North Miami Beach, Florida, 33169
Invivyd Investigative Site
Oak Brook, Illinois, 60523
Invivyd Investigative Site
Ormond Beach, Florida, 32174
Invivyd Investigative Site
Owensboro, Kentucky, 42303
Invivyd Investigative Site
Palm Springs, California, 92262
Invivyd Investigative Site
Pearl City, Hawaii, 96782
Invivyd Investigative Site
Pembroke Pines, Florida, 33026
Invivyd Investigative Site
Richmond, Virginia, 23226
Invivyd Investigative Site
Rockville, Maryland, 20855
Invivyd Investigative Site
San Diego, California, 92103
Invivyd Investigative Site
Shelby, North Carolina, 28150
Invivyd Investigative Site
St. George, Utah, 84790
Invivyd Investigative Site
Sugar Land, Texas, 77479
Invivyd Investigative Site
Sunrise, Florida, 33325
Invivyd Investigative Site
Tampa, Florida, 33603
Invivyd Investigative Site
The Villages, Florida, 32159
Invivyd Investigative Site
Tucson, Arizona, 85745
Invivyd Investigative Site
West Columbia, South Carolina, 29169
Invivyd Investigative Site
West Jordan, Utah, 84088
Invivyd Investigative Site
West Palm Beach, Florida, 33409
Invivyd Investigative Site
Yukon, Oklahoma, 73099

Other trials in United States

Poland8 sites

Invivyd Investigative Site
Kajetany, 05-830
Invivyd Investigative Site
Lodz, 90-302
Invivyd Investigative Site
Lublin, 20-412
Invivyd Investigative Site
Siedlce, 08-110
Invivyd Investigative Site
Skierniewice, 96-100
Invivyd Investigative Site
Swidnica, 58-100
Invivyd Investigative Site
Warsaw, 02-793
Invivyd Investigative Site
Zamość, 22-400

Other trials in Poland

Georgia7 sites

Invivyd Investigative Site
Batumi, 6000
Invivyd Investigative Site
Kutaisi, 4600
Invivyd Investigative Site
Rustavi, 3700
Invivyd Investigative Site
Tbilisi, 0179
Invivyd Investigative Site
Tbilisi, 0180
Invivyd Investigative Site
Tbilisi, 0186
Invivyd Investigative Site
Tbilisi, 0197

Other trials in Georgia

Argentina6 sites

Invivyd Investigative Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ABP
Invivyd Investigative Site
Mar del Plata, Buenos Aires, B7600FZO
Invivyd Investigative Site
Munro, Buenos Aires, B1605FRE
Invivyd Investigative Site
Ramos Mejía, Buenos Aires, B1704ETD
Invivyd Investigative Site
Rosario, Santa Fe Province, S2000
Invivyd Investigative Site
Rosario, Sante Fe, S2000

Other trials in Argentina

Czechia3 sites

Invivyd Investigative Site
Ostrava, 708 00
Invivyd Investigative Site
Prague, 158 00
Invivyd Investigative Site
Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Ukraine2 sites

Adagio Investigative Site
Kyiv, 01103
Invivyd Investigative Site
Kyiv, 01135

Other trials in Ukraine

Germany1 site

Invivyd Investigative Site
Berlin, 10629

Other trials in Germany

Moldova1 site

Invivyd Investigative Site
Chisinau, 2025

Other trials in Moldova

Romania1 site

Invivyd Investigative Site
Bucharest, 021105

Other trials in Romania

About this study

Official title: 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.

Read the 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.

Conditions: COVID-19
Being tested: ADG20, Placebo
Keywords: Adintrevimab, ADG20, COVID-19, prevention, prophylaxis
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADG20Drug
Single dose of ADG20
PlaceboDrug
Single dose of placebo

Study groups in NCT04859517
Study group	Role	What they receive
ADG20	Experimental	Participants will be dosed on Day 1 with ADG20 IM Receives: Drug: ADG20
Placebo	Placebo comparator	Participants will be dosed on Day 1 with placebo IM Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 1 through 14 Months or 25Jul2022, whichever is earlier

Secondary outcomes (22)

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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)
Measured: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PEP)
Measured: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PrEP)
Measured: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PEP)
Measured: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PrEP)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 20214 Nov 2022

First posted26 Apr 2021
Study start27 Apr 2021
Primary completion4 Nov 2022
Study completion4 Nov 2022

Why it stopped: All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, double-blind, placebo-controlled
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,582 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04859517
Sponsor's protocol ID: ADG20-PREV-001
Acronym: EVADE
Status last verified: Apr 2024
First submitted: 21 Apr 2021
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ison MG, Weinstein DF, Dobryanska M, Holmes A, Phelan AM, Li Y, Gupta D, Narayan K, Tosh K, Hershberger E, Connolly LE, Yalcin I, Campanaro E, Hawn P, Schmidt P; EVADE Study Group. Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE). Open Forum Infect Dis. 2023 Jun 13;10(7):ofad314. doi: 10.1093/ofid/ofad314. eCollection 2023 Jul.
PubMed 37496612
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.
PubMed 35713300
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04859517
Acronym / sponsor ID: EVADE / ADG20-PREV-001
Conditions: COVID-19
Keywords: Adintrevimab, ADG20, COVID-19, prevention, prophylaxis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.
Enrolment: 2,582 participants (actual)
Lead sponsor: Invivyd, Inc.Industry (pharma, biotech, devices)
Study start: 27 Apr 2021 (actual)
Primary completion: 4 Nov 2022 (actual)
Study completion: 4 Nov 2022 (actual)
First posted: 26 Apr 2021 (actual)
Results: Posted 20 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, double-blind, placebo-controlled

Arm	Type	Receives
ADG20	Experimental	Drug: ADG20Participants will be dosed on Day 1 with ADG20 IM
Placebo	Placebo comparator	Drug: PlaceboParticipants will be dosed on Day 1 with placebo IM

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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:
Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADG20Single dose of ADG20	Drug	ADG20
PlaceboSingle dose of placebo	Drug	Placebo

Primary outcome

Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
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.
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
Time frame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
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.
Solicited Injection Site Reactions (PEP, PrEP)
Time frame: Day 1 through Day 4
Percentage of participants with at least one solicited injection site reaction
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)
Time frame: Day 1 through 14 Months or 25Jul2022, whichever is earlier
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

22 secondary outcomes

Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)
Time frame: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PrEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PrEP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)
Time frame: 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)
Time frame: 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)
Time frame: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)

Results and safety

Results posted to the registry on 20 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADG20 IM - Cohort A	245	32
Placebo IM - Cohort A	242	35
ADG20 IM - Cohort B	1,048	226
Placebo IM - Cohort B	1,047	236

Primary outcome: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)

Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier. Count of participants. Unit: Participants

Measure	ADG20 IM - Cohort A n = 175	Placebo IM - Cohort A n = 176
Value	3	12

ADG20 IM - Cohort A vs Placebo IM - Cohort A: Risk Difference (RD): -5.0 (95% CI -8.87 to -1.08), p = 0.0123, Regression, Logistic

Population analysed: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.

Primary outcome: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)

Time frame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier. Count of participants. Unit: Participants

Measure	ADG20 IM - Cohort B n = 752	Placebo IM - Cohort B n = 728
Value	12	40

ADG20 IM - Cohort B vs Placebo IM - Cohort B: Risk Difference (RD): -3.9 (95% CI -5.75 to -2.01), p <0.0001, Regression, Logistic

Population analysed: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.

Primary outcome: Solicited Injection Site Reactions (PEP, PrEP)

Time frame: Day 1 through Day 4. Count of participants. Unit: Participants

Measure	ADG20 IM - Cohort A n = 240	Placebo IM - Cohort A n = 241	ADG20 IM - Cohort B n = 1001	Placebo IM - Cohort B n = 1001
Value	12	7	75	73

Population analysed: Participants who received any amount of study drug

Primary outcome: Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)

Time frame: Day 1 through 14 Months or 25Jul2022, whichever is earlier. Count of participants. Unit: Participants

Measure	ADG20 IM - Cohort A n = 240	Placebo IM - Cohort A n = 241	ADG20 IM - Cohort B n = 1001	Placebo IM - Cohort B n = 1001
Value	42	51	399	362

Population analysed: Participants who received any amount of study drug

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADG20 IM - Cohort A	4 of 240 (1.7%)	0 of 240 (0%)	0 of 240
Placebo IM - Cohort A	8 of 241 (3.3%)	0 of 241 (0%)	2 of 241
ADG20 IM - Cohort B	46 of 1,001 (4.6%)	126 of 1,001 (12.6%)	3 of 1,001
Placebo IM - Cohort B	46 of 1,001 (4.6%)	123 of 1,001 (12.3%)	6 of 1,001

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37496612Ison MG, Weinstein DF, Dobryanska M, Holmes A, Phelan AM, Li Y, Gupta D, Narayan K, Tosh K, Hershberger E, Connolly LE, Yalcin I, Campanaro E, Hawn P, Schmidt P; EVADE Study Group. Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE). Open Forum Infect Dis. 2023 Jun 13;10(7):ofad314. doi: 10.1093/ofid/ofad314. eCollection 2023 Jul.
Derived from this study: PubMed 35713300Hirsch 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.
Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

95 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ADG20 in people with COVID-19, run by Invivyd, Inc. at 95 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Poland, Georgia, Argentina, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) (time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04859517, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.