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EVADE: Evaluation of ADG20 for the Prevention of COVID-19

Sponsor
Adagio Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04859517
Collaborator
(none)
6,412
Enrollment
95
Locations
2
Arms
22.4
Anticipated Duration (Months)
67.5
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

This is a 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 will be 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 will enrich for participants whose advanced age (≥55 years old) or health status places them at risk for severe COVID-19 or COVID-19 complications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6412 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlledRandomized, double-blind, placebo-controlled
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study.
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Apr 27, 2021
Actual Primary Completion Date :
Apr 11, 2022
Anticipated Study Completion Date :
Mar 11, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [Through Day 28]

    Post-exposure prophylaxis (PEP) population

  2. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [Through 3 months]

    Pre-exposure prophylaxis (PrEP) population

  3. Incidence of solicited injection site reactions [Through Day 4]

    PEP and PrEP populations

  4. Incidence of treatment emergent adverse events [Through 14 months]

    PEP and PrEP populations

Secondary Outcome Measures

  1. Proportion of participants with RT-PCR confirmed symptomatic COVID-19 [Through 3 months]

    PEP population

  2. Proportion of participants with SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [Through Day 28 (PEP only) and 3 months (PrEP)]

    PEP and PrEP populations.

  3. Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR [On Days 8 and 15 after randomization]

    PEP population

  4. Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology [On Day 28 (PEP) and 6 months (PrEP)]

    PEP and PrEP populations

  5. Peak post-baseline SARS-CoV-2 viral load as measured by RT-qPCR in participants with asymptomatic SARS-CoV-2 infection detected by qRT-PCR at baseline via surveillance [Through Day 15]

    PEP population

  6. SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants [Through Day 15]

    PEP population

  7. Proportion of participants with RT-PCR confirmed mild, moderate, or severe/critical COVID-19 [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  8. Time to sustained resolution of COVID-19 symptoms [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  9. Proportion of participants with at least 1 COVID-19 related medically attended outpatient visit [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  10. Proportion of participants with a COVID-19 related hospitalization [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  11. Incidence of COVID-19 related mortality [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  12. Incidence of all cause mortality [Through COVID-19-like illness Day 28]

    PEP and PrEP populations

  13. Viral load as assessed by RT-qPCR in participants with COVID-19-like illness [CLI Day 1 sample]

    PEP and PrEP populations

  14. Assessment of PK Parameter: Cmax for ADG20 [12 months]

    PEP and PrEP populations

  15. Assessment of PK Parameter: Area under the curve for ADG20 [12 months]

    PEP and PrEP populations

  16. Assessment of PK Parameter: Half-life of ADG20 [12 months]

    PEP and PrEP populations

  17. Assessment of PK Parameter: Clearance of ADG20 [12 months]

    PEP and PrEP populations

  18. Assessment of PK Parameter: volume of distribution of ADG20 [12 months]

    PEP and PrEP populations

  19. Incidence of ADA to ADG20 [12 months]

    PEP and PrEP populations

  20. Time from randomization to first RT-PCR-confirmed symptomatic COVID-19 [Through Day 28 (PEP); through 3 months]

    PEP and PrEP populations

  21. Time from randomization to first SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [Through Day 28 (PEP); through 3 months]

    PEP and PrEP populations

  22. Probability of RT-PCR-confirmed symptomatic COVID-19 [Through Day 28 (PEP); through 3 months]

    PEP and PrEP populations

  23. Probability of SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology [Through Day 28 (PEP); through 3 months]

    PEP and PrEP populations

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adagio Investigative Site Birmingham Alabama United States 35209
2 Adagio Investigative Site Tucson Arizona United States 85745
3 Adagio Investigative Site Fayetteville Arkansas United States 72701
4 Adagio Investigative Site North Little Rock Arkansas United States 72223
5 Adagio Investigative Site Banning California United States 92220
6 Adagio Investigative Site Chula Vista California United States 91911
7 Adagio Investigative Site Culver City California United States 90230
8 Adagio Investigative Site Escondido California United States 92025
9 Adagio Investigative Site Fullerton California United States 92835
10 Adagio Investigative Site Long Beach California United States 90806
11 Adagio Investigative Site Los Angeles California United States 90036
12 Adagio Investigative Site Modesto California United States 95350
13 Adagio Investigative Site Palm Springs California United States 92262
14 Adagio Investigative Site San Diego California United States 92103
15 Adagio Investigative Site Clearwater Florida United States 33756
16 Adagio Investigative Site Edgewater Florida United States 32132
17 Adagio Investigative Site Hialeah Florida United States 33012
18 Adagio Investigative Site Miami Florida United States 33155
19 Adagio Investigative Site Miami Florida United States 33176
20 Adagio Investigative Site Miami Florida United States 33186
21 Adagio Investigative Site Mount Dora Florida United States 32757
22 Adagio Investigative Site North Miami Beach Florida United States 33169
23 Adagio Investigative Site Ormond Beach Florida United States 32174
24 Adagio Investigative Site Pembroke Pines Florida United States 33026
25 Adagio Investigative Site Sunrise Florida United States 33325
26 Adagio Investigative Site Tampa Florida United States 33603
27 Adagio Investigative Site The Villages Florida United States 32159
28 Adagio Investigative Site West Palm Beach Florida United States 33409
29 Adagio Investigative Site Hinesville Georgia United States 31313
30 Adagio Investigative Site Lawrenceville Georgia United States 30044
31 Adagio Investigative Site Pearl City Hawaii United States 96782
32 Adagio Investigative Site Chicago Illinois United States 60607
33 Adagio Investigative Site Oak Brook Illinois United States 60523
34 Adagio Investigative Site Owensboro Kentucky United States 42303
35 Adagio Investigative Site Marrero Louisiana United States 70072
36 Adagio Investigative Site New Orleans Louisiana United States 70118
37 Adagio Investigative Site Rockville Maryland United States 20855
38 Adagio Investigative Site Burlington Massachusetts United States 01803
39 Adagio Investigative Site Caro Michigan United States 48723
40 Adagio Investigative Site Grosse Pointe Woods Michigan United States 48236
41 Adagio Investigative Site Missoula Montana United States 59808
42 Adagio Investigative Site Albuquerque New Mexico United States 87102
43 Adagio Investigative Site New York New York United States 11201
44 Adagio Investigative Site Charlotte North Carolina United States 28208
45 Adagio Investigative Site Shelby North Carolina United States 28150
46 Adagio Investigative Site Beachwood Ohio United States 44122
47 Adagio Investigative Site Cincinnati Ohio United States 54242
48 Adagio Investigative Site Dresden Ohio United States 43821
49 Adagio Investigative Site Middleburg Heights Ohio United States 44130
50 Adagio Investigative Site Yukon Oklahoma United States 73099
51 Adagio Investigative Site Medford Oregon United States 97504
52 Adagio Investigative Site West Columbia South Carolina United States 29169
53 Adagio Investigative Site Jackson Tennessee United States 38305
54 Adagio Investigative Site Milan Tennessee United States 38358
55 Adagio Investigative Site Nashville Tennessee United States 37203
56 Adagio Investigative Site Beaumont Texas United States 77706
57 Adagio Investigative Site College Station Texas United States 77845
58 Adagio Investigative Site Corpus Christi Texas United States 78412
59 Adagio Investigative Site Houston Texas United States 77022
60 Adagio Investigative Site Houston Texas United States 77087
61 Adagio Investigative Site Hurst Texas United States 76054
62 Adagio Investigative Site Mesquite Texas United States 75149
63 Adagio Investigative Site Sugar Land Texas United States 77479
64 Adagio Investigative Site Saint George Utah United States 84790
65 Adagio Investigative Site West Jordan Utah United States 84088
66 Adagio Investigative Site Richmond Virginia United States 23226
67 Adagio Investigative Site Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1426ABP
68 Adagio Investigative Site Mar Del Plata Buenos Aires Argentina B7600FZO
69 Adagio Investigative Site Munro Buenos Aires Argentina B1605FRE
70 Adagio Investigative Site Ramos Mejía Buenos Aires Argentina B1704ETD
71 Adagio Investigative Site Rosario Santa Fe Argentina S2000
72 Adagio Investigative Site Rosario Sante Fe Argentina S2000
73 Adagio Investigative Site Ostrava Czechia 708 00
74 Adagio Investigative Site Praha Czechia 158 00
75 Adagio Investigative Site Rychnov Nad Kněžnou Czechia 516 01
76 Adagio Investigative Site Batumi Georgia 6000
77 Adagio Investigative Site Kutaisi Georgia 4600
78 Adagio Investigative Site Rust'avi Georgia 3700
79 Adagio Investigative Site Tbilisi Georgia 0179
80 Adagio Investigative Site Tbilisi Georgia 0180
81 Adagio Investigative Site Tbilisi Georgia 0186
82 Adagio Investigative Site Tbilisi Georgia 0197
83 Adagio Investigative Site Berlin Germany 10629
84 Adagio Investigative Site Chisinau Moldova, Republic of 2025
85 Adagio Investigative Site Kajetany Poland 05-830
86 Adagio Investigative Site Lublin Poland 20-412
87 Adagio Investigative Site Siedlce Poland 08-110
88 Adagio Investigative Site Skierniewice Poland 96-100
89 Adagio Investigative Site Warszawa Poland 02-793
90 Adagio Investigative Site Zamość Poland 22-400
91 Adagio Investigative Site Łódź Poland 90-302
92 Adagio Investigative Site Świdnica Poland 58-100
93 Adagio Investigative Site Bucuresti Romania 021105
94 Adagio Investigative Site Kyiv Ukraine 01103
95 Adagio Investigative Site Kyiv Ukraine 01135

Sponsors and Collaborators

  • Adagio Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adagio Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04859517
Other Study ID Numbers:
  • ADG20-PREV-001
First Posted:
Apr 26, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jul 25, 2022