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STAMP: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

Sponsor
Adagio Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04805671
Collaborator
(none)
1,084
Enrollment
68
Locations
2
Arms
19.2
Anticipated Duration (Months)
15.9
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1084 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:
Treatment
Official Title:
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)
Actual Study Start Date :
Jul 26, 2021
Actual Primary Completion Date :
Feb 10, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ADG20 IM

Participants will be dosed on Day 1 with ADG20 IM

Drug: ADG20
Single dose of ADG20
Placebo Comparator: Placebo IM

Participants will be dosed on Day 1 with placebo IM

Drug: Normal saline
Single dose of normal saline

Outcome Measures

Primary Outcome Measures

  1. Incidence of COVID-19 related hospitalizations or all-cause death [Through Day 29]

  2. Incidence of treatment-emergent adverse events [Through day 29]

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

  4. Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) [Through Day 29]

  5. Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) [Through Day 29]

Secondary Outcome Measures

  1. Incidence of COVID-19 -related medically attended visits [Through Day 29]

  2. Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death [Through Day 29]

  3. Incidence of severe/critical COVID-19 or all cause death [Through Day 29]

  4. Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms [Through Day 29]

  5. Incidence of all-cause mortality [Through Day 29, Day 60 and Day 90]

  6. Time to sustained resolution of COVID-19 symptoms as measured in the Daily COVID-19 Symptom Diary [Through Day 29]

  7. Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR from saliva samples (and NP samples for Day 7) [Days 3, 5, 7, 11 and 14 (saliva); Day 7 (NP swab)]

  8. Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples [Through Day 29]

  9. Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling [on Day 7 (+/- 1)]

  10. SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7) [Days 5, 7, 11, 14, 21, and 29 (saliva); Day 7 (NP swab)]

  11. SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples [Baseline to Day 29]

  12. Incidence of treatment emergent adverse events [14 months]

  13. Number of participants with potentially clinically significant (PCS) changes from baseline in clinical laboratory test (PCS defined per statistical analysis plan) [14 Months]

  14. Number of participants with potentially clinically significant (PCS) changes from baseline in vital sign parameters (PCS defined per statistical analysis plan) [14 Months]

  15. Assessment of PK Parameter: Cmax for ADG20 [11 Months]

  16. Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 [11 Months]

  17. Assessment of PK Parameter: Area under the curve for ADG20 [11 Months]

  18. Assessment of PK Parameter: Clearance of ADG20 [11 Months]

  19. Assessment of PK Parameter: volume of distribution of ADG20 [11 Months]

  20. Assessment of PK Parameter: Half-life of ADG20 [11 Months]

  21. Incidence of ADA to ADG20 [11 months]

  22. Genotypic characterization of viral isolates for reduced susceptibility to ADG20 [Through Day 29]

Eligibility Criteria

Criteria

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

  • Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization

  • Has had symptoms consistent with COVID-19 with onset 5 days before randomization

  • Has one or more COVID-19-related signs or symptoms on the day of randomization

  • Phase 2: Is an adult aged 18 years and above

  • Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening

Exclusion Criteria:

  • Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.

  • Has severe COVID-19 or is on supplemental oxygen

  • Has a history of a positive SARS-CoV-2 antibody serology test

  • Has participated, within the last 30 days, in a clinical study involving an investigational intervention

  • Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study

NOTE: Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adagio Investigative Site Estomba Buenos Aires Argentina 8118
2 Adagio Investigative Site Munro Buenos Aires Argentina 1605
3 Adagio Investigative Site Río Cuarto Córdoba Argentina 5800
4 Adagio Investigative Site Rosario Santa Fe Argentina S2013DTC
5 Adagio Investigative Site Rosario Santa Fe Argentina S2013KDT
6 Adagio Investigative Site San Miguel De Tucumán Tucumán Argentina 4000
7 Adagio Investigative Site Mar del Plata Argentina B7602DCK
8 Adagio Investigative Site Salvador Bahia Brazil 2152
9 Adagio Investigative Site Taguatinga Distrito Federal Brazil 72119-900
10 Adagio Investigative Site Belo Horizonte Minas Gerais Brazil 30130-100
11 Adagio Investigative Site Passo Fundo Rio Grande Do Sul Brazil 99010-120
12 Adagio Investigative Site São Paulo Brazil 05403-000
13 Adagio Investigative Site São Paulo Brazil 13059-900
14 Adagio Investigative Site Dupnitsa Kjustendil Bulgaria 2600
15 Adagio Investigative Site Sofia Sofia-Grad Bulgaria 1510
16 Adagio Investigative Site Samokov Sofia Bulgaria 2000
17 Adagio Investigative Site Blagoevgrad Bulgaria 2700
18 Adagio Investigative Site Montana Bulgaria 3400
19 Adagio Investigative Site Pleven Bulgaria 5800
20 Adagio Investigative Site Ruse Bulgaria 7000
21 Adagio Investigative Site Stara Zagora Bulgaria 6003
22 Adagio Investigative Site Frankfurt am Main Hessen Germany 60596
23 Adagio Investigative Site Köln Nordrhein-Westfalen Germany 50668
24 Adagio Investigative Site Koblenz Rheinland-Pfalz Germany 56068
25 Adagio Investigative Site Berlin Germany 12203
26 Adagio Investigative Site Patra Achaïa Greece 26500
27 Adagio Investigative Site Athens Attiki Greece 106 76
28 Adagio Investigative Site Athens Attiki Greece 115 27
29 Adagio Investigative Site Athens Attiki Greece 115 28
30 Adagio Investigative Site Athens Attiki Greece 124 62
31 Adagio Investigative Site Heraklion Crete Greece 71110
32 Adagio Investigative Site Ioánnina Greece 45500
33 Adagio Investigative Site Níkaia Greece 184 54
34 Adagio Investigative Site Szeged Csongrád Hungary 6725
35 Adagio Investigative Site Székesfehérvár Fejér Hungary 8000
36 Adagio Investigative Site Debrecen Hajdú-Bihar Hungary 4031
37 Adagio Investigative Site Chisinau Moldova, Republic of MD-2025
38 Adagio Investigative Site Wroclaw Dolnoslaskie Poland 50-414
39 Adagio Investigative Site Wroclaw Dolnoslaskie Poland 53-149
40 Adagio Investigative Site Lódz Lódzkie Poland 90-302
41 Adagio Investigative Site Skierniewice Lódzkie Poland 96-100
42 Adagio Investigative Site Kraków Malopolskie Poland 31-501
43 Adagio Investigative Site Bucharest Bucuresti Romania 21105
44 Adagio Investigative Site Matjhabeng Free State South Africa 9459
45 Adagio Investigative Site Johannesburg Gauteng South Africa 1827
46 Adagio Investigative Site Johannesburg Gauteng South Africa 1862
47 Adagio Investigative Site Johannesburg Gauteng South Africa 2194
48 Adagio Investigative Site Kempton Park Gauteng South Africa 1619
49 Adagio Investigative Site Pretoria Gauteng South Africa 181
50 Adagio Investigative Site Rustenburg North - West South Africa 0299
51 Adagio Investigative Site Sol Plaatje Northern Cape South Africa 8301
52 Adagio Investigative Site Three Rivers Vereeniging South Africa 1938
53 Adagio Investigative Site Cape Town Western Cape South Africa 7130
54 Adagio Investigative Site Cape Town Western Cape South Africa 7530
55 Adagio Investigative Site Cape Town Western Cape South Africa 7570
56 Adagio Investigative Site George Western Cape South Africa 6529
57 Adagio Investigative Site Worcester Western Cape South Africa 6850
58 Adagio Investigative Site George South Africa 6530
59 Adagio Investigative Site Pretoria South Africa 0001
60 Adagio Investigative Site Dnipro Dnipropetrovs'ka Oblast Ukraine 49102
61 Adagio Investigative Site Ivano-Frankivsk Ivano-Frankivs'ka Oblast Ukraine 76018
62 Adagio Investigative Site Kherson Khersons'ka Oblast Ukraine 73000
63 Adagio Investigative Site Kharkiv Ukraine 61002
64 Adagio Investigative Site Kyiv Ukraine 1103
65 Adagio Investigative Site Kyiv Ukraine 3049
66 Adagio Investigative Site Kyiv Ukraine 4050
67 Adagio Investigative Site Kyïv Ukraine 03035
68 Adagio Investigative Site Kyïv Ukraine 04050

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:
NCT04805671
Other Study ID Numbers:
  • ADG20-TRMT-001
First Posted:
Mar 18, 2021
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 Aug 23, 2022