Clinical trial NCT04805671: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Invivyd, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 399
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of COVID-19 Related Hospitalizations or All-cause Death
timeFrame: Through Day 29
measure: Incidence of Treatment-emergent Adverse Events
timeFrame: Through day 29
measure: Incidence of Solicited Injection Site Reactions
timeFrame: Through Day 4
measure: Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)
timeFrame: Through Day 29
measure: Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)
timeFrame: Through Day 29
Secondary outcomes:
measure: Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death
timeFrame: Through Day 29
measure: Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death
timeFrame: Through Day 29
measure: Incidence of Severe/Critical COVID-19 or All Cause Death
timeFrame: Through Day 29
measure: Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms
timeFrame: Through Day 29
measure: Incidence of All-cause Mortality
timeFrame: Through Day 90
measure: Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary
timeFrame: Through Day 29
measure: Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1)
timeFrame: Day 7 (±1)
measure: Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples
timeFrame: Through Day 29
measure: Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7
timeFrame: on Day 7 (+/- 1 Day)
measure: SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7)
timeFrame: Days 5, 7, 11, 14, 21, and 29 (saliva)
measure: SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples
timeFrame: Baseline to Day 29
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: 14 months
measure: Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)
timeFrame: 14 Months
measure: Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)
timeFrame: 14 Months
measure: Incidence of ADA to ADG20
timeFrame: 11 months
measure: Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations)
timeFrame: Through Day 29
Other outcomes:
Locations:
city: Estomba
country: Argentina
facility: Adagio Investigative Site
state: Buenos Aires
city: Munro
country: Argentina
facility: Adagio Investigative Site
state: Buenos Aires
city: Río Cuarto
country: Argentina
facility: Adagio Investigative Site
state: Córdoba
city: Rosario
country: Argentina
facility: Adagio Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Adagio Investigative Site
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Adagio Investigative Site
state: Tucumán
city: Mar del Plata
country: Argentina
facility: Adagio Investigative Site
city: Salvador
country: Brazil
facility: Adagio Investigative Site
state: Bahia
city: Taguatinga
country: Brazil
facility: Adagio Investigative Site
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Adagio Investigative Site
state: Minas Gerais
city: Passo Fundo
country: Brazil
facility: Adagio Investigative Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Adagio Investigative Site
city: São Paulo
country: Brazil
facility: Adagio Investigative Site
city: Dupnitsa
country: Bulgaria
facility: Adagio Investigative Site
state: Kjustendil
city: Sofia
country: Bulgaria
facility: Adagio Investigative Site
state: Sofia-Grad
city: Samokov
country: Bulgaria
facility: Adagio Investigative Site
state: Sofia
city: Blagoevgrad
country: Bulgaria
facility: Adagio Investigative Site
city: Montana
country: Bulgaria
facility: Adagio Investigative Site
city: Pleven
country: Bulgaria
facility: Adagio Investigative Site
city: Ruse
country: Bulgaria
facility: Adagio Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Adagio Investigative Site
city: Frankfurt am Main
country: Germany
facility: Adagio Investigative Site
state: Hessen
city: Köln
country: Germany
facility: Adagio Investigative Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Adagio Investigative Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Adagio Investigative Site
city: Patra
country: Greece
facility: Adagio Investigative Site
state: Achaïa
city: Athens
country: Greece
facility: Adagio Investigative Site
state: Attiki
city: Athens
country: Greece
facility: Adagio Investigative Site
state: Attiki
city: Athens
country: Greece
facility: Adagio Investigative Site
state: Attiki
city: Athens
country: Greece
facility: Adagio Investigative Site
state: Attiki
city: Heraklion
country: Greece
facility: Adagio Investigative Site
state: Crete
city: Ioánnina
country: Greece
facility: Adagio Investigative Site
city: Níkaia
country: Greece
facility: Adagio Investigative Site
city: Szeged
country: Hungary
facility: Adagio Investigative Site
state: Csongrád
city: Székesfehérvár
country: Hungary
facility: Adagio Investigative Site
state: Fejér
city: Debrecen
country: Hungary
facility: Adagio Investigative Site
state: Hajdú-Bihar
city: Chisinau
country: Moldova, Republic of
facility: Adagio Investigative Site
city: Wroclaw
country: Poland
facility: Adagio Investigative Site
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Adagio Investigative Site
state: Dolnoslaskie
city: Lódz
country: Poland
facility: Adagio Investigative Site
state: Lódzkie
city: Skierniewice
country: Poland
facility: Adagio Investigative Site
state: Lódzkie
city: Kraków
country: Poland
facility: Adagio Investigative Site
state: Malopolskie
city: Bucharest
country: Romania
facility: Adagio Investigative Site
state: Bucuresti
city: Welkom
country: South Africa
facility: Adagio Investigative Site
state: Free State
city: Johannesburg
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Kempton Park
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Tembisa
country: South Africa
facility: Adagio Investigative Site
state: Gauteng
city: Rustenburg
country: South Africa
facility: Adagio Investigative Site
state: North - West
city: Three Rivers
country: South Africa
facility: Adagio Investigative Site
state: Vereeniging
city: Cape Town
country: South Africa
facility: Adagio Investigative Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Adagio Investigative Site
state: Western Cape
city: George
country: South Africa
facility: Adagio Investigative Site
state: Western Cape
city: Somerset West
country: South Africa
facility: Adagio Investigative Site
state: Western Cape
city: Worcester
country: South Africa
facility: Adagio Investigative Site
state: Western Cape
city: George
country: South Africa
facility: Adagio Investigative Site
city: Pretoria
country: South Africa
facility: Adagio Investigative Site
city: Dnipro
country: Ukraine
facility: Adagio Investigative Site
state: Dnipropetrovs'ka Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Adagio Investigative Site
state: Ivano-Frankivs'ka Oblast
city: Kherson
country: Ukraine
facility: Adagio Investigative Site
state: Khersons'ka Oblast
city: Kharkiv
country: Ukraine
facility: Adagio Investigative Site
city: Kyiv
country: Ukraine
facility: Adagio Investigative Site
city: Kyiv
country: Ukraine
facility: Adagio Investigative Site
city: Kyiv
country: Ukraine
facility: Adagio Investigative Site
city: Kyïv
country: Ukraine
facility: Adagio Investigative Site
city: Kyïv
country: Ukraine
facility: Adagio Investigative Site
Study officials:
References:
citation: 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.