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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04805671 |
|
Full text link
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 26, 2022, 10:48 a.m. Source : ClinicalTrials.gov |
ClinicalTrials@adagiotx.com |
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Registration date
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-03-18 |
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Recruitment status
Last imported at : Dec. 1, 2022, 4 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Aug. 24, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
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
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- 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 |
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Number of arms
Last imported at : May 26, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Sept. 26, 2022, 5 a.m. Source : ClinicalTrials.gov |
Invivyd, Inc. |
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Inclusion age min
Last imported at : Aug. 24, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
12 |
|
Inclusion age max
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Jan. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
Argentina;Brazil;Bulgaria;Germany;Greece;Hungary;Republic of Moldova;Poland;Romania;South Africa;Ukraine |
|
Type of patients
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Feb. 8, 2024, 4 a.m. Source : ClinicalTrials.gov |
399 |
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primary outcome
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation);Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure);Incidence of COVID-19 related hospitalizations or all-cause death;Incidence of solicited injection site reactions;Incidence of treatment-emergent adverse events |
|
Notes
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : May 26, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "1;IM", "treatment_id": 31, "treatment_name": "Adg20", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |