Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
NCT05142527 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2023-02-03
Summary
This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).
Conditions
Interventions
- DRUG
-
ADM03820
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Enabling Biotechnologies (EB)
collaborator UNKNOWN -
Alachua Government Services, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2024-01-31
- Completion
- 2024-04-30
- FDA Drug
- Yes
More Related Trials
-
A Study of Ad26.COV2.S in Adults (COVID-19)
NCT04436276 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
NCT04652102 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
NCT04352608 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
NCT04452318 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
NCT01390025 ·Status: COMPLETED ·Phase: PHASE1
-
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine
NCT05652543 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of S-268019 for the Prevention of COVID-19
NCT05212948 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
NCT04655625 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects
NCT05977101 ·Status: UNKNOWN ·Phase: NA
-
An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older
NCT05679466 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
NCT04679909 ·Status: COMPLETED ·Phase: PHASE1
-
The Safety and Tolerability of A8G6 COVID-19 Neutralization Antibody Combined With Nasal Spray
NCT06127498 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19
NCT05817045 ·Status: COMPLETED ·Phase: NA
-
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
NCT04313127 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I/II Study to Evaluate a SARS-CoV-2 mRNA Vaccine in Healthy Adults
NCT05903118 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
NCT04591717 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of NVX-CoV2705
NCT07086222 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study of Ad26.COV2.S in Adults (COVID-19)
NCT04509947 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19
NCT04813796 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
NCT04412538 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Ad26.COV2.S in Healthy Adults (COVID-19)
NCT04894305 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers
NCT04773067 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19)
NCT07266558 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )
NCT04426201 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
NCT05293678 ·Status: COMPLETED ·Phase: PHASE1