Trials / Withdrawn
WithdrawnNCT04584697
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19
A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Who Are Asymptomatic or Have Mild Symptoms
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sorrento Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 days after dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | COVI-AMG | COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb). |
| DRUG | Placebo | Diluent solution |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2020-10-14
- Last updated
- 2021-02-12
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04584697. Inclusion in this directory is not an endorsement.