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WithdrawnNCT04738175Updated Feb 25, 2022

Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

A Phase 1/2 interventional study of COVI-AMG and Placebo in Covid19, sponsored by Sorrento Therapeutics, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by Sorrento Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
A different study will be conducted.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Read the detailed description

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

02

Conditions studied

  • Covid19

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Keywords

  • covid-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

Sorrento Therapeutics, Inc. is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
  • No medical or psychiatric conditions that could put the subject at risk
  • Willing to follow contraception guidelines

Exclusion criteria

Exclusion Criteria:

  • Clinical signs of COVID-19 indicative of impending hospitalization
  • Documented infection in addition to COVID-19 that requires systemic treatment
  • Medical condition that could adversely impact safety, in the Investigator's opinion
  • Is or planning to be pregnant or lactating
  • Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
  • Has received or will receive during study participation a vaccine for COVID-19
  • Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    COVI-AMG

    40 mg, 100 mg, or 200 mg of COVI-AMG will be administered

    Biological: COVI-AMG

  • Placebo comparator
    Placebo

    Placebo will be administered

    Drug: Placebo

Interventions

  • BiologicalCOVI-AMG

    COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)

    Also known as: STI-2020

  • DrugPlacebo

    Diluent solution

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events by type, frequency, severity, and causality (safety)

    Safety as assessed by incidence of adverse events by type, frequency, severity, and causality

    Time frame: Randomization through study completion at Day 70

  2. Changes in viral shedding from Baseline to Day 15

    Changes in viral shedding from Baseline to Day 15

    Time frame: Randomization to Day 15

Secondary outcomes

  1. Changes in viral shedding from Baseline to Day 8, 29, 43, and 70

    Changes in viral shedding from Baseline to Day 8, 29, 43, and 70

    Time frame: Randomization to Day 8, 29, 43, 70

  2. Time to viral RNA negativity

    Time to viral RNA negativity using nasopharyngeal reverse transcription PCR

    Time frame: Randomization through study completion at Day 70

  3. Time to resolution of symptoms

    Time to resolution of symptoms as assessed by the COVID-19 PRO instrument

    Time frame: Randomization through study completion at Day 70

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04738175
Lead sponsor
Sorrento Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 4, 2021
Start date
Apr 2021 (estimated)
Primary completion
Nov 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Feb 25, 2022

Study contacts

Mike Royal, MD
study director · Sorrento Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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