NCT04771351

Brief Summary

This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

February 23, 2021

Last Update Submit

August 15, 2022

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who are alive and free of respiratory failure at Day 29

    Proportion of subjects who are alive and free of respiratory failure at Day 29

    Baseline through Day 29

Secondary Outcomes (4)

  • Viral load reduction

    Baseline to Day 4, 15, and 29

  • Time to sustained clinical improvement

    Baseline through Day 29

  • Proportion of subjects with clinical improvement

    Baseline to Day 15 and 29

  • All-cause mortality at Day 29

    Baseline through Day 29

Study Arms (3)

COVI-AMG 100 mg

EXPERIMENTAL

A single injection of 100 mg of COVI-AMG will be administered.

Biological: COVI-AMG

COVI-AMG 200 mg

EXPERIMENTAL

A single injection of 200 mg of COVI-AMG will be administered.

Biological: COVI-AMG

Placebo

PLACEBO COMPARATOR

A single injection of placebo will be administered.

Drug: Placebo

Interventions

COVI-AMGBIOLOGICAL

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

Also known as: STI-2020
COVI-AMG 100 mgCOVI-AMG 200 mg
PlaceboDRUG

Diluent solution

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive for COVID-19 by an approved antigen test
  • Progressive disease suggestive of ongoing COVID-19 infection
  • Requires hospitalization for acute medical care
  • Provides written informed consent
  • Willing to follow contraception guidelines during study

You may not qualify if:

  • Requires high-flow oxygen supplementation
  • Current or imminent respiratory failure
  • Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
  • Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
  • Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
  • Pregnant or lactating and breast feeding, or planning on either during the study
  • Unable to comply with planned study procedures and be available for all follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

Related Publications (1)

  • 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.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

STI-2020

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mike Royal, MD

    Sorrento Therapeutics

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 25, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

US(1)