NCT04734860

Brief Summary

This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

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

Geographic Reach
1 country

4 active sites

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withdrawn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

January 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 29, 2021

Last Update Submit

February 9, 2022

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who have remained out of the hospital or emergency room through Day 29

    Proportion of subjects who have remained out of the hospital or emergency room through Day 29

    Randomization to Day 29

Secondary Outcomes (4)

  • Viral load reduction from baseline to Day 8, 15, 29, 43, and 70

    Randomization to Day 8, 15, 29, 43, 70

  • Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70

    Randomization to Day 43 and Day 70

  • Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score

    Randomization to Day 15, 29, 43

  • Time to resolution of fever

    Randomization through study completion at Day 70

Study Arms (2)

COVI-AMG

EXPERIMENTAL

A single injection of 40 mg, 100 mg, or 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
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
  • Mild symptoms consistent with a COVID-19 viral infection
  • Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
  • Willing to follow contraception guidelines

You may not qualify if:

  • Evidence of moderate COVID-19 per FDA severity categorization
  • Pregnant or lactating and breast feeding or planning on either during the study
  • Has a documented infection other than COVID-19
  • Has received a COVID-19 vaccine
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Collaborative NeuroScience Research, LLC

Garden Grove, California, 92845, United States

Location

Synergy Healthcare LLC

Bradenton, Florida, 34208, United States

Location

Med-Care Research

Miami, Florida, 33165, United States

Location

ETNA Medical Center

Tamarac, Florida, 33321, 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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 2, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

US(4)