A Phase 2 interventional study of COVI-AMG and Placebo in Covid19, sponsored by Sorrento Therapeutics, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Sorrento Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →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.
Exclusion Criteria:
A single injection of 100 mg of COVI-AMG will be administered.
Biological: COVI-AMG
A single injection of 200 mg of COVI-AMG will be administered.
Biological: COVI-AMG
A single injection of placebo will be administered.
Drug: Placebo
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Also known as: STI-2020
Diluent solution
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
Time frame: Baseline through Day 29
Viral load reduction
Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test
Time frame: Baseline to Day 4, 15, and 29
Time to sustained clinical improvement
Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29
Time frame: Baseline through Day 29
Proportion of subjects with clinical improvement
Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29
Time frame: Baseline to Day 15 and 29
All-cause mortality at Day 29
All-cause mortality at Day 29
Time frame: Baseline through Day 29
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Sorrento Therapeutics, Inc.