Clinical trial NCT04584697: Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Initially, 2 subjects will be enrolled at the 40 mg dose level. If no safety concerns arise, 48 subjects will then be randomized 1:1:1:1 to receive 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented.
* Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization.
* Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol.
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.

Exclusion Criteria:

* Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study.
* Have any medical condition that, in the Investigator's opinion, could adversely impact safety.
* Be pregnant or lactating and breast feeding
* 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. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.

Primary outcomes:
measure: Incidence of adverse events by type, frequency, severity, and causality (safety)
timeFrame: Randomization through study completion at Day 60
measure: Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)
timeFrame: Randomization through study completion at Day 60
measure: Incidence of serious adverse events by type, frequency, severity, and causality (safety)
timeFrame: Randomization through study completion at Day 60
measure: Incidence of dose-limiting toxicities (safety)
timeFrame: Randomization through study completion at Day 60
measure: Incidence of clinically meaningful laboratory abnormalities (safety)
timeFrame: Randomization through study completion at Day 60
measure: Viral load as assessed using plasma and salivary samples at various timepoints
timeFrame: Randomization through study completion at Day 60
measure: Time from onset of COVID-19 symptoms to treatment (Day 1)
timeFrame: Day 1
measure: Presence and levels of anti-drug antibodies directed to COVI-AMG
timeFrame: Randomization through study completion at Day 60
measure: Cytokine levels post-treatment
timeFrame: Randomization through study completion at Day 60
Secondary outcomes:
measure: AUC of COVI-AMG (PK)
timeFrame: Randomization through study completion at Day 60
measure: Cmax of COVI-AMG (PK)
timeFrame: Randomization through study completion at Day 60
measure: Tmax of COVI-AMG (PK)
timeFrame: Randomization through study completion at Day 60
measure: t½ of COVI-AMG (PK)
timeFrame: Randomization through study completion at Day 60
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
citation: 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.