Clinical trial NCT04454398: Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
Official title: A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19

Detailed description: This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.

Eligibility criteria: Inclusion Criteria:

* Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
* Willing and able to comply with study procedures and follow-up visits
* 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. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.

Exclusion Criteria:

* Clinical signs indicative of severe COVID-19
* Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
* Documented infection other than COVID-19
* Any medical condition that, in the Investigator's opinion, could adversely impact safety
* Pregnant or lactating women
* 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: Participants 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 (safety)
timeFrame: Randomization through study completion through Day 60
measure: Incidence of treatment-emergent adverse events (safety)
timeFrame: Randomization through study completion through Day 60
measure: Incidence of serious adverse events (safety)
timeFrame: Randomization through study completion through Day 60
measure: All-cause mortality at 29 and 60 days
timeFrame: Randomization through Day 29 and Day 60
measure: Incidence of dose-limiting toxicities (safety)
timeFrame: Randomization through study completion through Day 60
measure: Incidence of laboratory abnormalities (safety)
timeFrame: Randomization through study completion through Day 60
measure: SARS-CoV-2 viral load as assessed using various sample types
timeFrame: Randomization through study completion through Day 60
measure: Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
timeFrame: Randomization up to study completion through Day 60
measure: Anti-drug antibodies
timeFrame: Randomization through study completion through Day 60
measure: Cytokine levels
timeFrame: Randomization through study completion through Day 60
Secondary outcomes:
measure: AUC of COVI-GUARD (PK)
timeFrame: Randomization through study completion through Day 60
measure: Cmax of COVI-GUARD (PK)
timeFrame: Randomization through study completion through Day 60
measure: t½ of COVI-GUARD (PK)
timeFrame: Randomization through study completion through Day 60
measure: Tmax of COVI-GUARD (PK)
timeFrame: Randomization through study completion through 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.