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Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19

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ClinicalTrials.gov Identifier: NCT04584697
Recruitment Status : Withdrawn (Different study will be conducted)
First Posted : October 14, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: COVI-AMG Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: COVI-AMG
A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.
Biological: COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb).
Other Name: STI-2020

Placebo Comparator: Placebo
A single injection of placebo will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.
Drug: Placebo
Diluent solution




Primary Outcome Measures :
  1. Incidence of adverse events by type, frequency, severity, and causality (safety) [ Time Frame: Randomization through study completion at Day 60 ]
    Safety as assessed by incidence of adverse events by type, frequency, severity, and causality

  2. Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety) [ Time Frame: Randomization through study completion at Day 60 ]
    Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality

  3. Incidence of serious adverse events by type, frequency, severity, and causality (safety) [ Time Frame: Randomization through study completion at Day 60 ]
    Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality

  4. Incidence of dose-limiting toxicities (safety) [ Time Frame: Randomization through study completion at Day 60 ]
    Safety as assessed by incidence of dose-limiting toxicities

  5. Incidence of clinically meaningful laboratory abnormalities (safety) [ Time Frame: Randomization through study completion at Day 60 ]
    Safety as assessed by incidence of clinically meaningful laboratory abnormalities

  6. Viral load as assessed using plasma and salivary samples at various timepoints [ Time Frame: Randomization through study completion at Day 60 ]
    Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing

  7. Time from onset of COVID-19 symptoms to treatment (Day 1) [ Time Frame: Day 1 ]
    Time from onset of COVID-19 symptoms to treatment (Day 1)

  8. Presence and levels of anti-drug antibodies directed to COVI-AMG [ Time Frame: Randomization through study completion at Day 60 ]
    Presence and levels of anti-drug antibodies directed to COVI-AMG

  9. Cytokine levels post-treatment [ Time Frame: Randomization through study completion at Day 60 ]
    Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA


Secondary Outcome Measures :
  1. AUC of COVI-AMG (PK) [ Time Frame: Randomization through study completion at Day 60 ]
    Area under the serum concentration-time curve (AUC) of COVI-AMG

  2. Cmax of COVI-AMG (PK) [ Time Frame: Randomization through study completion at Day 60 ]
    Maximum observed serum concentration (Cmax) of COVI-AMG

  3. Tmax of COVI-AMG (PK) [ Time Frame: Randomization through study completion at Day 60 ]
    Time to Cmax (Tmax) of COVI-AMG

  4. t½ of COVI-AMG (PK) [ Time Frame: Randomization through study completion at Day 60 ]
    Apparent serum terminal elimination half life (t½) of COVI-AMG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584697


Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04584697    
Other Study ID Numbers: AMG-COV-102
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sorrento Therapeutics, Inc.:
covid-19