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Covid19Phase 1/2NCT04584697

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

A Phase 1/2 study testing COVI-AMG in people with Covid19, run by Sorrento Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
COVI-AMG
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2020to Apr 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.

Read the 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.

Conditions
Covid19
Being tested
COVI-AMG, Placebo
Keywords
covid-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVI-AMGBiological

    Also called STI-2020

    COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb).

  • PlaceboDrug

    Diluent solution

Study groups in NCT04584697
Study groupRoleWhat they receive
COVI-AMGExperimentalA 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.
Receives: Biological: COVI-AMG
PlaceboPlacebo comparatorA single injection of placebo will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events by type, frequency, severity, and causality (safety)

    Safety as assessed by incidence of adverse events by type, frequency, severity, and causality

    Measured: Randomization through study completion at Day 60

  2. Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)

    Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality

    Measured: Randomization through study completion at Day 60

  3. Incidence of serious adverse events by type, frequency, severity, and causality (safety)

    Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality

    Measured: Randomization through study completion at Day 60

  4. Incidence of dose-limiting toxicities (safety)

    Safety as assessed by incidence of dose-limiting toxicities

    Measured: Randomization through study completion at Day 60

  5. Incidence of clinically meaningful laboratory abnormalities (safety)

    Safety as assessed by incidence of clinically meaningful laboratory abnormalities

    Measured: Randomization through study completion at Day 60

  6. Viral load as assessed using plasma and salivary samples at various timepoints

    Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing

    Measured: Randomization through study completion at Day 60

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

    Time from onset of COVID-19 symptoms to treatment (Day 1)

    Measured: Day 1

  8. Presence and levels of anti-drug antibodies directed to COVI-AMG

    Presence and levels of anti-drug antibodies directed to COVI-AMG

    Measured: Randomization through study completion at Day 60

  9. Cytokine levels post-treatment

    Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA

    Measured: Randomization through study completion at Day 60

Secondary outcomes (4)

  1. AUC of COVI-AMG (PK)

    Area under the serum concentration-time curve (AUC) of COVI-AMG

    Measured: Randomization through study completion at Day 60

  2. Cmax of COVI-AMG (PK)

    Maximum observed serum concentration (Cmax) of COVI-AMG

    Measured: Randomization through study completion at Day 60

  3. Tmax of COVI-AMG (PK)

    Time to Cmax (Tmax) of COVI-AMG

    Measured: Randomization through study completion at Day 60

  4. t½ of COVI-AMG (PK)

    Apparent serum terminal elimination half life (t½) of COVI-AMG

    Measured: Randomization through study completion at Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Why it stopped: Different study will be conducted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584697
Sponsor's protocol ID
AMG-COV-102
Status last verified
Feb 2021
First submitted
7 Oct 2020
Last updated
12 Feb 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing COVI-AMG in people with Covid19, run by Sorrento Therapeutics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events by type, frequency, severity, and causality (safety) (time frame: Randomization through study completion at Day 60). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.

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