Covid-19Phase 1NCT04454398
Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
A Phase 1 study testing COVI-GUARD in people with Covid-19, run by Sorrento Therapeutics, Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- COVI-GUARD
- 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
- Sep 2020to Jan 2021
- Phase
- Phase 1
- 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
- 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.
Who cannot join
- 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.
About this study
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
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
Read the 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.
- Conditions
- Covid-19
- Being tested
- COVI-GUARD, Standard of Care, Placebo
- 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-GUARDBiological
Also called STI-1499
COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
Standard of CareOther
Standard of Care as determined by the Investigator
PlaceboDrug
Diluent
| Study group | Role | What they receive |
|---|---|---|
| COVI-GUARD | Experimental | COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care Receives: Biological: COVI-GUARD; Other: Standard of Care |
| Placebo | Placebo comparator | Placebo administered via a single IV push injection, in addition to standard of care Receives: Other: Standard of Care; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
Measured: Randomization through study completion through Day 60
Incidence of treatment-emergent adverse events (safety)
Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
Measured: Randomization through study completion through Day 60
Incidence of serious adverse events (safety)
Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
Measured: Randomization through study completion through Day 60
All-cause mortality at 29 and 60 days
All-cause mortality at 29 and 60 days
Measured: Randomization through Day 29 and Day 60
Incidence of dose-limiting toxicities (safety)
Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
Measured: Randomization through study completion through Day 60
Incidence of laboratory abnormalities (safety)
Clinically meaningful laboratory abnormalities
Measured: Randomization through study completion through Day 60
SARS-CoV-2 viral load as assessed using various sample types
Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
Measured: Randomization through study completion through Day 60
Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
Measured: Randomization up to study completion through Day 60
Anti-drug antibodies
Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
Measured: Randomization through study completion through Day 60
Cytokine levels
Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
Measured: Randomization through study completion through Day 60
Secondary outcomes (4)
AUC of COVI-GUARD (PK)
Area under the serum concentration-time curve (AUC) of COVI-GUARD
Measured: Randomization through study completion through Day 60
Cmax of COVI-GUARD (PK)
Maximum observed serum concentration (Cmax) of COVI-GUARD
Measured: Randomization through study completion through Day 60
t½ of COVI-GUARD (PK)
Apparent serum terminal elimination half life (t½) of COVI-GUARD
Measured: Randomization through study completion through Day 60
Tmax of COVI-GUARD (PK)
Time to Cmax (Tmax) of COVI-GUARD
Measured: Randomization through study completion through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454398
- Sponsor's protocol ID
- GRD-COV-101
- Status last verified
- Jan 2021
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04454398
- Acronym / sponsor ID
- GRD-COV-101
- Conditions
- Covid-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVI-GUARD | Experimental | Biological: COVI-GUARD, Other: Standard of CareCOVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care |
| Placebo | Placebo comparator | Other: Standard of Care, Drug: PlaceboPlacebo administered via a single IV push injection, in addition to standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVI-GUARDAlso: STI-1499COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein | Biological | COVI-GUARD |
| Standard of CareStandard of Care as determined by the Investigator | Other | COVI-GUARD, Placebo |
| PlaceboDiluent | Drug | Placebo |
Primary outcome
Incidence of adverse events (safety)
Time frame: Randomization through study completion through Day 60
Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
Incidence of treatment-emergent adverse events (safety)
Time frame: Randomization through study completion through Day 60
Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
Incidence of serious adverse events (safety)
Time frame: Randomization through study completion through Day 60
Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
All-cause mortality at 29 and 60 days
Time frame: Randomization through Day 29 and Day 60
All-cause mortality at 29 and 60 days
Incidence of dose-limiting toxicities (safety)
Time frame: Randomization through study completion through Day 60
Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
Incidence of laboratory abnormalities (safety)
Time frame: Randomization through study completion through Day 60
Clinically meaningful laboratory abnormalities
SARS-CoV-2 viral load as assessed using various sample types
Time frame: Randomization through study completion through Day 60
Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
Time frame: Randomization up to study completion through Day 60
Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
Anti-drug antibodies
Time frame: Randomization through study completion through Day 60
Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
Cytokine levels
Time frame: Randomization through study completion through Day 60
Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
4 secondary outcomes
AUC of COVI-GUARD (PK)
Time frame: Randomization through study completion through Day 60
Cmax of COVI-GUARD (PK)
Time frame: Randomization through study completion through Day 60
t½ of COVI-GUARD (PK)
Time frame: Randomization through study completion through Day 60
Tmax of COVI-GUARD (PK)
Time frame: Randomization through study completion through Day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 34473343Kreuzberger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVI-GUARD in people with Covid-19, 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 3 inclusion and 6 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 8 Jan 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 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.
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 (safety) (time frame: Randomization through study completion through Day 60). The study lists 10 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 NCT04454398, 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 8 Jan 2021.