Covid19Phase 1/2NCT04738175
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
A Phase 1/2 study testing COVI-AMG in people with Covid19, run by Sorrento Therapeutics, Inc..
Trial summary
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Nov 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
- Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
- No medical or psychiatric conditions that could put the subject at risk
- Willing to follow contraception guidelines
Who cannot join
- Clinical signs of COVID-19 indicative of impending hospitalization
- Documented infection in addition to COVID-19 that requires systemic treatment
- Medical condition that could adversely impact safety, in the Investigator's opinion
- Is or planning to be pregnant or lactating
- 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
- Has received or will receive during study participation a vaccine for COVID-19
- Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Read the detailed description
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 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 group | Role | What they receive |
|---|---|---|
| COVI-AMG | Experimental | 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered Receives: Biological: COVI-AMG |
| Placebo | Placebo comparator | Placebo will be administered Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 70
Changes in viral shedding from Baseline to Day 15
Changes in viral shedding from Baseline to Day 15
Measured: Randomization to Day 15
Secondary outcomes (3)
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Measured: Randomization to Day 8, 29, 43, 70
Time to viral RNA negativity
Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
Measured: Randomization through study completion at Day 70
Time to resolution of symptoms
Time to resolution of symptoms as assessed by the COVID-19 PRO instrument
Measured: Randomization through study completion at Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startApr 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: A different study will be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, 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
- NCT04738175
- Sponsor's protocol ID
- AMG-COV-201-BR
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
- ClinicalTrials.gov ID
- NCT04738175
- Acronym / sponsor ID
- AMG-COV-201-BR
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A different study will be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 4 Feb 2021 (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.
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Detailed description
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVI-AMG | Experimental | Biological: COVI-AMG40 mg, 100 mg, or 200 mg of COVI-AMG will be administered |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
- No medical or psychiatric conditions that could put the subject at risk
- Willing to follow contraception guidelines
Key exclusion criteria (7 listed)
- Clinical signs of COVID-19 indicative of impending hospitalization
- Documented infection in addition to COVID-19 that requires systemic treatment
- Medical condition that could adversely impact safety, in the Investigator's opinion
- Is or planning to be pregnant or lactating
- 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
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-AMGAlso: STI-2020COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb) | Biological | COVI-AMG |
| PlaceboDiluent solution | Drug | Placebo |
Primary outcome
Incidence of adverse events by type, frequency, severity, and causality (safety)
Time frame: Randomization through study completion at Day 70
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Changes in viral shedding from Baseline to Day 15
Time frame: Randomization to Day 15
Changes in viral shedding from Baseline to Day 15
3 secondary outcomes
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Time frame: Randomization to Day 8, 29, 43, 70
Time to viral RNA negativity
Time frame: Randomization through study completion at Day 70
Time to resolution of symptoms
Time frame: Randomization through study completion at Day 70
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 25 Feb 2022.
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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 1/2 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 3 inclusion and 7 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 25 Feb 2022. 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 70). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.