Covid19Phase 2NCT04771351
Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19
A Phase 2 study testing COVI-AMG in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults 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
- 1 siteUnited States
- Study dates
- Apr 2021to Oct 2021
- Phase
- Phase 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
- Positive for COVID-19 by an approved antigen test
- Progressive disease suggestive of ongoing COVID-19 infection
- Requires hospitalization for acute medical care
- Provides written informed consent
- Willing to follow contraception guidelines during study
Who cannot join
- Requires high-flow oxygen supplementation
- Current or imminent respiratory failure
- Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
- Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
- Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
- Pregnant or lactating and breast feeding, or planning on either during the study
- Unable to comply with planned study procedures and be available for all follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post 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 100 mg | Experimental | A single injection of 100 mg of COVI-AMG will be administered. Receives: Biological: COVI-AMG |
| COVI-AMG 200 mg | Experimental | A single injection of 200 mg of COVI-AMG will be administered. Receives: Biological: COVI-AMG |
| Placebo | Placebo comparator | A single injection of placebo will be administered. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are alive and free of respiratory failure at Day 29
Proportion of subjects who are alive and free of respiratory failure at Day 29
Measured: Baseline through Day 29
Secondary outcomes (4)
Viral load reduction
Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test
Measured: Baseline to Day 4, 15, and 29
Time to sustained clinical improvement
Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29
Measured: Baseline through Day 29
Proportion of subjects with clinical improvement
Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29
Measured: Baseline to Day 15 and 29
All-cause mortality at Day 29
All-cause mortality at Day 29
Measured: Baseline through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study startApr 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- 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
- NCT04771351
- Sponsor's protocol ID
- AMG-COV-202
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2021
- Last updated
- 16 Aug 2022
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04771351
- Acronym / sponsor ID
- AMG-COV-202
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 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
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 25 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.
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVI-AMG 100 mg | Experimental | Biological: COVI-AMGA single injection of 100 mg of COVI-AMG will be administered. |
| COVI-AMG 200 mg | Experimental | Biological: COVI-AMGA single injection of 200 mg of COVI-AMG will be administered. |
| Placebo | Placebo comparator | Drug: PlaceboA single injection of placebo 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 (5 listed)
- Positive for COVID-19 by an approved antigen test
- Progressive disease suggestive of ongoing COVID-19 infection
- Requires hospitalization for acute medical care
- Provides written informed consent
- Willing to follow contraception guidelines during study
Key exclusion criteria (7 listed)
- Requires high-flow oxygen supplementation
- Current or imminent respiratory failure
- Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
- Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
- Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
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 100 mg, COVI-AMG 200 mg |
| PlaceboDiluent solution | Drug | Placebo |
Primary outcome
Proportion of subjects who are alive and free of respiratory failure at Day 29
Time frame: Baseline through Day 29
Proportion of subjects who are alive and free of respiratory failure at Day 29
4 secondary outcomes
Viral load reduction
Time frame: Baseline to Day 4, 15, and 29
Time to sustained clinical improvement
Time frame: Baseline through Day 29
Proportion of subjects with clinical improvement
Time frame: Baseline to Day 15 and 29
All-cause mortality at Day 29
Time frame: Baseline through Day 29
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 16 Aug 2022.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVI-AMG in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in United States.
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 5 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Proportion of subjects who are alive and free of respiratory failure at Day 29 (time frame: Baseline through Day 29). 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 NCT04771351, 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 16 Aug 2022.