COVID-19Phase 2NCT05372783
Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
A Phase 2 study testing STI-9199 in people with COVID-19, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- STI-9199
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2023to Oct 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting < 5 days prior to screening visits
- Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity
- Willing and able to comply with study procedures and follow-up visits
- Willing to follow all contraception guidelines
Who cannot join
- In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms
- Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study
- Has a prior history of long COVID
- Has a clinically documents acute infection other than COVID-19
- Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
- Has participated, or is participating in a clinical reserach study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or IV immunoglobulin within 2 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.
Read the detailed description
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.
- Conditions
- COVID-19
- Being tested
- STI-9199, 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.
STI-9199Drug
STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
PlaceboDrug
Diluent solution
| Study group | Role | What they receive |
|---|---|---|
| STI-9199 | Experimental | 4 mg, 10 mg or 20 mg STI-9199 administered intranasally Receives: Drug: STI-9199 |
| Placebo | Placebo comparator | Placebo administered intranasally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load
Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Measured: Baseline through Day 8
Incidence of adverse events (AEs) (safety)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Measured: Baseline through study completion at up to 30 days
Secondary outcomes (4)
Change in viral load
Change in viral load from baseline to Day 4, Day 11 and Day 15 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Measured: Baseline through Day 11
Participant perceived disease progression
Participants rate their progression of disease on Day 8 and Day 15 when asked "Have your COVID symptoms gotten worse since treatment?" Yes or No response
Measured: Baseline through Day 15
Rate of COVID-19-related medical visits
Determine the proportion of participants having COVID-19-related medically attended visits, emergency department assessments, hospitalization or all-cause mortality
Measured: Baseline through Day 30
Patient rated response
Proportion of participants scoring ≥ +1 and those scoring ≤ -1 using a patient global impression of change (PGIC) 7-point categorical scale on Day 8 and Day 15 when responding to the question "In terms of your COVID-19 symptoms, how much benefit if any did you receive from the treatment?" The 7-point scale range is -3 to +3 where -3 is "very much worse" to +3 "very much improved" based on how the participant feels post-treatment
Measured: Baseline through D15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study startApr 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Study was never launched
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372783
- Sponsor's protocol ID
- SHLD-COV-201
- Status last verified
- Feb 2023
- First submitted
- 10 May 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of Intranasal STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents
- ClinicalTrials.gov ID
- NCT05372783
- Acronym / sponsor ID
- SHLD-COV-201
- Conditions
- COVID-19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never launched
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 May 2022 (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 Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms.
Detailed description
This is a Phase 2 global, randomized, double-blind, placebo-controlled study designed to investigate the safety and preliminary efficacy of intranasal STI-9199 in adults and adolescents who are COVID-19 positive with mild to moderate symptoms. This is a single dose study and three different dose concentrations will be compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STI-9199 | Experimental | Drug: STI-91994 mg, 10 mg or 20 mg STI-9199 administered intranasally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered intranasally |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Otherwise healthy, positive for COVID-19 by an EUA-approved rapid antigen or PCR test, has ongoing "mild to moderate illness or symptoms" with symptom onset starting < 5 days prior to screening visits
- Must provide written informed consent/assent if a minor which includes signing the institutional review board/independent ethics committee approved consent form prior to participating in any study related activity
- Willing and able to comply with study procedures and follow-up visits
- Willing to follow all contraception guidelines
Key exclusion criteria (6 listed)
- In the Investigator's opinion, has progressive symptoms with likely imminent (24-48 hours) hospitalization or severe COVID-19 illness/symptoms
- Any medical condition that, in the Investigator's or designee's opinion, could adversely impact participant safety or key objectives of the study
- Has a prior history of long COVID
- Has a clinically documents acute infection other than COVID-19
- Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
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 |
|---|---|---|
| STI-9199STI-9199 is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2 | Drug | STI-9199 |
| PlaceboDiluent solution | Drug | Placebo |
Primary outcome
Change in viral load
Time frame: Baseline through Day 8
Change in viral load from baseline to Day 8 based on quantitative reverse-transcription polymerase chain reaction of COVID-19 virus from oropharyngeal swab collection
Incidence of adverse events (AEs) (safety)
Time frame: Baseline through study completion at up to 30 days
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
4 secondary outcomes
Change in viral load
Time frame: Baseline through Day 11
Participant perceived disease progression
Time frame: Baseline through Day 15
Rate of COVID-19-related medical visits
Time frame: Baseline through Day 30
Patient rated response
Time frame: Baseline through D15
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 13 Feb 2023.
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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, Inc.
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 STI-9199 in people with COVID-19, 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 4 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 13 Feb 2023. 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?
Change in viral load (time frame: Baseline through Day 8). 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 13 Feb 2023.