Covid19Phase 2NCT04906694
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
A Phase 2 study testing COVI-DROPS in people with Covid19, run by Sorrento Therapeutics, Inc. at 18 sites in United States.
Trial summary
This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Covid19
- What is being tested?
- COVI-DROPS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 18 sitesUnited States
- Study dates
- 16 Nov 2021to 13 Jan 2022
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
- Either have no COVID-19 symptoms (asymptomatic) or mild symptoms
- 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 must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
- Willing to follow contraception guidelines
Who cannot join
- In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
- Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process.
- Has a documented infection other than COVID-19
- Pregnant or lactating women who are breast feeding or planning on either during the study
- 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 a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html)
- Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
WR-ClinSearch
Chattanooga, Tennessee, 37421
Future Innovative Treatments, LLC
Colorado Springs, Colorado, 80907
Remington Davis
Columbus, Ohio, 43215
Revival Research Institute
Dearborn, Michigan, 48126
Advanced Medical Trials
Georgetown, Texas, 78628
Precision Comprehensive Clinical Research Solutions
Grapevine, Texas, 76051
Cyn3rgy Research
Gresham, Oregon, 97030
Centex Studies Inc. Houston
Houston, Texas, 77062
Clinical Neuroscience dba CNS Healthcare
Jacksonville, Florida, 32256
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501
Med-Care Research
Miami, Florida, 33165
Quality Clinical Research
Omaha, Nebraska, 68114
Clinical Neuroscience Solutions Healthcare
Orlando, Florida, 32801
Randomize Now
Peachtree City, Georgia, 30269
LinQ
Pearland, Texas, 77584
Epic Research
Red Oak, Texas, 75154
Precision Research Center
Tampa, Florida, 33614
Clinical Site Partners, Inc
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Read the detailed description
Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.
- Conditions
- Covid19
- Being tested
- COVI-DROPS, 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-DROPSBiological
Also called STI-2099
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
PlaceboDrug
Diluent solution
| Study group | Role | What they receive |
|---|---|---|
| COVI-DROPS | Experimental | 10, 20, or 40 mg of COVI-DROPS administered intranasally Receives: Biological: COVI-DROPS |
| Placebo | Placebo comparator | 2 mL administered intranasally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who have COVID-19-related visit or hospitalization
Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)
Measured: Baseline through Day 29
Secondary outcomes (4)
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Measured: Baseline through Day 29
Viral load change from baseline to D8
Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
Measured: Baseline to Day 8
Change in WHO Clinical Progression Scale score
Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Measured: Baseline to Day 8 and Day 29
Viral load change from baseline to D29
Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL)
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start16 Nov 2021
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 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
- NCT04906694
- Sponsor's protocol ID
- DRP-COV-201US
- Status last verified
- Jan 2022
- First submitted
- 26 May 2021
- Last updated
- 3 Feb 2022
- 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 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04906694
- Acronym / sponsor ID
- DRP-COV-201US
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 28 May 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 double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Detailed description
Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.
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 |
|---|---|---|
| COVI-DROPS | Experimental | Biological: COVI-DROPS10, 20, or 40 mg of COVI-DROPS administered intranasally |
| Placebo | Placebo comparator | Drug: Placebo2 mL administered intranasally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
- Either have no COVID-19 symptoms (asymptomatic) or mild symptoms
- 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 must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
- Willing to follow contraception guidelines
Key exclusion criteria (7 listed)
- In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
- Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process.
- Has a documented infection other than COVID-19
- Pregnant or lactating women who are breast feeding or planning on either during the study
- 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-DROPSAlso: STI-2099COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2 | Biological | COVI-DROPS |
| PlaceboDiluent solution | Drug | Placebo |
Primary outcome
Proportion of subjects who have COVID-19-related visit or hospitalization
Time frame: Baseline through Day 29
Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)
4 secondary outcomes
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time frame: Baseline through Day 29
Viral load change from baseline to D8
Time frame: Baseline to Day 8
Change in WHO Clinical Progression Scale score
Time frame: Baseline to Day 8 and Day 29
Viral load change from baseline to D29
Time frame: Baseline to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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, Inc.
18 sites 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-DROPS in people with Covid19, run by Sorrento Therapeutics, Inc. at 18 sites 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 have COVID-19-related visit or hospitalization (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?
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 3 Feb 2022.