Covid19Phase 2NCT04900428
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)
A Phase 2 study testing COVI-DROPS in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in United Kingdom.
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 years and older
- 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
- 179 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2021to 6 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive for COVID-19 with any locally approved RT-PCR within 7 days of planned treatment.
- Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
- Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
- Subject must have provided written informed consent
- Willing to follow contraception guidelines
Who cannot join
- Moderate or severe illness/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 subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
- Documented acute infection other thand COVID-19
- Pregnant or lactating women who are breast feeding or planning to during the study
- Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Coventry and Warwickshire Hospital Trust
Coventry
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of 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 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). 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 mg or 20 mg of COVI-DROPS administered intranasally Receives: Biological: COVI-DROPS |
| Placebo | Placebo comparator | 1 mL administered intranasally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load change from baseline to D8
Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs
Measured: Baseline to Day 8
Secondary outcomes (6)
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Measured: Baseline through Day 29
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
Change in WHO Clinical Progression Scale score
Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Measured: Baseline to Day 8 and Day 29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 (score of 0-10, with lower score meaning better outcome)
Measured: Baseline through Day 29
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Measured: Baseline to Day 29
Change in patient-reported COVID-19 symptoms
Change in patient-reported COVID-19 symptoms as assessed using the Patient Reported Outcome Instrument for Capture of COVID-19-Related Symptoms (score of 0-50, with lower score meaning better outcome)
Measured: Baseline to Day 8 and 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 May 2021
- Study start16 Jul 2021
- Primary completion22 Mar 2022
- Study completion6 May 2022
Why it stopped: Study was terminated at interim analysis due to drops not working on new variants
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 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
- NCT04900428
- Sponsor's protocol ID
- DRP-COV-201UK
- Status last verified
- Jan 2023
- First submitted
- 20 May 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- 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 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04900428
- Acronym / sponsor ID
- DRP-COV-201UK
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated at interim analysis due to drops not working on new variants
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 25 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 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). 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 mg or 20 mg of COVI-DROPS administered intranasally |
| Placebo | Placebo comparator | Drug: Placebo1 mL administered intranasally |
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 with any locally approved RT-PCR within 7 days of planned treatment.
- Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
- Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
- Subject must have provided written informed consent
- Willing to follow contraception guidelines
Key exclusion criteria (5 listed)
- Moderate or severe illness/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 subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
- Documented acute infection other thand COVID-19
- Pregnant or lactating women who are breast feeding or planning to during the study
- Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, 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
Viral load change from baseline to D8
Time frame: Baseline to Day 8
Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs
6 secondary outcomes
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Time frame: Baseline through Day 29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time frame: Baseline through Day 29
Change in WHO Clinical Progression Scale score
Time frame: Baseline to Day 8 and Day 29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
Time frame: Baseline through Day 29
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Time frame: Baseline to Day 29
Change in patient-reported COVID-19 symptoms
Time frame: Baseline to Day 8 and Day 29
Results and safety
The study was stopped early (reason given: Study was terminated at interim analysis due to drops not working on new variants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- 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, 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 COVI-DROPS in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in United Kingdom.
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 5 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: stopped early, as of the sponsor's last update on 30 Jan 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 Kingdom. 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 stopped early (reason given: Study was terminated at interim analysis due to drops not working on new variants). Results are not available in the source record.
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?
Viral load change from baseline to D8 (time frame: Baseline to Day 8). 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 NCT04900428, 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 30 Jan 2023.