SARS CoV 2 InfectionPhase 1NCT05135624
SP16 as a Therapeutic for COVID-19 Induced ARDS
A Phase 1 study testing SP16 (6mg) and SP16 (12 mg) in people with SARS CoV 2 Infection and Pneumonia, run by Serpin Pharma, LLC at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection, Pneumonia
- What is being tested?
- SP16 (6mg) and SP16 (12 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 30 Jun 2023
- Phase
- Phase 1
- 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
- To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:
- Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive
- PCR test result and can provide informed consent
- Diagnosed with pneumonia due to SARS-CoV-2
- Respiratory rate ≥ 25/minute and SpO2 ≤ 93%
- Review of Chest radiograph, chest computed tomography (CT) scan, or chest ultrasound consistent with bilateral infiltrates.
- Horowitz index (partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]) ≤ 300. If a subject does not have an arterial line in place, a SpO2/FiO2 ≤ 315 may be used.
Who cannot join
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Age < 18
- Pregnant or lactating women
- History of heart failure
- Clinically significant cardiac dysrhythmia, as determined by investigator
- History renal impairment
- Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.
Read the detailed description
SARS-CoV-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. SP16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. SP16's mechanism of action is through targeting LRP1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. The main objective of this study is to determine the safety and tolerability, and effects on inflammation of SP16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). SP16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. The study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the Intensive Care Unit (ICU).
- Conditions
- SARS CoV 2 Infection, Pneumonia
- Being tested
- SP16 (6mg), Placebo, SP16 (12 mg)
- Keywords
- Pneumonia due to SARS-CoV-2
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP16 (6mg)Drug
SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16
PlaceboOther
Placebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water
SP16 (12 mg)Drug
SP16 will be administered as a single 2 mL s.c. injection of 3 mg/mL SP16 and 1 concurrent separate 2 mL s.c. injection of sterile water
| Study group | Role | What they receive |
|---|---|---|
| Cohort dose 1 of SP16 | Experimental | Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection Receives: Drug: SP16 (6mg) |
| Cohort dose 2 of SP16 | Experimental | Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection Receives: Drug: SP16 (12 mg) |
| Placebo | Placebo comparator | Patients in placebo arm will receive sterile water by subcutaneous injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)
Measured: Day 1 to 14
Change in inflammatory cytokines
Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)
Measured: Day 3, Day 6, and Day 14
Change in acute phase reactants
Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)
Measured: Day 3, Day 6, and Day 14
Secondary outcomes (9)
Proportion of subjects requiring ventilation
The proportion of subjects in each dose group who required intubation and noninvasive ventilation by Day 14
Measured: Day 14
Improvement from baseline in SpO2
The proportion of subjects in each dose group who exhibited improvement from baseline in SpO2 levels, as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute, at Days 3 and 14
Measured: Days 3 and 14
Cumulative days on ventilator
Cumulative days on ventilator for each subject who required mechanical ventilation at any time during Day 1 to Day 14 period
Measured: Day 1 to 14
Duration of hospitalization
Subjects' duration of hospitalization over the Day1 to Day 14 period
Measured: Day 1 to 14
Time to clinical improvement
Subjects' time to clinical improvement (TTCI), which is defined as a National Early Warning Score 1 (NEWS2) of < 2 to be maintained for 24 h (during Days 1 to 14)
Measured: Day 1 to 14
Proportion of subjects experiencing TTCI
The proportions of subjects in each cohort who experienced TTCI, which is defined as NEWS2 of < 2 to be maintained for 24 h
Measured: Day 1 to 14
Subjects time to death
Subjects time to death or censoring over the period from Day 1 to Day 14 (subjects who withdraw prior to Day 14 will be censored on the day of withdrawal; subjects alive on Day 14 will be censored on Day 14)
Measured: Day 1 to 14
Change from baseline in Horowitz index
Subjects' change from baseline on Days 6 and 14 in Horowitz index or in SpO2/FiO2
Measured: Days 6 and 14
Subject's cumulative days in ICU
Subjects' cumulative number of days spent in the Intensive Care Unit (ICU) over Days 1 to 14
Measured: Day 1 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Dec 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Trial was terminated due to lack of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cohort 1 - 7 subjects will be randomized to receive SP16 6 mg or placebo in a 7:3 ratio. Cohort 2 - 7 subject will be randomized to receive SP16 12 mg or placebo in a 7:3 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serpin Pharma, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135624
- Sponsor's protocol ID
- IRBHSR#210341
- Status last verified
- May 2024
- First submitted
- 9 Nov 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
- ClinicalTrials.gov ID
- NCT05135624
- Acronym / sponsor ID
- IRBHSR#210341
- Conditions
- SARS CoV 2 Infection, Pneumonia
- Keywords
- Pneumonia due to SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated due to lack of patients.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Serpin Pharma, LLCUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Nov 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 randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.
Detailed description
SARS-CoV-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. SP16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. SP16's mechanism of action is through targeting LRP1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. The main objective of this study is to determine the safety and tolerability, and effects on inflammation of SP16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). SP16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. The study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the Intensive Care Unit (ICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Cohort 1 - 7 subjects will be randomized to receive SP16 6 mg or placebo in a 7:3 ratio. Cohort 2 - 7 subject will be randomized to receive SP16 12 mg or placebo in a 7:3 ratio.
| Arm | Type | Receives |
|---|---|---|
| Cohort dose 1 of SP16 | Experimental | Drug: SP16 (6mg)Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection |
| Cohort dose 2 of SP16 | Experimental | Drug: SP16 (12 mg)Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection |
| Placebo | Placebo comparator | Other: PlaceboPatients in placebo arm will receive sterile water by subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:
- Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive
- PCR test result and can provide informed consent
- Diagnosed with pneumonia due to SARS-CoV-2
- Respiratory rate ≥ 25/minute and SpO2 ≤ 93%
Key exclusion criteria (7 listed)
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Age < 18
- Pregnant or lactating women
- History of heart failure
- Clinically significant cardiac dysrhythmia, as determined by investigator
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 |
|---|---|---|
| SP16 (6mg)SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16 | Drug | Cohort dose 1 of SP16 |
| PlaceboPlacebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water | Other | Placebo |
| SP16 (12 mg)SP16 will be administered as a single 2 mL s.c. injection of 3 mg/mL SP16 and 1 concurrent separate 2 mL s.c. injection of sterile water | Drug | Cohort dose 2 of SP16 |
Primary outcome
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
Time frame: Day 1 to 14
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)
Change in inflammatory cytokines
Time frame: Day 3, Day 6, and Day 14
Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)
Change in acute phase reactants
Time frame: Day 3, Day 6, and Day 14
Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)
9 secondary outcomes
Proportion of subjects requiring ventilation
Time frame: Day 14
Improvement from baseline in SpO2
Time frame: Days 3 and 14
Cumulative days on ventilator
Time frame: Day 1 to 14
Duration of hospitalization
Time frame: Day 1 to 14
Time to clinical improvement
Time frame: Day 1 to 14
Proportion of subjects experiencing TTCI
Time frame: Day 1 to 14
Subjects time to death
Time frame: Day 1 to 14
Change from baseline in Horowitz index
Time frame: Days 6 and 14
Subject's cumulative days in ICU
Time frame: Day 1 to 14
Results and safety
The study was stopped early (reason given: Trial was terminated due to lack of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP16 (6mg) and SP16 (12 mg) in people with SARS CoV 2 Infection and Pneumonia, run by Serpin Pharma, LLC 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 7 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: stopped early, as of the sponsor's last update on 23 May 2024. 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 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.
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: Trial was terminated due to lack of patients.). 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?
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 (time frame: Day 1 to 14). The study lists 3 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 23 May 2024.