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Anti-inflammatory Drug
SP16 for COVID-19
Phase 1 & 2
Waitlist Available
Research Sponsored by Serpin Pharma, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, day 6, and day 14
Awards & highlights
Study Summary
This trial is testing a new anti-inflammatory drug, SP16, to see if it is safe and effective in treating pneumonia caused by the SARS-CoV-2 virus. Up to 20 patients will be enrolled and randomly assigned to receive either SP16 or a placebo.
Who is the study for?
This trial is for adults over 18 hospitalized with COVID-19 pneumonia, confirmed by a positive PCR test. They must have significant breathing difficulty (respiratory rate ≥ 25/minute and SpO2 ≤ 93%) and evidence of lung infection on imaging tests. Excluded are those with heart failure, kidney issues, serious heart rhythm problems, or pregnant/lactating women.Check my eligibility
What is being tested?
The study is testing SP16, an anti-inflammatory drug at two different doses (6 mg or 12 mg) versus a placebo. It's to see how safe it is and its effect on inflammation markers in patients with severe COVID-19 related pneumonia.See study design
What are the potential side effects?
While the specific side effects of SP16 aren't listed here, as an anti-inflammatory drug being tested in severely ill patients, potential side effects could include reactions at the injection site, allergic responses, changes in blood pressure or blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, hospitalized with COVID-19 confirmed by a PCR test, and can consent.
Select...
I have been diagnosed with COVID-19 pneumonia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3, day 6, and day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, day 6, and day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in acute phase reactants
Body Weight Changes
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
Secondary outcome measures
Change from baseline in Horowitz index
Cumulative days on ventilator
Duration of hospitalization
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort dose 2 of SP16Experimental Treatment1 Intervention
Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection
Group II: Cohort dose 1 of SP16Experimental Treatment1 Intervention
Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection
Group III: PlaceboPlacebo Group1 Intervention
Patients in placebo arm will receive sterile water by subcutaneous injection.
Find a Location
Who is running the clinical trial?
Serpin Pharma, LLCLead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled
University of VirginiaOTHER
753 Previous Clinical Trials
1,245,011 Total Patients Enrolled
5 Trials studying COVID-19
10,137 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your Horowitz index (which measures how well your lungs are working) is below a certain level, or your SpO2/FiO2 (a different measure of lung function) is below a certain level if you don't have an arterial line.I have a history of heart failure.I have had kidney problems in the past.My heart rhythm is normal as confirmed by a doctor.I am under 18 years old.I am over 18, hospitalized with COVID-19 confirmed by a PCR test, and can consent.Your breathing rate is very fast, and the oxygen level in your blood is low.Your blood tests show low levels of a type of white blood cells called neutrophils, or high levels of a liver enzyme called aspartate aminotransferase.I have been diagnosed with COVID-19 pneumonia.Your chest X-ray, CT scan, or ultrasound shows signs of infection in both lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cohort dose 1 of SP16
- Group 3: Cohort dose 2 of SP16
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for new participants in this trial?
"The latest information from clinicaltrials.gov shows that this trial is currently enrolling patients. The study was first announced on December 1st, 2021 and has had 10 edits since then."
Answered by AI
Why did researchers design this experiment in this particular way?
"The primary outcome being assessed in this clinical trial over days 3, 6 and 14 is change in acute phase reactants. Additionally, the secondary outcomes include the proportion of subjects experiencing TTCI defined as NEWS2 score of less than 2 maintained for 24 hours, cumulative ICU days spent by subjects, and the proportion of subjects requiring ventilation by day 14."
Answered by AI
What is the upper limit for how many people can join this trial?
"Indeed, the information available on clinicaltrials.gov affirms that this trial is actively seeking patients. This research was originally posted on December 1st 2021 and updated most recently on December 10th 2021. Currently, the study has 20 slots open for willing participants at a single location."
Answered by AI
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