SP16 (6mg) for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
COVID-19+1 MoreSP16 (6mg) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • COVID-19
  • Pneumonia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
BNT162b2 Bivalent 30 µg + BNT162b4 5 µg
1
PRIME-2-CoV_Beta
1
CV0501 (6 μg)

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Day 3, Day 6, and Day 14

Day 1 to 14
Cumulative days on ventilator
Duration of hospitalization
Proportion of subjects experiencing TTCI
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
Subject's cumulative days in ICU
Subjects time to death
Time to clinical improvement
Day 14
Proportion of subjects requiring ventilation
Day 14
Change in acute phase reactants
Body Weight Changes
Days 3 and 14
Improvement from baseline in SpO2
Days 6 and 14
Change from baseline in Horowitz index

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
BNT162b2 Bivalent 30 µg + BNT162b4 5 µg
1
PRIME-2-CoV_Beta
1
CV0501 (6 μg)

Trial Design

3 Treatment Groups

Cohort dose 2 of SP16
1 of 3
Cohort dose 1 of SP16
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

20 Total Participants · 3 Treatment Groups

Primary Treatment: SP16 (6mg) · Has Placebo Group · Phase 1 & 2

Cohort dose 2 of SP16
Drug
Experimental Group · 1 Intervention: SP16 (12 mg) · Intervention Types: Drug
Cohort dose 1 of SP16
Drug
Experimental Group · 1 Intervention: SP16 (6mg) · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 3, day 6, and day 14

Who is running the clinical trial?

University of VirginiaOTHER
687 Previous Clinical Trials
1,464,258 Total Patients Enrolled
5 Trials studying COVID-19
10,459 Patients Enrolled for COVID-19
Serpin Pharma, LLCLead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have bilateral infiltrates on a chest radiograph, chest CT scan, or chest ultrasound.
You are hospitalized with a diagnosis of SARS-CoV-2-infection based on positive laboratory test results.
You have a respiratory rate of 25 or more breaths per minute and a SpO2 of less than 93%.
References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top