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

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

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%.