Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05135624 · ClinicalTrials.gov registry record · Phase 1
SP16 as a Therapeutic for COVID-19 Induced ARDS
A Phase 1 study, sponsored by Serpin Pharma.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT05135624: Clinical Trial Phase 1 study, sponsored by Serpin Pharma.
NCT05135624 is a Phase 1 study that was terminated before completion, run by Serpin Pharma. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05135624, a Phase 1 study, was terminated before completion, sponsored by Serpin Pharma.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)
Interventions
- OTHER Placebo
- DRUG SP16 (6mg)
- DRUG SP16 (12 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
Why NCT05135624 stopped before completion
NCT05135624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05135624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05135624 about?
NCT05135624 is a clinical study titled "SP16 as a Therapeutic for COVID-19 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 elig...
What is the current status of trial NCT05135624?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-12-01. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT05135624?
The interventions under investigation include: Placebo (OTHER), SP16 (6mg) (DRUG), SP16 (12 mg) (DRUG).
Who is sponsoring clinical trial NCT05135624?
This trial is sponsored by Serpin Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05135624's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI