drugset / Trial / NCT05135624

SP16 as a Therapeutic for COVID-19 Induced ARDS

NCT05135624 ↗

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-12-01
Primary completion
2023-06-30
Completion
2023-06-30

Outcome

Outcome not reported

Stopped: “Trial was terminated due to lack of patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject SP16 Peptide 6 mg Subcutaneous
Subject SP16 Peptide 12 mg Subcutaneous

Indications