drugset / Trial / NCT05135624
SP16 as a Therapeutic for COVID-19 Induced ARDS
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.”