drugset / Trial / NCT04458298
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
RandomizedSequentialDouble-blindTreatment
Summary
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients. A further secondary objective of Stage 2 of this study is: To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.
Timeline
- Start
- 2020-08-11
- Primary completion
- 2022-08-12
- Completion
- 2022-08-12
Outcome
Outcome not reported
Stopped (Enrollment): “Lack of enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ACETYLCYSTEINE ZIDRIMER | Small molecule | 2 mg/kg | Intravenous |
| Subject | ACETYLCYSTEINE ZIDRIMER | Small molecule | 4 mg/kg | Intravenous |
| Subject | ACETYLCYSTEINE ZIDRIMER | Small molecule | 8 mg/kg | Intravenous |