Trials / Completed
CompletedNCT04676971
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
Efficacy and Safety of Intravenously Administered hzVSF-v13 in Patients With COVID-19 Pneumonia: a Phase II, Proof of Concept, Multicentre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- ImmuneMed, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
Detailed description
Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | hzVSF-v13 | Dosage form: 100mg / 200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1, 3, 7, D14(if necessary) |
| DRUG | Placebo (Normal saline solution) | Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary) |
Timeline
- Start date
- 2020-12-11
- Primary completion
- 2021-08-29
- Completion
- 2021-10-28
- First posted
- 2020-12-21
- Last updated
- 2021-12-01
Locations
9 sites across 2 countries: Italy, Russia
Source: ClinicalTrials.gov record NCT04676971. Inclusion in this directory is not an endorsement.