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Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia

NCT04676971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-12-01

No results posted yet for this study

Summary

Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.

Conditions

Interventions

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)

Sponsors & Collaborators

  • ImmuneMed, Inc.

    lead INDUSTRY

Principal Investigators

  • Davide Sonnino, phD · OPIS s.r.l

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2021-08-29
Completion
2021-10-28

Countries

  • Italy
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676971 on ClinicalTrials.gov