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Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

NCT04400058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2024-01-18

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease

Conditions

Interventions

BIOLOGICAL

Octagam 10%

Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days

OTHER

Saline Solution

Placebo

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States
  • Russia
  • Ukraine

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 NCT04400058 on ClinicalTrials.gov