Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04400058 · ClinicalTrials.gov registry record · Phase 3
Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 207
- Enrollment target
NCT04400058: Completed Phase 3 study, sponsored by Octapharma.
NCT04400058 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 207 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04400058, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 207 participants
- Enrollment target
Study 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
Primary Outcome
Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/H
Interventions
- OTHER Saline Solution
- BIOLOGICAL Octagam 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 3 |
What the finished NCT04400058 record still lists
NCT04400058 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline Solution is the first listed.
NCT04400058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04400058 about?
NCT04400058 is a clinical study titled "Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression". 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
What is the current status of trial NCT04400058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2020-06-01. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT04400058?
The interventions under investigation include: Saline Solution (OTHER), Octagam 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT04400058?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04400058's enrollment target sits among peer trials
207 1346th of 2000 higher than 654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04353778 · 207 participants · Phase 1
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
- NCT05875805 · 207 participants · NA
A Telehealth Advance Care Planning Intervention
- NCT06254950 · 207 participants · Phase 2
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
- NCT06904274 · 207 participants · Phase 3
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI