Trial · NCT04400058

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

NCT04400058, Phase 3, Completed, Octapharma; results first posted 2024-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression. Trials, record NCT04400058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04400058

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
NCT number: NCT04400058
Status: Completed
Phases: Phase 3
Enrollment: 207 participants, actual
Lead sponsor: Octapharma
Conditions: Covid-19
Interventions: Octagam 10%, Saline Solution
First posted: 2020-05-22
Last updated: 2024-01-18
Results first posted: 2024-01-18
Limitations and caveats: Post-hoc outcomes were recorded for subjects who chose to enter the post-study phone call registry, therefore, the numbers differ from the overall study population.

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	7 days	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/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
Secondary	Length of Hospital Stay (Time to Discharge)	33 days	Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33
Secondary	Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	14 days	Number of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. 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/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥ 150 mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
Secondary	Cumulative Duration of Invasive Mechanical Venitlation (IMV)	33 days	Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33
Secondary	Number of Subjects With Severe Disease Progression	33 days	Number of subjects who experienced severe disease progression while treated with Octagam 10% compared to those that received placebo at Day 33. Severe disease progression is defined as subjects requiring extracorporeal membrane oxygenation, mechanical ventilation and/or died through day 33.
Secondary	ICU Stay Length	33 days	Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.
Secondary	Cumulative Mortality Rate Through Day 33	33 days	Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33

Source ClinicalTrials.gov

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	7 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Length of Hospital Stay (Time to Discharge)	33 days	days	MEDIAN
SECONDARY	Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	14 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cumulative Duration of Invasive Mechanical Venitlation (IMV)	33 days	days	MEAN
SECONDARY	Number of Subjects With Severe Disease Progression	33 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	ICU Stay Length	33 days	days	MEAN
SECONDARY	Cumulative Mortality Rate Through Day 33	33 days	Participants	COUNT_OF_PARTICIPANTS
POST_HOC	Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire)	3 months post-study	participants	NUMBER
POST_HOC	Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire)	6 months post-study	participants	NUMBER
POST_HOC	Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire)	9 months post-study	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group198

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	Octagam 10%	89		Participants
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	Placebo	82		Participants
Length of Hospital Stay (Time to Discharge)	Octagam 10%	12	95% Confidence Interval 9 to 14	days
Length of Hospital Stay (Time to Discharge)	Placebo	11	95% Confidence Interval 9 to 15	days
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	Octagam 10%	86		Participants
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	Placebo	83		Participants
Cumulative Duration of Invasive Mechanical Venitlation (IMV)	Octagam 10%	2.7	Standard Deviation 8.05	days
Cumulative Duration of Invasive Mechanical Venitlation (IMV)	Placebo	1.6	Standard Deviation 5.95	days
Number of Subjects With Severe Disease Progression	Octagam 10%	15		Participants
Number of Subjects With Severe Disease Progression	Placebo	12		Participants

1 to 10 of 198Source ClinicalTrials.gov

See all 198 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Octagam 10%	105
Overall Study	STARTED	Saline Solution	102
Overall Study	COMPLETED	Octagam 10%	84
Overall Study	COMPLETED	Saline Solution	86
Overall Study	NOT COMPLETED	Octagam 10%	21
Overall Study	NOT COMPLETED	Saline Solution	16

Source ClinicalTrials.gov

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Octagam 10%	10	105	10
other	Constipation	Gastrointestinal disorders	Placebo	8	100	8
other	Diarrhoea	Gastrointestinal disorders	Octagam 10%	6	105	6
other	Diarrhoea	Gastrointestinal disorders	Placebo	7	100	7
other	Hyperglycemia	Metabolism and nutrition disorders	Octagam 10%	7	105	7
other	Hyperglycemia	Metabolism and nutrition disorders	Placebo	4	100	4
other	Hyponatraemia	Metabolism and nutrition disorders	Octagam 10%	7	105	7
other	Hyponatraemia	Metabolism and nutrition disorders	Placebo	4	100	4
other	Hypokalemia	Metabolism and nutrition disorders	Octagam 10%	3	105	3
other	Hypokalemia	Metabolism and nutrition disorders	Placebo	6	100	6

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Octagam 10%	13	105
Total, all-cause mortality	Placebo	6	102
Total, other adverse events	Octagam 10%	49	105
Total, other adverse events	Placebo	40	100
Total, serious adverse events	Octagam 10%	15	105
Total, serious adverse events	Placebo	12	100

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Octagam 10% vs Placebo: Number of Subjects With Severe Disease Progression	Trial comparisons
Octagam 10% vs Placebo: Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	Trial comparisons
Octagam 10% vs Placebo: Cumulative Mortality Rate Through Day 33	Trial comparisons
Octagam 10% vs Placebo: deaths from any cause	Trial comparisons
Octagam 10% vs Placebo: Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	Trial comparisons
Octagam 10% vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04400058

GET https://conductscience.org/api/trials/v1/NCT04400058/results?page=2

API reference For AI assistants