CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Octagam 10%Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018450 Disease Progression NIH 0.26

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Efficacy and Safety of 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

NCT04400058 Covid-19 Biological: Octagam 10% Other: Placebo
MeSH:Disease Progression

Primary Outcomes

Description: Proportion of subjects with stabilized or improved clinical status at Day 7 on at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Stabilization or Improvement in Clinical Status

Time: 7 days

Description: Change from Baseline (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis). Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Descriptive Clinical Status Analysis

Time: 7 days

Secondary Outcomes

Description: Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure) Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.

Measure: Clinical Status Assessment

Time: 14 days

Description: Time to death

Measure: Time to death

Time: Up to 33 days

Description: Proportion of subjects requiring invasive mechanical ventilation by Day 33.

Measure: Mechanical Ventilation Initiation

Time: Up to 33 days

Description: Duration of invasive mechanical ventilation

Measure: Mechanical Ventilation Duration

Time: Up to 33 days

Description: Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.

Measure: SARS-CoV-2 Test Result

Time: 7 days

Description: Incidence of all AEs

Measure: Incidence of all AEs

Time: Up to 33 days

Description: Incidence of AEs considered related to the IMP

Measure: Incidence of AEs considered related to the IMP

Time: Up to 33 days

Description: Incidence of serious adverse events (SAEs)

Measure: Incidence of serious adverse events (SAEs)

Time: Up to 33 days

Description: Radiological findings (chest CT/chest X-ray)

Measure: Radiological findings (chest CT/chest X-ray)

Time: Up to 7 days

Description: Change from baseline in blood glucose

Measure: Blood glucose

Time: Up to 33 daya

Description: Change from baseline in blood calcium

Measure: Blood calcium

Time: Up to 33 days

Description: Change from baseline in sodium

Measure: Sodium

Time: Up to 33 days

Description: Change from baseline in potassium

Measure: Potassium

Time: Up to 33 days

Description: Change from baseline in carbon dioxide

Measure: Carbon dioxide

Time: Up to 33 days

Description: Change from baseline in chloride

Measure: Chloride

Time: Up to 33 days

Description: Change from baseline in albumin

Measure: Albumin

Time: Up to 33 days

Description: Change from baseline in total protein

Measure: Total protein

Time: Up to 33 days

Description: Change from baseline in alkaline phosphatase

Measure: Alkaline phosphatase

Time: Up to 33 days

Description: Change from baseline in alanine transaminase

Measure: Alanine transaminase

Time: Up to 33 days

Description: Change from baseline in aspartate aminotransferase

Measure: Aspartate aminotransferase

Time: Up to 33 days

Description: Change from baseline in bilirubin

Measure: Bilirubin

Time: Up to 33 days

Description: Change from baseline in blood urea nitrogen

Measure: Blood urea nitrogen

Time: Up to 33 days

Description: Change from baseline in D-dimer

Measure: D-dimer

Time: Up to 33 days

Description: Change from baseline in fibrinogen

Measure: Fibrinogen

Time: Up to 33 days

Description: Change from baseline in PT

Measure: PT

Time: Up to 33 days

Description: Change from baseline in PTT

Measure: PTT

Time: Up to 33 days

Description: Change from baseline in INR

Measure: INR

Time: Up to 33 days

Description: Change from baseline in hsCRP

Measure: hsCRP

Time: Up to 33 days

Description: Change from baseline in ferritin

Measure: Ferritin

Time: Up to 33 days

Description: Change from baseline in LDH

Measure: LDH

Time: Up to 33 days

Description: Change from baseline in IgG

Measure: IgG

Time: Up to 33 days

Description: Change from baseline in IgM

Measure: IgM

Time: Up to 33 days

Description: Change from baseline in IgA

Measure: IgA

Time: Up to 33 days

Description: Change from baseline in IFE

Measure: IFE

Time: Up to 33 days

Description: Change from baseline in troponin

Measure: Troponin

Time: Up to 33 days

Description: Change from baseline in red blood cell count

Measure: Red blood cell count

Time: Up to 33 days

Description: Change from baseline in hemoglobjn

Measure: Hemoglobin

Time: Up to 33 days

Description: Change from baseline in hematocrit

Measure: Hematocrit

Time: Up to 33 days

Description: Change from baseline in mean corpuscular volume

Measure: Mean corpuscular volume

Time: Up to 33 days

Description: Change from baseline in mean corpuscular hemoglobin

Measure: Mean corpuscular hemoglobin

Time: Up to 33 days

Description: Change from baseline in mean corpuscular hemoglobin concentration

Measure: Mean corpuscular hemoglobin concentration

Time: Up to 33 days

Description: Change from baseline in red cell distribution width

Measure: Red cell distribution width

Time: Up to 33 days

Description: Change from baseline in white blood cell count

Measure: White blood cell count

Time: Up to 33 days

Description: Change from baseline in white blood cell differential

Measure: White blood cell differential

Time: Up to 33 days

Description: Change from baseline in platelet count

Measure: Platelet count

Time: Up to 33 days

Description: Change from baseline in mean platelet volume

Measure: Mean platelet volume

Time: Up to 33 days

Description: Change from baseline in platelet distribution width

Measure: Platelet distribution width

Time: Up to 33 days

Description: Change from baseline in SpO2

Measure: SpO2

Time: Up to 33 days

Description: Change from baseline in A-a gradient

Measure: A-a gradient

Time: Up to 33 days

Description: Change from baseline in blood pressure

Measure: Blood Pressure

Time: Up to 33 days

Description: Change from baseline in pulse

Measure: Pulse

Time: Up to 33 days

Description: Change from baseline in respiration rate

Measure: Respiration Rate

Time: Up to 33 days

Description: Change from baseline in body temperature

Measure: Body Temperature

Time: Up to 33 days


No related HPO nodes (Using clinical trials)