Sars-CoV2
Conditions
Keywords
Coronavirus, IVIG, COVID-19
Brief summary
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
Detailed description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.
Interventions
DRUGOctagam
Standard of Care plus Octagam infusion for 3 days.
Sponsors
Octapharma
George Sakoulas, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed COVID-19 positive test result (including presumptive positive). * Hospitalization * Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated * Age ≥18 years old. * Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail. * Able to read/write/speak English or Spanish fluently. * Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent. provide informed consent, and provide authorization of use and disclosure of personal health information. * Negative pregnancy test for women of childbearing potential.
Exclusion criteria
* Severe allergy to any IVIG product formulation * History of DVT, PE, thromboembolic stroke or other thrombotic events * Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn. * Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg) * Active participant in another research treatment study * Mechanically ventilated patient * Code status is Do Not Resuscitate or Do Not Intubate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | Number of subjects requiring mechanical ventilation due to respiratory failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Therapy | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days | Number of days requiring oxygen therapy |
| Length of Stay | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days | Number of days in hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A (Study Drug+SOC) Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days. | 16 |
| Group B (SOC) Standard of Care | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Group B (SOC) | Group A (Study Drug+SOC) | Total |
|---|---|---|---|
| Age, Continuous | 51 years | 59 years | 56 years |
| Body Mass Index | 34.9 kg/m^2 | 32.5 kg/m^2 | 33.6 kg/m^2 |
| Comorbidities Asthma/chronic obstructive pulmonary disease | 2 Participants | 2 Participants | 4 Participants |
| Comorbidities Chronic kidney disease | 1 Participants | 0 Participants | 1 Participants |
| Comorbidities Congestive heart failure | 1 Participants | 1 Participants | 2 Participants |
| Comorbidities Coronary artery disease | 1 Participants | 1 Participants | 2 Participants |
| Comorbidities Current smoker | 1 Participants | 1 Participants | 2 Participants |
| Comorbidities Diabetes mellitus | 6 Participants | 6 Participants | 12 Participants |
| Comorbidities Former smoker | 1 Participants | 2 Participants | 3 Participants |
| Comorbidities Hypertension | 7 Participants | 4 Participants | 11 Participants |
| Comorbidities Immunocompromised | 0 Participants | 1 Participants | 1 Participants |
| Comorbidities Continued (HbA1c) | 6.4 % glycosylated hemoglobin | 10.1 % glycosylated hemoglobin | 8.1 % glycosylated hemoglobin |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 13 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Other Coronavirus Disease 2019 Therapies Convalescent plasma | 3 Participants | 2 Participants | 5 Participants |
| Other Coronavirus Disease 2019 Therapies Glucocorticoids | 10 Participants | 16 Participants | 26 Participants |
| Other Coronavirus Disease 2019 Therapies Remdesivir | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 3 / 17 |
| other Total, other adverse events | 7 / 16 | 8 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Mechanical Ventilation
Number of subjects requiring mechanical ventilation due to respiratory failure
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (Study Drug+SOC) | Mechanical Ventilation | 2 Participants |
| Group B (SOC) | Mechanical Ventilation | 7 Participants |
Secondary
Length of Stay
Number of days in hospital
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A (Study Drug+SOC) | Length of Stay | 12 days |
| Group B (SOC) | Length of Stay | 17 days |
Secondary
Oxygen Therapy
Number of days requiring oxygen therapy
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Population: This data was not collected although it was originally intended to be an outcome measure