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Keep this study
Lead
Implicit Bioscience
This is a compassionate use open label program in patients hospitalized with pulmonary complications of SARS-CoV-2 infection who will receive IC14 at a dosage of 4 mg/kg on Day 1, then 2 mg/kg once daily on Days 2-4. Patient monitoring will be for a total of up to 28 days if the patient is still hospitalized.
Screening/baseline assessments and initiation of the first IC14 administration will occur within 48 hours after meeting inclusion criteria. IC14 should be administered at approximately 24-hr intervals beginning from the start time of the first IC14 administration (Day 1).
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Signed informed consent form and able to give informed consent
2. Age 18-70 years
3. Presence of a SARS-CoV-2 infection documented by nasopharyngeal swab positive by RT-PCR testing or history of positive test
4. Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection
5. Hypoxemia as defined by any of the following:
1. SpO2 ≤92% on room air
2. Requirement for \>2L O2 per standard nasal cannula
3. PaO2/FiO2\<300 if on high-flow nasal cannula
6. Women of childbearing potential must have a negative pregnancy test
You may not be if
A patient fulfilling any of the following criteria is to be excluded from enrollment in the study:
1. Intubation
2. Do-not-attempt resuscitation (DNAR) / do not intubate status
3. Anticipated survival \<48 hours
4. Anticipated survival \<28 days due to pre-existing medical condition
5. Significant pre-existing organ dysfunction
1. Lung: Currently receiving home oxygen therapy as documented in medical record
2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
4. Liver: Severe chronic liver disease defined as Child-Pugh Class C
6. Pre-existing, ongoing immunosuppression
1. Solid organ transplant recipient
2. Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days)
3. Oncolytic drug therapy within the past 14 days
4. Known HIV positive with CD4 count \<200 cells/mm3
7. Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), Arcalyst® (rilonacept), or other potent immunosuppressant
8. Pregnancy
9. History of hypersensitivity or idiosyncratic reaction to IC14
Clareo Health | Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)
