Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)

Status:

NO_LONGER_AVAILABLE

Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)

Lead Sponsor:

Implicit Bioscience

Conditions:

COVID

ARDS, Human

Eligibility:

All Genders

18-70 years

Brief Summary

This protocol proposes to use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing human CD14, to block CD14-mediated cellular activation in patients early in the development of ARDS. Th...

Detailed Description

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 da...

Eligibility Criteria

Inclusion

Signed informed consent form and able to give informed consent
Age 18-70 years
Presence of a SARS-CoV-2 infection documented by nasopharyngeal swab positive by RT-PCR testing or history of positive test
Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection
Hypoxemia as defined by any of the following:
SpO2 ≤92% on room air
Requirement for \>2L O2 per standard nasal cannula
PaO2/FiO2\<300 if on high-flow nasal cannula
Women of childbearing potential must have a negative pregnancy test

Exclusion

A patient fulfilling any of the following criteria is to be excluded from enrollment in the study:
Intubation
Do-not-attempt resuscitation (DNAR) / do not intubate status
Anticipated survival \<48 hours
Anticipated survival \<28 days due to pre-existing medical condition
Significant pre-existing organ dysfunction
Lung: Currently receiving home oxygen therapy as documented in medical record
Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
Renal: Chronic renal failure requiring renal replacement therapy
Liver: Severe chronic liver disease defined as Child-Pugh Class C
Pre-existing, ongoing immunosuppression
Solid organ transplant recipient
Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days)
Oncolytic drug therapy within the past 14 days
Known HIV positive with CD4 count \<200 cells/mm3
Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), Arcalyst® (rilonacept), or other potent immunosuppressant
Pregnancy
History of hypersensitivity or idiosyncratic reaction to IC14

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04346277

Last Update

June 21 2021

Active Locations (1)

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