COVID-19 Treatment Trial: Investigational Medication as a Non-antiviral Immunomodulator

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    230
  • sponsor
    OncoImmune, Inc.
Updated on 17 June 2020

Summary

The study is designed to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19.  The investigational medication is called CD24Fc.

Participants will be randomly assigned to one of two treatment "arms" for the study and neither the participant, nor the study team will know which arm each participant is assigned to.
- Arm A: CD24Fc / Best Available Treatment
- Arm B: placebo / Best Available Treatment 

CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1 of the study. Total of 230 subjects will be enrolled; half will receive CD24Fc and half will receive placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

Details
Condition Coronavirus, COVID-19, *Corona Virus, Covid-19
Treatment Placebo, CD24Fc
Clinical Study IdentifierNCT04317040
SponsorOncoImmune, Inc.
Last Modified on17 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Should be at least 18 years of age
Male or female
Diagnosed with COVID-19 and confirmed SARS-coV-2 viral infection
Able to sign the consent form
Severe COVID-19 (Appendix A), or NIAID 8-point ordinal score 3 to 4 (requiring non-invasive ventilation or oxygen, a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min), Appendix B)

Exclusion Criteria

Patients with COVID 19 in critical condition or ARDS (Appendix A) or NIAID 8-point ordinal score 2 (Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO))
Patients with bacterial / fungal infections
Patients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment
Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)
Patients with known severe renal impairment (creatinine clearance 30 mL / min) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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