Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Ampio Pharmaceuticals. Inc.
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Updated on 5 August 2020
See if I qualify
dyspnea
oximetry
covid-19
SARS
oxygen supplementation
acute respiratory syndrome (sars)

Summary

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.

Details
Condition Covid 19
Age 18years - 89years
Treatment Standard of Care, Ampion
Clinical Study IdentifierNCT04456452
SponsorAmpio Pharmaceuticals. Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female, 18 years to 89 years old (inclusive)
Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2
Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion)
A signed informed consent form from the patient or the patient's legal representative must be available

Exclusion Criteria

In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments
Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.)
Patient is on chronic immunosuppressive medication
As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
Patient has known pregnancy or is currently breastfeeding
Participation in another clinical trial
Baseline QT prolongation
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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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