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 19 February 2024

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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	18-89 years
Treatment	Standard of Care, Ampion
Clinical Study Identifier	NCT04456452
Sponsor	Ampio Pharmaceuticals. Inc.
Last Modified on	19 February 2024

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