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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456452
Recruitment Status : Completed
First Posted : July 2, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Ampion Other: Standard of Care Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation
Actual Study Start Date : July 27, 2020
Actual Primary Completion Date : September 8, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Ampion
Ampion
Biological: Ampion
Ampion, administered by intravenous infusion

Other: Standard of Care
Standard of Care

Standard of Care
Standard of Care
Other: Standard of Care
Standard of Care




Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Primary endpoint at day 5 ]
    Incidence and severity of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
  2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
  3. Patient is on chronic immunosuppressive medication.
  4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
  5. 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).
  6. Patient has known pregnancy or is currently breastfeeding.
  7. Participation in another clinical trial.
  8. Baseline QT prolongation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456452


Locations
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United States, Colorado
Research Site
Colorado Springs, Colorado, United States, 80907
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
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Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT04456452    
Other Study ID Numbers: AP-016
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No