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ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) (SAMICARE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453839
Expanded Access Status : Available
First Posted : July 1, 2020
Last Update Posted : January 31, 2022
Sponsor:
Collaborators:
Cavendish Impact Foundation
Clinigen, Inc.
Nephron Pharmaceuticals, Inc.
Information provided by (Responsible Party):
NeuroRx, Inc.

Study Description
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Brief Summary:

Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor.

Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization.

Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download


Condition or disease Intervention/treatment
Critical COVID-19 With Respiratory Failure Drug: ZYESAMI (aviptadil acetate)

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Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: ZYESAMI (aviptadil acetate)
    Patients will be treated with 12 hour infusions of ZYESAMI at ascending doses of 50/100/150 pmol/kg/hr on 3 or more successive days
    Other Names:
    • Vasoactive Intestinal Peptide
    • VIP
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Critical COVID-19 with Respiratory Failure

Exclusion Criteria:

  • Patients who are eligible for enrollment in RLF-100_001 are excluded from this protocol and live within 50 miles of a study site for NCT04311697 cannot be enrolled unless already admitted to an ICU and ineligible for transfer
  • Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
  • Irreversible condition (other than COVID-19) with projected fatal course
  • ECMO
  • Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
  • Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
  • Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation
Contacts and Locations
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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): NCT04453839


Contacts
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Contact: Robert E Besthof, MIM +14842546135 expandedaccess@neurorxpharma.com
Contact: For Right to Try Requests https://www.nrxpharma.com/right-to-try/ expandedaccess@neurorxpharma.com

Locations
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Sponsors and Collaborators
NeuroRx, Inc.
Cavendish Impact Foundation
Clinigen, Inc.
Nephron Pharmaceuticals, Inc.
Investigators
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Study Chair: Jonathan C Javitt, MD, MPH NRx Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by NeuroRx, Inc.:
Study Protocol  [PDF] August 15, 2020
Informed Consent Form  [PDF] October 19, 2020

More Information
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Additional Information:

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Responsible Party: NeuroRx, Inc.
ClinicalTrials.gov Identifier: NCT04453839    
Other Study ID Numbers: ZYESAMI_EA-1
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Vasoactive Intestinal Peptide
Gastrointestinal Agents
 Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs