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

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 |

- 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 daysOther Names:
- Vasoactive Intestinal Peptide
- VIP

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

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
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 |

Study Chair: | Jonathan C Javitt, MD, MPH | NRx Pharmaceuticals, Inc. |
Documents provided by NeuroRx, Inc.:
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 |
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Vasoactive Intestinal Peptide Gastrointestinal Agents |
Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |