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 : March 19, 2021
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 successive days
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, MIMemail@example.com|
|Study Chair:||Jonathan C Javitt, MD, MPH||NeuroRx, Inc.|