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

Short name SAMICARE

NCTNCT04453839Other idZYESAMI_EA-1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: No longer available
Phase: Phase not stated
Enrollment: Not stated
Sponsor: APR Applied Pharma Research s.a. · Other
Design: Not stated
Countries: 1 country
United States
Start: Not stated
Primary completion: Not stated
Completion: Not stated
First posted: 1 Jul 2020
Last update posted: 3 Feb 2023
Conditions: Critical COVID-19 With Respiratory Failure

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

ZYESAMI (aviptadil acetate)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 100 Years
Healthy volunteers: Not stated

Inclusion and exclusion criteria, as posted

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

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