A USA-licensed physician

I am:

Before a Request is Made

Before deciding whether this drug might be appropriate for your patient, please read our Investigator’s Brochure and Scientific Overview which detail RLF-100’s mechanism of action, indications, dosing and administration, and known adverse events.

Request Expanded Access for Aviptadil (RLF-100) for your Patients

Dear physician

Thank you for your interest in the Expanded Access Program for Aviptadil (RLF-100). This program was authorized by the FDA as an Intermediate-size Expanded Access Program. Please note that this medication has not been approved by the FDA for any indication and is currently being studied in a clinical study of Intravenous Aviptadil for Critical COVID-19 with Respiratory Failure NCT04311697 (COVID-AIV).

Our Expanded Access Program is being managed by Clinigen.

Please note that NeuroRx and Clinigen are receiving a high volume of requests and we are working expeditiously to address these.

Due to the volume of requests, NeuroRx is unable to reply to voice mail messages on our system.

Name *

First

Last

Email *

Cell Phone *

Eligibility criteria #1 *

I am a US-licensed physician

Eligibility criteria #2 *

I am subspecialty-boarded and practice critical care medicine in the ICU setting.

Eligibility criteria #3 *

I am treating various patients who have Respiratory Failure caused by COVID-19 and my intensive care unit has treated more than 30 Critical COVID-19 patients since March 2020.

(Respiratory Failure is defined by the FDA as the requirement for mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in excess of 20L/hr in order to maintain blood oxygen saturation.)

Eligibility criteria #4 *

I have exhausted all currently-approved therapeutic options that might reasonably help various of our patients (more than 1).

At this time, we are focused on institutions that expect to treat numerous patients under an Expanded Access Program.

Eligibility criteria #5 *

I understand that RLF-100 is an investigational drug for which no determination of safety or efficacy has been made by the US Food and Drug Administration.

Eligibility criteria #6 *

My hospital is prepared to accept the IRB oversight of the Advarra central IRB (www.advarra.com) and I recognize that neither the protocol nor the consent can be altered by my local IRB.

Eligibility criteria #7 *

My hospital has a pharmacy – that is well prepared to receive, cold-chain (2-8º degrees Celsius) investigational products – such as Aviptadil, and is able to prepare and dispense a 12hr-18hr infusion with a very low infusion volume through a standard infusion pump.

Eligibility criteria #8 *

My hospital has nursing staff that is skilled in administering investigational products, and closely monitoring patients accordingly, I or appropriately qualified physicians will be supervising this staff during administration.

Eligibility criteria #9

Optional: In addition to participating in the Expanded Access program, I would like to be considered as an investigator for your phase 3 clinical trials. My hospital has a research pharmacy and a clinical trials infrastructure

Comment

Get information about the COVID-19 Expanded Access program

Learn more