RLF-100 is currently in clinical trials. The US FDA has granted us Fast Track Designation and an Expanded Access Protocol, making a determination as provided in section 506(b) of the Food, Drug, and Cosmetics Act that RLF-100 is “intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”
Neither NeuroRx nor the FDA knows at this point whether RLF-100 is safe and effective – just that it has the potential to be safe and effective to treat COVID-19 Respiratory Failure.
Our drug is currently in FDA phase 2/3 clinical trials and if you or your loved one can participate in those clinical trials, we hope that you will do so. However, some people live more than 100 miles from the nearest study site (currently Miami, Houston, Irvine (CA), Louisvile, and Los Angeles. Others have pre-existing medical conditions that make them ineligible for the clinical trial. Those conditions are:
- Mechanical ventilation for more than 7 days in primary cohort. Mechanical ventilation>21 days in the exploratory cohort
- Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
- Irreversible condition (other than COVID-19) with projected fatal course
- Treatment with Extracorporeal Membrane Oxygenation (ECMO)
- Current or recent (within 30 d) enrollment in another investigational trial of anti-IL6 drug
- Active diagnosis of Acquired immune deficiency syndrome
- Transplant patients currently immunosuppressed
- Chemotherapy-induced neutropenia (granulocyte count <1000/mm3)
- Cardiogenic shock; congestive heart failure – NYHA Class 3 or 4
- Recent myocardial infarction – within last 6 months and troponin > 0.5uria (urine output < 50 ml/d) or other signs of multi-organ failure
- Severe liver disease with portal hypertension
- Recent stroke or head trauma within last 12 months
- Increased intracranial pressure, or other serious neurologic disorder
If you have one of these conditions, you may be able to receive our drug under expanded access. However, only your doctor can help us make that determination.
If you can possibly be treated at one of our clinical trial sites, please contact the Principal Investigator for that site. You can find the updated investigator list with contact information at the Clinical Trial section below for NCT04453839.
If you cannot be treated at one of our existing clinical trial sites, you can be treated at a hospital near you only if a board-certified critical care doctor is prepared to enroll as an investigator in our expanded access program and complete the documentation required by the US FDA. This will take about an hour of your doctor’s time to complete.
Because of the life-threatening nature of COVID-19 respiratory failure, our drug – at this point in time – is only being given in the Intensive Care setting and we can only include physicians who are expert at critical care as investigators under our expanded access protocol.
Before asking your doctor to consider enrolling with us as an investigator, please read the patient consent form. And make sure that you are willing to give your consent for treatment if your doctor decides that you are eligible and decides to enroll as an investigator in this protocol.
We hope that the above has been helpful to you and we look forward to a day when our drug is no longer investigational and available to all in need.
On behalf of NeuroRx and Relief Therapeutics, our prayers are with you for a speedy recovery.
Jonathan C. Javitt, MD, MPH
CEO and Chairman, NeuroRx, Inc.