Relief Therapeutics Holding AG (RLFTF)

[threebabiesbusy]

https://clinicaltrials.gov/ct2/show/NCT04360096#outcomemeasures

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter Randomized Placebo-controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the study pharmacist will be aware of treatment assignment
Primary Purpose: Treatment
Official Title: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 30, 2020
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome
U.S. FDA Resources

Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Moderate COVID-19 RLF-100
Patients with Moderate COVID-19 to be treated with inhaled RLF-100 (aviptadil) by mesh nebulizer 100µg 3x daily
Drug: RLF-100 (aviptadil)
Inhaled RLF-100 (aviptadil) 100µg 3x daily by mesh nebulizer

Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Moderate COVID-19 Placebo
Patients with Moderate COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation

Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Severe COVID-19 RLF-100
Patients with Severe COVID-19 to be treated with inhaled RLF-100 (aviptadil) by mesh nebulizer 100µg 3x daily
Drug: RLF-100 (aviptadil)
Inhaled RLF-100 (aviptadil) 100µg 3x daily by mesh nebulizer

Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product

Experimental: Severe COVID-19 Placebo
Patients with Severe COVID-19 to be treated with inhaled placebo 3x daily
Drug: Placebo
Normal Saline Inhalation

Device: Nebulized administration of RLF-100 or Placebo
Use of 510(k) cleared mesh nebulizer to deliver investigational product



Outcome Measures
Go to sections
Primary Outcome Measures :
Progression to ARDS [ Time Frame: 28 days ]
Progression to ARDS is defined as the need for mechanical ventilation


Secondary Outcome Measures :
Blood oxygenation [ Time Frame: 28 days ]
Blood PO2 as measured by pulse oximetry

RDP Dsypnea Scale [ Time Frame: 28 days ]
0 = no shortness of breath at all 0.5 = very, very slight shortness of breath

= very mild shortness of breath
= mild shortness of breath
= moderate shortness of breath or breathing difficulty
= somewhat severe shortness of breath
= strong or hard breathing
7 = severe shortness of breath or very hard breathing 8 9 = extremely severe shortness of breath 10 = shortness of breath so severe you need to stop the exercise or activity


Distance walked in six minutes [ Time Frame: 28 days ]
Distance walked in six minutes


Eligibility Criteria
Go to sections
Information from the National Library of Medicine
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 85 Years (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Moderate or Severe COVID-19 by FDA definition with no evidence of Respiratory Failure
Capable of using mesh nebulizer to administer medication with assistance if needed
Exclusion Criteria:

Evidence of Respiratory Failure
Use or impending use of ventilation or high flow nasal oxygen 20L or greater
4) Age <12 years; 5) Diastolic pressure < 65 mm Hg; 6) Irreversible underlying condition with projected fatal course; 7) Immunosuppressive treatment for transplant or other reasons; 8) Cancer, renal failure, congestive heart failure, neurological disorder 9) Recent myocardial infarction with Troponin >0.5

Contacts and Locations
Go to sections
Information from the National Library of Medicine
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): NCT04360096


Contacts
Contact: Robert E Besthof, MIM [phone] [e-mail]

Sponsors and Collaborators
NeuroRx, Inc.
Investigators
Study Chair: Jonathan C Javitt, MD, MPH NeuroRx
More Information
Go to sections
Additional Information:
Javitt JC: Perspective: The potential role of vasoactive intestinal peptide in treating COVID-19 This link exits the ClinicalTrials.gov site
Pathogenesis of COVID-19 from a cell biologic perspective This link exits the ClinicalTrials.gov site

Responsible Party: NeuroRx, Inc.
ClinicalTrials.gov Identifier: NCT04360096 History of Changes
Other Study ID Numbers: RLF-100_002
First Posted: April 24, 2020 Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NeuroRx, Inc.:
Corona Virus
VIP
Aviptadil
Vasoactive Intestinal Polypeptide