COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04311697

Jonathan C Javitt, MD, MPH

Robert E Besthof, rbesthof@neurorxpharma.com (PI email not reported)

2020-03-17

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - critical covid-19 with respiratory failure - physician determination that patient is on maximal conventional medical therapy

pregnancy (pregnant women may apply for open label treatment under compassionate care ind age <18 years 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 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 > 0.5 anuria (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; 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

2

APR Applied Pharma Research s.a.

18

100

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

203

Resolution of Respiratory Failure (Alive and Free of Respiratory Failure)

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 154, "treatment_name": "Aviptadil", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]