COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05137795

Jonathan C Javitt

Not reported

2021-11-30

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: severe covid-19 , as defined by clinical signs indicative of severe systemic illness with covid-19, being given oxygenation and meeting one of the following: respiratory rate ≥ 30 per minute heart rate ≥ 125 per minute spo2 ≤ 93% on room air at sea level pao2/fio2 < 300 mmhg or spo2/fio2 < 315 mmhg positive test by standard rt-pcr assay or equivalent within last 7 days physician determination that patient is on soc therapy, and will receive standard of care if patient progresses to critical covid-19, patient must be full code

evidence of critical covid-19 inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications age <12 years; mean arterial pressure < 65 mm hg after initial hospital stabilization, non-covid-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality; immunosuppressive treatment for transplant or other diseases associated with high mortality; stage iv cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with gfr less than 30; chf new york heart association class iii or iv, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe covid-19 respiratory failure myocardial infarction in previous six months or troponin >0.5 recent history of venous thrombotic events (pe / dvt) within the last 3 months. new diagnosis of atrial fibrillation within the last 3 months. acceptable if greater than 3 months and well controlled in the opinion of the investigator watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes pregnancy

2

APR Applied Pharma Research s.a.

18

85

None

Severe disease at enrollment

6: Severe disease at enrollment

0

Progression to Respiratory Failure

None

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"}]