NCT04360096 - Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 | Biotech Hunter

Enrollment

144

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

December 15, 2021

Study Completion Date

December 31, 2021

Conditions

SARS-CoV 2COVIDARDSALIAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Dyspnea

Interventions

DRUG

ZYESAMI™ (aviptadil acetate)

Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer

DRUG

Placebo

Normal Saline Inhalation

DEVICE

Nebulized administration of ZYESAMI™ or Placebo

Use of 510(k) cleared mesh nebulizer to deliver investigational product

Trial Locations (13)

18901

Doylestown Hospital, Doylestown

29646

Self Regional Healthcare, Greenwood

32803

Advent Health Research Institute, Orlando

33136

University of Miami Leonard M. Miller School of Medicine (UMMSM), Miami

40202

University of Louisville Hospital, Louisville

45429

Kettering Health Network, Kettering

60190

Northwestern Medical Group, Winfield

69101

Great Plains Health, North Platte

78229

University of Texas San Antonio Medical Arts and Research Center, San Antonio

89102

University Medical Center, Las Vegas

92697

University of California - Irvine, Irvine

92835

St. Jude Medical Center, Fullerton

07666

Holy Name Medical Center, Teaneck