COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04583592

Atasi Jana, M.D.

ajana@sagentpharma.com

2020-10-12

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: adults willing and able to provide informed consent before performing study procedures adults ≥18 years of age at time of informed consent participants must have written notification of laboratory confirmed covid-19 infection performed prior to screening, at a local laboratory by rt-pcr or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed covid-19 have a mild or moderate form of covid-19 defined as spo2 > 94% at screening participants must have at least 1 of the following risk factors for severe illness aged 65 years or older hypertension diabetes mellitus chronic lung disease including asthma, chronic obstructive pulmonary disease (copd), and interstitial lung disease (eg, idiopathic pulmonary fibrosis) chronic cardiac conditions, including coronary artery disease (cad), heart failure, congenital heart disease, cardiomyopathy severe obesity (body mass index [bmi] ≥ 40 kg/m^2) chronic liver disease, including cirrhosis must agree not to enroll in another study of an investigational agent or take any other drug that has been granted emergency use authorization prior to completion of day 28 if women of childbearing potential (wocbp) or men whose sexual partners are wocbp, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug

physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely known severe liver disease (eg, child pugh score > 12, ast >5 times upper limit) sao2/spo2 ≤94% on room air condition, or the pa02/fi02 ratio < 300 mghg known allergic reaction to camostat mesilate or one of its excipients known severe renal impairment (estimated glomerular filtration rate ≤30 ml/min/1.73 m^2) or receiving dialysis pregnant or breastfeeding, or positive pregnancy test in a predose examination receipt of any experimental treatment for covid-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. no off label use of a drug for covid 19 is allowed. history of human immunodeficiency virus infection on highly active antiretroviral therapy (haart)

2

Sagent Pharmaceuticals Inc.

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

295

Disease Progression at Day 28

None

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 245, "treatment_name": "Camostat mesilate", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]