COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04481685

Kimberly Lovell

klovell@kumc.edu

2020-07-22

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - able to comprehend and be willing to sign the institutional review board (irb)-approved subject informed consent form (icf) prior to administration of any study-related procedures, or consent from surrogate decision maker when the above criteria cannot be met - male or non-pregnant female adult ≥18 years of age at time of enrollment; female patients must have a negative serum pregnancy test at study enrollment - has laboratory-confirmed covid-19 coronavirus infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in oropharyngeal or nasopharyngeal testing within 14 days of hospitalization. an additional 24-hour covid-19 pcr test will be performed at kumc. patients outside of kumc will have their samples sent to kumc as a central lab for test processing - hospitalized as a result of symptoms and signs related to covid-19 infection, and ≤14 days since positive test - evidence of hypoxic respiratory failure: spo2≤93% on room air, or spo2 >93% requiring ≥ 2 liters (l) o2, or pa02/fi02 ratio <300 millimeter of mercury (mmhg), or tachypnea (respiratory rate > 30 breaths/min) - evidence of pulmonary involvement by: chest imaging or pulmonary exam - previous use of hydroxychloroquine or chloroquine is allowed in this study - adequate organ function per laboratory tests - females of child-bearing potential and males with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in child-bearing potential/pregnancy section for the duration of study participation and for 30 days for females and 90 days for males following completion of therapy

- known hypersensitivity to ati-450 - history or evidence of active or latent tuberculosis or recent exposure (within last 30d) to a person with active tb - evidence of active, untreated bacterial infection. patients who are treated with antibiotics for at least 72 hours, will become eligible for rescreening for trial enrollment - active use of immunosuppressant medication(s) (i.e. anti-rejection ,immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents and janus kinase (jak) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization. (use of hydroxychloroquine/chloroquine should be discontinued) - oncology patients who are on active chemotherapy or immunotherapy. however, oncology patients who come off active therapy prior to enrollment and have absolute neutrophil count (anc) ≥1500/mmc are eligible for enrollment - active participation in a concurrent covid-19 clinical trial with investigative medical drug therapies. however, co-enrollment for non-investigative drug therapies will be allowed; use or re-purposing of fda approved treatments will be considered at the discretion of the medical monitor - in the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours - pregnancy or breast feeding - prisoner - intubation and ventilation at time of enrollment - known history for hiv, hepatitis b or c infection. patients with serologic evidence of hepatitis b vaccination (hepatitis b surface antibody without the presence of hepatitis b surface antigen) will be allowed to participate - history of a past or current medical condition that in the opinion of the treating physician would compromise patient safety (e.g. uncontrolled hiv) by participation in the study

2

University of Kansas Medical Center

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

20

Respiratory failure-free survival in participants with moderate-severe COVID-19 who are treated with ATI-450

None

Phase 2

[{"arm_notes": "", "treatment_id": 136, "treatment_name": "Ati-450", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]