COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04668209

Not reported

Not reported

2020-12-16

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: male or non-pregnant female adult ≥ 18 years of age diagnosed/confirmed with covid-19 by standard rt-pcr assay or equivalent testing within 7 days prior to randomization (day1). hospitalized patient with severe illness caused by sars-cov-2 (note: prior or current use of remdesivir or dexamethasone (soc) are allowed under the investigator's discretion. concomitant treatment with other investigational antiviral drugs or immunomodulators are not permitted from day1 through day 28) symptoms of severe systemic illness/infection with covid-19: at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory infection including dyspnea at rest or respiratory distress and clinical signs indicative of severe systemic illness/infection with covid-19 at least 1 of the following: rr ≥ 30, hr ≥ 125, sao2 <93% on room air or requires > 2l oxygen by nasal cannula in order to maintain sao2 ≥93% patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. adequate hematopoietic capacity, as defined by the following: hemoglobin ≥ 9.0 g/dl and not transfusion dependent platelets ≥ 100,000/mm3 absolute neutrophil count ≥ 1500 cells/mm3 adequate hepatic function, as defined by the following: ast and alt ≤ 2.5 times upper limit of normal (uln) total bilirubin ≤ 1.5 x uln albumin ≥ 3.0 g/dl adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

patient showing signs of respiratory failure necessitating mechanical ventilation pregnant or nursing women. note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately. active or uncontrolled infections other than covid-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment active or planned concomitant treatment with other investigational antivirals or immunomodulators chronic diarrhea (excess of 2-3 stools/day above normal frequency) current use or anticipated need for drugs that are known strong inhibitors or inducers of major cyp enzymes.

2

University of Arizona

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

31

Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]

None

Phase 2

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