Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19

STATUS

Recruiting
participants needed

24
sponsor

Clear Creek Bio, Inc.

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Updated on 19 February 2024

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fever

pao2

FIO2

dyspnea

PCR test

cough

headache

pharyngitis

covid-19

gastrointestinal symptoms

malaise

myalgia

SARS

sore throat

coronavirus infection

fraction of inspired oxygen (fio2)

throat

acute respiratory syndrome (sars)

Summary

This will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for treatment of hospitalized patients with COVID-19 infection. In addition to SOC, the brequinar group will receive 5 daily doses of brequinar 100 mg.

Description

This will be a phase 1a randomized, open label, multi-center study with approximately 24 subjects. All subjects will receive standard of care (SOC) per institutional guidelines for SARS-CoV-2 infection. Subjects will be randomly assigned in a 1:2 ratio to standard of care alone or standard of care plus brequinar. The brequinar group will receive 5 daily doses of brequinar 100 mg on Days 1 - 5. Physical examinations, vital signs, laboratory assessments, SARS-CoV-2 testing, and other observations will be conducted by experienced personnel throughout the study based on the Schedule of Events. Blood chemistry tests include blood urea nitrogen (BUN), creatinine, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), bilirubin, total protein, albumin, glucose, serum electrolytes (sodium, potassium, chloride, carbon dioxide/bicarbonate, and calcium), lactate dehydrogenase (LDH). Plasma will be collected for inflammatory markers such as D-dimer, ferritin, CRP, and ESR. Pro-inflammatory markers will be measured. Serum is to be collected for research purposes. Hematology tests include hemoglobin, hematocrit, complete blood count with full differential, and platelet count. Nasopharyngeal swabs for viral load will be collected Days 1, 3, 5, 7, and 15. Survival will be assessed through Day 29.

Details

Condition	Covid 19
Age	18-100 years
Treatment	Standard of Care, Brequinar
Clinical Study Identifier	NCT04425252
Sponsor	Clear Creek Bio, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'Willing and able to provide informed consent for the trial, written, electronic,'
	b'verbal or other method deemed acceptable by the institution and IRB.'
	b'18 years of age or older.'
	b'If discharged from the hospital prior to Study Day 15 or if follow up is needed for'
	b'tudy drug-related adverse event, willing to go to an outpatient laboratory for a'
	b'laboratory sample as well as a contact (phone call or other digital media) on Study'
	b'Days 7 and 15 and contact only on Day 29.'
	b'Laboratory-confirmed SARS-CoV-2 infection as determined by real time polymerase chain'
	b'reaction (RT-PCR) or other FDA-cleared commercial or public health assay.'
	b'Hospitalized (in patient with expected duration \\u2265 24 hours)'
	b'The effects of brequinar on the developing human fetus are unknown. For this reason,'
	b'women of child-bearing potential and men must agree to use adequate contraception'
	b'(hormonal or barrier method of birth control; abstinence) prior to study entry and for'
	b'the duration of study participation. Should a woman become pregnant or suspect she is'
	b'pregnant while she or her partner is participating in this study, she should inform'
	b'her treating physician immediately. Men and women treated or enrolled on this protocol'
	b'must also agree to use adequate contraception for the duration of study participation,'
	b'and for 90 days after completion of brequinar administration.'
	b'Male subjects must agree to refrain from sperm donation from initial study drug'
	b'administration until 90 days after the last dose of brequinar.'
	b'\\u2264 10 days since first COVID-19 symptom as determined by treating clinician.'
	b'COVID-19 symptoms of severity mild (fever, cough, sore throat, malaise, headache,'
	b'muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea),'
	b'moderate (any symptom of mild illness or shortness of breath with exertion), or severe'
	b'(any symptom of moderate illness or shortness of breath at rest, or respiratory'
	b'distress).'
	b'COVID-19 signs of severity mild (no clinical signs), moderate (respiratory rate \\u2265 20'
	b'breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart'
	b'rate \\u2265 90 beats per minute) or severe (respiratory rate \\u2265 30 per minute, heart rate \\u2265'
	b'125 per minute, SpO2 \\u2264 93% on room air at sea level or PaO2/FiO2 < 300)'
Exclusion Criteria
	b'Any physical examination findings and/or history of any illness that, in the opinion'
	b'of the study investigator, might confound the results of the study or pose an'
	b'additional risk to the patient'
	b'Active malignancy other than squamous cell carcinoma; anticancer treatment such as'
	b'chemotherapy or radiation therapy within the past month.'
	b'Nursing women or women of childbearing potential (WOCBP) with a positive pregnancy'
	b'test.'
	b'Treatment with another DHODH inhibitor (e.g., leflunomide, teriflunomide), tacrolimus,'
	b'irolimus.'
	b'Platelets \\u2264150,000 cell/mm3.'
	b'Hemoglobin < 12 gm/dL'
	b'Absolute neutrophil count < 1500 cells/mm3'
	b'Renal dysfunction, i.e., creatinine clearance < 50 mL/min'
	b'AST and/or ALT > 1.5 ULN, or total bilirubin > ULN'
	b'History of bleeding disorders or recent surgery in the six weeks preceding enrollment'
	b'Concomitant use of agents known to cause bone marrow suppression leading to'
	b'thrombocytopenia'
	b'History of gastrointestinal ulcer, or history of gastrointestinal bleeding.'
	b'History of hepatitis B and/or C infection, active liver disease and/or cirrhosis.'
	b'Heart failure, current uncontrolled cardiovascular disease, including unstable angina,'
	b'uncontrolled arrhythmias, major adverse cardiac event within 6 months (e.g. stroke,'
	b'myocardial infarction, hospitalization due to heart failure, or revascularization'
	b'procedure).'
	b'Baseline COVID-19 severity characterized as "Critical" based on the FDA Guidance'
	b'"COVID-19: Developing Drugs and Biological Products for the Treatment or Prevention"'
	b'(https://www.fda.gov/media/137926/download). Evidence of critical illness defined by'
	b'at least one of the following:'
	b'Respiratory failure based on resource utilization requiring at least one of the'
	b'following:'
	b'Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow'
	b'nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula'
	b'at flow rates > 20 L/min with fraction of delivered oxygen \\u2265 0.5), noninvasive'
	b'positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure'
	b'(i.e., clinical need for one of the preceding therapies, but preceding therapies'
	b'may not be able to be administered in setting of resource limitation)'
	b'Shock (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure'
	b'< 60 mm Hg or requiring vasopressors)'
	b'Multi-organ dysfunction/failure.'

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Safety and Anti-coronavirus Response of Suppression of Host Nucleotide Synthesis in Patients With COVID-19