COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04843787

Julia Ortega

jortega@selvarx.com

2021-04-14

Not recruiting

RCT

Randomized

Sequential assignment

Blind label

unclear

Treatment

inclusion criteria: agree to participate in the trial by signing the irb approved informed consent age ≥ 18 years of age positive diagnosis for covid-19 by sars-cov-2 pcr by nasopharyngeal swab within the past 3 days two or more covid-19 symptoms (at least one of which must be respiratory) rated mild or moderate on the covid-19 adapted flu-pro plus scale spo2 ≥ 94% ambulatory (not hospitalized) at the time of enrollment normal (or stable if abnormal per comorbidity) baseline ecg men of child-bearing potential must use birth control with heterosexual partner(s) (abstinence or condoms) women of child-bearing potential must meet all the following criteria: use of birth control (abstinence, oral contraceptives, condoms, or intrauterine device) test negative for β-subunit of hcg

pregnant or lactating treatment with covid-19 antiviral such as remdesivir or sars-cov-2 antibodies at increased risk of developing more severe covid-19 disease (at least one of the following): age ≥60 years presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema diabetes mellitus (type 1 or 2), requiring oral medication or insulin for treatment cardiovascular disease, including hypertension, requiring at least 1 oral medication for treatment; congestive heart failure; coronary artery disease; cardiomyopathy; pulmonary hypertension body mass index ≥30 chronic renal disease (but not on dialysis) sickle cell disease or trait severe or critical covid-19, as indicated by respiratory distress or shortness of breath at rest; resp rate ≥30/min; heart rate ≥125/min; spo2 ≤ 93% on room air or pao2/fio2 ≤ 300 if on supplemental o2 positive hiv or positive hepatitis panel treatment with any medications known to be strongly metabolized by cyp3a4 or cyp2d6

5

Kenneth Krantz, MD, PhD

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

81

Treatment-Emergent Adverse Events

None

Phase 2

[{"arm_notes": "200 mg BID", "treatment_id": 1208, "treatment_name": "Slv213", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "400 mg BID", "treatment_id": 1208, "treatment_name": "Slv213", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "800 mg QD", "treatment_id": 1208, "treatment_name": "Slv213", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "maximum tolerated dose", "treatment_id": 1208, "treatment_name": "Slv213", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]