COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04354259

Shinthuka Jeganathan, MBBS

shinthuka.jeganathan@uhn.ca

2020-04-21

Unknown

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

cohort a - ambulatory inclusion criteria adult patients between the ages of 18 and 75 years. confirmed covid-19 infection by pcr within 7 days of symptom onset (fever, respiratory symptoms, sore throat). discharged to home isolation. willing and able to sign informed consent. willing and able to follow-up by daily phone or videoconference. female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. adequate methods of contraception are: a. for female patients i. hormonal contraceptives including progestogen injection (eg, depo-provera®), combined oral contraceptive pill or vaginal ring for ≥ 3 months before screening and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. intrauterine device (iud) or intrauterine system (ius) in place ≥ 3 months before screening and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iii. surgical sterilization of the partner (vasectomy ≥ 1 month before screening) and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iv. double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening. b. for male patients i. surgical sterilization (vasectomy ≥ 1 month before screening) and a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. consistently and correctly use a condom from screening and female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper iud), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide). exclusion criteria requirement for hospital admission current immunosuppression due to medication (steroids, biologics, chemotherapy) or underlying condition such as organ/bone marrow transplant or untreated hiv or hiv infection with detectable hiv rna and/or cd4 count of <500. pregnancy (or positive urine pregnancy test) or lactating the following pre-existing medical conditions: known seizure disorder known retinal disease requiring therapy known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease) known history of chronic obstructive pulmonary disease (copd) or asthma associated with functional impairment known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy) known chronic kidney disease with estimated creatinine clearance < 50 ml/minute or need for dialysis severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda advanced cancer or other illness with life expectancy of < 1 year known alcohol or drug dependence that in the opinion of the investigator would impair study participation known prior intolerance to interferon treatment enrolment in another clinical trial with use of any investigational agent in the prior 30 days use of off-label therapy for covid-19 cohort b - hospitalized inclusion criteria adult patients over age 18 sars-cov-2 rna-positive on nasopharyngeal swab/respiratory specimen within 10 days of symptom onset admitted to hospital for management of covid-19 willing and able to provide informed consent female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal. adequate methods of contraception are: a. for female patients: i. hormonal contraceptives including progestogen injection (eg, depo-provera®), combined oral contraceptive pill or vaginal ring for ≥ 3 months before screening and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. intrauterine device (iud) or intrauterine system (ius) in place ≥ 3 months before screening and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iii. surgical sterilization of the partner (vasectomy ≥ 1 month before screening) and a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or iv. double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening. b. for male patients: i. surgical sterilization (vasectomy ≥ 1 month before screening) and a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or ii. consistently and correctly use a condom from screening and female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper iud), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide). exclusion criteria severity of illness respiratory failure (requiring>6l o2 or intubation in the er) shock - systolic bp<90 mmhg or mean arterial bp<60 mmhg after fluid resuscitation current immunosuppression due to medication (steroids, biologics, chemotherapy) or underlying condition such as organ/bone marrow transplant or untreated hiv or hiv infection with detectable hiv rna and/or cd4 count of <500. pregnancy (or positive urine pregnancy test) or lactating the following pre-existing medical conditions: known seizure disorder known retinal disease requiring therapy known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (rheumatoid arthritis, lupus, inflammatory bowel disease) known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy) known chronic kidney disease with estimated creatinine clearance < 30 ml/minute or need for dialysis severe psychiatric disorder - uncontrolled schizophrenia, bipolar disorder, depression with prior suicidality any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda known prior intolerance to interferon treatment enrolment in another clinical trial with use of an antiviral agent in the prior 30 days (co-enrollment with immunomodulatory agents permitted) use of off-label therapy for covid-19 any of the following abnormal laboratory indices hemoglobin < 100 mg/dl platelet count < 75,000 cells/mm3 absolute neutrophil count < 1,000 cells/mm3 estimated creatinine clearance < 30 cc/ml total bilirubin > 2x upper limit of normal (uln) alanine aminotransferase (alt) > 5x uln aspartate aminotransferase (ast) > 5x uln lipase or amylase > 2x uln random blood glucose > 20 mmol/l

None

3

University Health Network, Toronto

18

None

Brazil;Canada

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

240

Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint);Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint);Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint);Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)

None

Phase 2

[{"arm_notes": "Cohort A - Ambulatory and Cohort B - Hospitalized", "treatment_id": 674, "treatment_name": "Interferon lambda", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort A - Ambulatory and Cohort B - Hospitalized", "treatment_id": 674, "treatment_name": "Interferon lambda", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]