protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04332991 | 5 | OUTCOMES | 5. OUTCOMES | [] |
NCT04332991 | 5.1 | Primary Outcome | 5.1 Primary Outcome COVID Ordinal Outcomes Scale on Study Day 15: - 1. Death - 2. Hospitalized on invasive mechanical ventilation or ECMO - 3. Hospitalized on non-invasive ventilation or high flow nasal cannula - 4. Hospitalized on supplemental oxygen - 5. Hospitalized not on supplemental oxygen - 6. Not hospitalized w... | [] |
NCT04332991 | 5.2 | Secondary Outcomes | 5.2 Secondary Outcomes - Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge - All-location, all-cause 14-day mortality (assessed on Study Day 15) - All-location, all-cause 28-day ... | [] |
NCT04332991 | 5.3 | Safety outcomes | 5.3 Safety outcomes - Seizure - Atrial or ventricular arrhythmia - Cardiac arrest - Elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal - Acute pancreatitis - Acute kidney injury - Receipt of renal replacement therapy - Symptomatic hypoglycemia - Neutropenia, lym... | [] |
NCT04332991 | 5.4 | Rationale for Primary Outcome | 5.4 Rationale for Primary Outcome COVID-19 has a broad spectrum of clinical severity. Even among hospitalized patients, most recover without experiencing critical illness.30 Designing a trial with statistical power to detect a meaningful difference in ICU-free days or mortality might require an unfeasibly large sample ... | [] |
NCT04332991 | 6 | DATA COLLECTION | 6. DATA COLLECTION Given the infectious risk from COVID-19 and potential shortages of personal protective equipment (PPE), we will minimize face-to-face contact between patients and non-clinical staff. Additionally, minimizing research activities and conducting the trial in a pragmatic manner will increase the ability ... | [] |
NCT04332991 | 6.1 | Baseline Variable Collection | 6.1 Baseline Variable Collection - Presence or absence of inclusion and exclusion criteria - Date and time of randomization - Date of symptom onset - Admission data: date and time of presentation, origin (home, skilled nursing facility, rehabilitation/LTACH, nursing home, outside hospital, outside ICU), location at enr... | [] |
NCT04332991 | 6.2 | Assessments between Hospital Presentation and Hospital Discharge | 6.2 Assessments between Hospital Presentation and Hospital Discharge - Specimen type, date, and result of SARS-CoV-2 testing conducted clinically - Specimen type, date, and result of viral testing conducted clinically - Specimen type, date, and result of bacterial testing conducted clinically - Date and time of study d... | [] |
NCT04332991 | 6.3 | Assessments following Hospital Discharge | 6.3 Assessments following Hospital Discharge | [] |
NCT04332991 | 6.3.1 | Acute Care Follow-up | 6.3.1 Acute Care Follow-up For participants discharged from the study hospital prior to the Day 8, Day 15 or Day 29 assessment, we will perform these assessments via telephone follow-up. The Day 8 call window will be Day 8 through 14. The Day 15 call window will be Day 15 through 22. The Day 29 call window will be Day ... | [] |
NCT04332991 | 6.3.2 | Long-term Follow-up | 6.3.2 Long-term Follow-up We will follow-up selected patients at 3, 6, and 12 months to assess vital status, cognition, basic and instrumental activities of daily living, quality of life, employment status, physical disability, and psychological distress (i.e., depression, post-traumatic stress disorder, etc.), place o... | [] |
NCT04332991 | 7 | STATISTICAL CONSIDERATIONS | 7. STATISTICAL CONSIDERATIONS | [] |
NCT04332991 | 7.1 | Statistical Approach | 7.1 Statistical Approach The primary analysis will be an intention-to-treat comparison of the Day 15 COVID Ordinal Outcome score between patients randomized to hydroxychloroquine versus placebo. This analysis will be conducted with a proportional odds model using the Day 15 COVID Ordinal Outcome score as the dependent ... | [
"FIGURE 1",
"FIGURE 2"
] |
NCT04332991 | 7.2 | Planned deviations from this design | 7.2 Planned deviations from this design This trial is being conducted in a rapidly evolving pandemic of a novel disease. Thus, we have developed a statistical plan with flexibility to be modified based on results from other concurrently conducted trials and emerging data on the clinical epidemiology of COVID-19. The pr... | [] |
NCT04332991 | 8 | DATA QUALITY MONITORING AND STORAGE | 8. DATA QUALITY MONITORING AND STORAGE | [] |
NCT04332991 | 8.1 | Data Quality Monitoring | 8.1 Data Quality Monitoring Data quality will be reviewed remotely using front-end range and logic checks at the time of data entry and back-end monitoring of data using application programming interface tools connecting the online database to statistical software to generate data reports. Patient records and case repo... | [] |
NCT04332991 | 8.2 | Data Storage | 8.2 Data Storage Data will be entered into a secure online database. All data will be maintained in the secure online database until the time of study publication. At the time of publication, a de-identified version of the database will be generated. | [] |
NCT04332991 | 9 | RISK ASSESSMENT | 9. RISK ASSESSMENT | [] |
NCT04332991 | 9.1 | Potential Risk to Participants | 9.1 Potential Risk to Participants Although hydroxychloroquine is an FDA approved medication with an established safety profile (described as "among the safest medications used for the treatment of systematic rheumatic disease"),38 potential risks exist to participating in this study of hydroxychloroquine versus placeb... | [] |
NCT04332991 | 9.1.1 | Potential risks of receiving hydroxychloroquine | 9.1.1 Potential risks of receiving hydroxychloroquine Potential risks of receiving hydroxychloroquine can be classified based on their severity as Major or Minor. Major potential risks of receiving hydroxychloroquine include:
1) Neurological System - a) Seizure Hydroxychloroquine can lower the seizure threshold and co... | [
"1) Neurological System",
"2) Circulatory system",
"3) Digestive system",
"4) Endocrine system",
"5) Integumentary system",
"6) Hematological system"
] |
NCT04332991 | 9.1.2 | Potential risks of receiving placebo with COVID-19 | 9.1.2 Potential risks of receiving placebo with COVID-19 One potential risk to participating in this study is receiving placebo rather than hydroxychloroquine. This risk is only relevant if hydroxychloroquine is ultimately found to be an effective therapy for COVID-19 and is not relevant if hydroxychloroquine is ultima... | [] |
NCT04332991 | 9.1.3 | Potential risks of receiving an EKG. | 9.1.3 Potential risks of receiving an EKG. EKGs are a safe, noninvasive, painless test and have no major risks. Patients may develop a mild rash or skin irritation where the electrodes were attached. If any paste or gel was used to attach the electrodes, patients may have an allergic reaction to it. This irritation usu... | [] |
NCT04332991 | 9.2 | Minimization of Risk | 9.2 Minimization of Risk Federal regulations at 45 CFR 46.111(a)(1) require that risks to participants are minimized by using procedures which are consistent with sound research design. This trial protocol incorporates numerous design elements to minimize risk to patients that meet this human subject protection require... | [] |
NCT04332991 | 9.3 | Potential Benefit | 9.3 Potential Benefit Study participants may or may not receive any direct benefits from their participation in this study. Administration of hydroxychloroquine may improve clinical outcomes among adults hospitalized for COVID-19 infection. | [] |
NCT04332991 | 9.4 | Risk in Relation to Anticipated Benefit | 9.4 Risk in Relation to Anticipated Benefit Federal regulations at 45 CFR 46.111 (a)(2) require that "the risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result." Based on the preceding assessment of risks ... | [] |
NCT04332991 | 10 | HUMAN SUBJECTS PROTECTIONS | 10. HUMAN SUBJECTS PROTECTIONS Each study participant or a LAR must sign and date an informed consent form. Approval of the central institutional review board will be required before any participant is entered into the study. | [] |
NCT04332991 | 10.1 | Selection of Subjects | 10.1 Selection of Subjects Federal regulations at 45 CFR 46(a)(3) require the equitable selection of subjects. The emergency departments, hospital wards, and ICUs of participating sites will be screened to determine if any patient meets inclusion and exclusion criteria. Data that have been collected as part of the rout... | [] |
NCT04332991 | 10.2 | Justification of Including Vulnerable Subjects | 10.2 Justification of Including Vulnerable Subjects The present research aims to investigate the safety and efficacy of hydroxychloroquine for the treatment of patients with COVID-19 who are at high risk for respiratory failure and mortality. Due to the nature of this patient population, many of these patients will hav... | [] |
NCT04332991 | 10.3 | Informed Consent | 10.3 Informed Consent Federal regulations 45 CFR 46.111(a)(5) require that informed consent will be sought from each patient or the patient's LAR. Study personnel obtaining informed consent are responsible for ensuring that the patient or LAR understands the risks and benefits of participating in the study, answering a... | [] |
NCT04332991 | 10.4 | Continuing Consent | 10.4 Continuing Consent Patients for whom consent was initially obtained from a LAR, but who subsequently regain decisionmaking capacity while in hospital will be approached for consent for continuing participation, including continuance of data acquisition. The consent form signed by the LAR should reflect that such c... | [] |
NCT04332991 | 10.5 | Withdrawal of Consent | 10.5 Withdrawal of Consent Participating patients may withdraw or be withdrawn (by the LAR, treating physician, or investigator) from the trial at any time without prejudice. Data recorded up to the point of withdrawal will be included in the trial analysis, unless consent to use data has also been withdrawn. Withdrawa... | [] |
NCT04332991 | 10.6 | Identification of Legally Authorized Representatives | 10.6 Identification of Legally Authorized Representatives Many of the patients approached for participation in this research protocol will have impaired decisionmaking capacity due to critical illness and will not be able to provide informed consent. Accordingly, informed consent will be sought from the patient's LAR. ... | [] |
NCT04332991 | 10.7 | Justification of Surrogate Consent | 10.7 Justification of Surrogate Consent According to the Belmont Report, respect for persons incorporates at least two ethical convictions; first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. One method that serves to protect pati... | [] |
NCT04332991 | 10.8 | Additional Safeguards for Vulnerable Participants | 10.8 Additional Safeguards for Vulnerable Participants The present research will involve participants who might be vulnerable to coercion or undue influence. As required in 45CFR46.111(b), we recommend that sites utilize additional safeguards to protect the rights and welfare of these participants. Such safeguards migh... | [] |
NCT04332991 | 10.9 | Confidentiality | 10.9 Confidentiality Federal regulations at 45 CFR 46 111 (a) (7) requires that when appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data. At no time during the course of this study, its analysis, or its publication will patient identities be reve... | [] |
NCT04332991 | 11 | ADVERSE EVENTS | 11. ADVERSE EVENTS Assuring patient safety is an essential component of this protocol. Hydroxychloroquine has been approved by the Food and Drug Administration and used in clinical practice for decades with an established safety profile. Use of hydroxychloroquine for the treatment of acute respiratory infection due to ... | [] |
NCT04332991 | 11.1 | Adverse Event Definitions | 11.1 Adverse Event Definitions Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. Serious Adverse Event: A serious adverse event is any adverse event that results in one of the outcomes listed in section 11.3 below. Adverse Reac... | [] |
NCT04332991 | 11.2 | Safety Monitoring | 11.2 Safety Monitoring Assuring patient safety is an essential component of this protocol. Each participating investigator has primary responsibility for the safety of the individual participants under his or her care. The Investigators will determine daily if any adverse events occur during the period from enrollment ... | [] |
NCT04332991 | 11.3 | Serious Adverse Events | 11.3 Serious Adverse Events Serious adverse event collection begins after randomization and study procedures have been initiated. If a patient experiences a serious adverse event after consent, but prior to randomization or starting study procedures, the event will NOT be collected. Study site personnel must alert the ... | [] |
NCT04332991 | 12 | Data and Safety Monitoring Board (DSMB) | 12. Data and Safety Monitoring Board (DSMB) The principal role of the DSMB is to assure the safety of participants in the trial. They will regularly monitor data from this trial, review and assess the performance of its operations, and make recommendations to the steering committee and NHLBI with respect to: - Review o... | [] |
NCT04332991 | 13 | REFERENCES | 13. REFERENCES - 1. Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA 2020; - 2. Fauci AS, Lane HC, Redfield RR. Covid-19 Navigating the Uncharted. N Engl J Med 2020; - 3. Cao B, Wang Y, Wen D, et al. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med... | [] |
NCT04332991 | 14 | APPENDICES | 14. APPENDICES
Appendix A. Schedule of Events | Study Activity | Pre | Day | Day | Day | Day | Day | Day | Day | Day | 3 | 6 | 12 | |----------------------------------------------------|------------|-----|-----|-----|-----|-----|-----|-----|-----|--------|--------|--------| | | Enrollment | 1 | 2 | 3 | 4 | 5 | 8 | 15 ... | [
"Appendix A. Schedule of Events",
"Appendix B. Potential medication interactions with hydroxychloroquine",
"Appendix C: Adverse Event Reporting and Unanticipated Events",
"C.1. Unanticipated Problems (UP)",
"C.2. Determining Relationship of Adverse Events to Study Drug or Study Procedures",
"C.3. Clinical... |
NCT04354259 | 4.0 | Study Synopsis | 4.0 Study Synopsis | | Cohort A–Ambulatory | | | | | | | | | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Cohort B Inclusion Criteria",
"Cohort B Exclusion Criteria",
"Cohort B",
"Secondary Endpoints",
"Virologic/Immunological"
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NCT04354259 | 5.0 | Abbreviations & Definitions | 5.0 Abbreviations & Definitions AE – adverse events ALT – alanine aminotransferase AST – aspartate aminotransferase ASV – asunaprevir AUC – area under the curve Beta-hCG – beta human choriogonadotropin BP – blood pressure CI – confidence interval Co-I – co-investigator COPD – chronic obstructive pulmonary disease COVID... | [] |
NCT04354259 | 6.0 | Background/Rationale | 6.0 Background/Rationale SARS-CoV-2 is a novel coronavirus that has led to a global pandemic due to its relatively high transmissibility and potential to cause severe acute respiratory disease1 . There are currently no approved therapies for coronavirus disease-19 (COVID-19) and although various antiviral strategies ar... | [] |
NCT04354259 | 7.0 | Study Outline | 7.0 Study Outline 7.1 Hypothesis: Treatment with peginterferon lambda 180µg SC in patients with mild to moderate COVID-19 will accelerate viral clearance compared to best supportive care. | [] |
NCT04354259 | 7.2 | Objectives | 7.2 Objectives
Cohort A - Ambulatory - 1. To evaluate the safety and tolerability of immediate treatment with Peginterferon Lambda 180 mcg in patients with mild to moderate COVID-19 discharged to home isolation. - 2. To compare the proportion of individuals with a nasopharyngeal swab negative for SARS-CoV-2 RNA at day... | [
"Cohort A - Ambulatory",
"Cohort B - Hospitalized"
] |
NCT04354259 | 7.3 | Study Populations | 7.3 Study Populations The study population will include 2 cohorts and will follow an adaptive design with initial safety data in Cohort A guiding the initiation of Cohort B. | [] |
NCT04354259 | 7.4 | Study Design | 7.4 Study Design
Cohort A – Ambulatory Individuals who are seen at the assessment centre who are swabbed for possible COVID-19 and deemed well enough for home isolation will be informed about the study. They will be provided with contact information for the study team (email and phone number) and will contact the stud... | [
"Cohort A – Ambulatory",
"Cohort B – Hospitalized"
] |
NCT04354259 | 8.0 | Study Medication | 8.0 Study Medication | [] |
NCT04354259 | 8.1 | Peginterferon lambda overview | 8.1 Peginterferon lambda overview - Administered subcutaneously in the lower abdomen - Dose 180 µg SC weekly (in ambulatory arm of the study only 1 dose is given, which may last up to 1 week) - Composition: according to the manufacturer's specifications. - Expiry date: mentioned on the label or package. 8.2 Composition... | [] |
NCT04354259 | 8.3 | Use | 8.3 Use Peginterferon lambda is currently not approved for clinical use in Canada. Eiger BioPharmaceuticals, Inc (manufacturer) is providing the drug for study purposes. The syringes will be covered and dispensed from the study pharmacy at UHN to the participating hospitals and offsite clinic. | [] |
NCT04354259 | 8.4 | Mechanism of Action | 8.4 Mechanism of Action - Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. - Peginterferon lambda binds to the interferon lambda receptor expressed on epithelial cells in the lung, intestine, liver and skin and activates a signaling pathwa... | [] |
NCT04354259 | 8.5 | Contraindications | 8.5 Contraindications - Hypersensitivity to peginterferon lambda | [] |
NCT04354259 | 8.6 | Summary | 8.6 Summary As of 11-May-2018, approximately 3,743 subjects (including 237 healthy subjects; 3,276 subjects with HCV; and 197 subjects with HBV; and 33 subjects with HDV) have received peginterferon lambda or comparator in 19 Phase 1, 2, or 3 studies. Identified risks associated with treatment with peginterferon lambda... | [] |
NCT04354259 | 8.7 | Special Populations | 8.7 Special Populations Renal Impairment: The PK of peginterferon lambda in subjects with normal renal function or impaired renal function (IR) was measured in a total of 43 subjects (age 18–75 years, BMI 18–35 kg m–2) enrolled into one of 5 renal function groups: normal (n = 12), mild RI (n = 8), moderate RI (n = 8), ... | [] |
NCT04354259 | 8.9 | Clinical Trial Data | 8.9 Clinical Trial Data
Clinical Activity in Chronic HCV and HBV Infection The clinical activity of peginterferon lambda in combinations with direct-acting anti-viral agents is summarized in Table 8 The antiviral activity of peginterferon lambda against HCV was demonstrated in 2 Phase 2 studies investigating peginterf... | [
"Clinical Activity in Chronic HCV and HBV Infection"
] |
NCT04354259 | 8.10 | Summary of Safety | 8.10 Summary of Safety Peginterferon lambda has been generally well tolerated in clinical studies. A lower frequency of musculoskeletal (myalgia, arthralgia, and back pain) and flu-like symptoms (chills, pyrexia, and pain) was observed across Phase 2 studies in subjects receiving interferon regimens peginterferon lambd... | [] |
NCT04354259 | 8.11 | Pregnancy | 8.11 Pregnancy
Reproductive Risk Potential Peginterferon lambda has not been tested in pregnant or lactating women; however, in the embryofetal development study in pregnant mice, peginterferon lambda was determined to be a selective developmental toxicant with increased embryo mortality when administered at ≥ 0.02 mg... | [
"Reproductive Risk Potential"
] |
NCT04354259 | 8.12 | Placebo | 8.12 Placebo The placebo will be 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse. The syringes wi... | [] |
NCT04354259 | 9.0 | A. Cohort A – Ambulatory | 9.0 A. Cohort A – Ambulatory | [] |
NCT04354259 | 9 | 1 Inclusion/Exclusion Criteria | 9. 1 Inclusion/Exclusion Criteria
Inclusion Criteria - 1. Adult patients between the ages of 18 and 75 years. - 2. Confirmed COVID-19 infection by PCR within 7 days of symptom onset (fever, respiratory symptoms, sore throat). - 3. Discharged to home isolation. - 4. Willing and able to sign informed consent. - 5. Willi... | [
"Inclusion Criteria",
"b. For male patients",
"Exclusion Criteria"
] |
NCT04354259 | 9.2 | Study Procedures (Cohort A) | 9.2 Study Procedures (Cohort A) | [] |
NCT04354259 | 9.2.1 | Consent Process | 9.2.1 Consent Process Individuals at the COVID-19 assessment centres or emergency departments will be provided with information related to the study through study recruitment materials (posters) and instructed to contact study staff by email or telephone if they are interested in study participation. The study will als... | [] |
NCT04354259 | 9.2.2 | Enrolment and randomization | 9.2.2 Enrolment and randomization Those who test positive will be invited to attend the outpatient clinic for completion of screening, enrolment and randomization (see Standard Operating Procedures for Clinic Visits). Consenting individuals will undergo a medical history including current medication use and complete a ... | [] |
NCT04354259 | 9.2.3 | Study Interventions (See Schedule of Events – Ambulatory) | 9.2.3 Study Interventions (See Schedule of Events – Ambulatory) Those randomized to the peginterferon lambda arm will receive a single SC injection in the lower abdomen of peginterferon lambda 180µg and those randomized to placebo will receive a single SC injection of saline (and this will count as Day 0 of the study f... | [] |
NCT04354259 | 9.2.4 | Nasal Swabs and Saliva Collection | 9.2.4 Nasal Swabs and Saliva Collection The rationale for self-collection of mid-turbinate nasal swabs and saliva is to allow for more frequent sampling to determine the time of viral clearance and quantitative viral kinetics. Understanding how quickly individuals clear SARS-CoV-2 is very important for determining when... | [] |
NCT04354259 | 9.2.5 | Home Visits | 9.2.5 Home Visits For participants unable to travel to clinic visits, home visits by study staff will be provided as an alternative, provided participants live within a 30-minute drive of the site from which they were recruited and are agreeable to having study staff visit their home. Prior to home visits, study staff ... | [] |
NCT04354259 | 9.2.6 | Household contacts | 9.2.6 Household contacts For participants with household contacts, the coordinator will ask the participant to report a confirmed diagnosis of COVID-19 in any household contacts. Participants will be contacted at Days 14 and 30 to specifically ask if any household contacts have been diagnosed with COVID-19. | [] |
NCT04354259 | 9.2.7 | Participant Compensation | 9.2.7 Participant Compensation Participants will be reimbursed \$50 CAD for each of the study clinic visits (Day 0, 3, 7 and 14) for transportation and parking expenses. For the day 90+ visit, participants will be reimbursed \$100 for their time and costs associated with the visit. Any extra expenses incurred related t... | [] |
NCT04354259 | 9.2.8 | Standard Operating Procedures for Clinic Visits | 9.2.8 Standard Operating Procedures for Clinic Visits To ensure that clinic visits are carried out safely minimizing exposure to the public and study staff, the following procedures will be followed. Participants will be provided with hospital masks for themselves and their chauffeurs (if applicable) to be worn during ... | [] |
NCT04354259 | 9.2.9 | Safety Assessment | 9.2.9 Safety Assessment Peginterferon lambda has been given to >3,000 patients with chronic viral hepatitis for up to 48 weeks duration without major safety concerns, however, it has not been used in COVID-19 previously. We do not expect major safety concerns however, we will follow patients in the ambulatory arm close... | [] |
NCT04354259 | 9.3 | Outcomes (Cohort A) | 9.3 Outcomes (Cohort A)
Primary efficacy endpoint: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab at day 7.
Primary safety endpoint: Rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Secondary Endpoints:
Clinical - 1. Time to resolution of symptoms (f... | [
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"Primary safety endpoint:",
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"Transmission"
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NCT04354259 | 9.4 | Sample Size Calculation | 9.4 Sample Size Calculation
Cohort A Existing data from France and China were used to estimate the effect size. In a recent French study comparing chloroquine to no treatment, 2 of 16 (12.5%) untreated patients were SARS-CoV-2 negative at day 618. Although no studies have been performed with peginterferon lambda a sma... | [
"Cohort A",
"Rationale for Primary Endpoint Selection"
] |
NCT04354259 | 10 | B. Cohort B - Hospitalized | 10. B. Cohort B - Hospitalized | [] |
NCT04354259 | 10.1 | Safety Assessment | 10.1 Safety Assessment Prior to initiating screening for Cohort B, the Data Safety and Monitoring Committee (DSMC) will review data from Cohort A. They will review data after every 10 randomized participants Cohort A complete 7 days of follow-up until 50% of Cohort A has been recruited (n=30). After 50% of Cohort A has... | [] |
NCT04354259 | 10.2 | Inclusion/Exclusion Criteria | 10.2 Inclusion/Exclusion Criteria
Inclusion Criteria - 1. Adult patients over age 18 - 2. SARS-CoV-2 RNA-positive on nasopharyngeal swab/respiratory specimen within 10 days of symptom onset - 3. Admitted to hospital for management of COVID-19 - 4. Willing and able to provide informed consent - 5. Female patients of ch... | [
"Inclusion Criteria",
"b. For male patients:",
"Exclusion Criteria"
] |
NCT04354259 | 10.3 | Study Procedures (Cohort B) | 10.3 Study Procedures (Cohort B) | [] |
NCT04354259 | 10.3.1 | Consent Process | 10.3.1 Consent Process Potential participants meeting all inclusion and no exclusion criteria will be offered study enrolment. The study coordinator will explain the rationale and the risks and benefits of the study. A study investigator will be available to answer any questions related to the study. In addition to the... | [] |
NCT04354259 | 10.3.2 | Enrolment and randomization | 10.3.2 Enrolment and randomization Consenting individuals will undergo a medical history, focused physical examination, complete a symptom survey and have blood drawn for routine laboratory and inflammatory markers (if not already performed as standard of care). Female participants of childbearing potential will have a... | [] |
NCT04354259 | 10.3.3 | Study Interventions (See Schedule of Events – Hospitalized) | 10.3.3 Study Interventions (See Schedule of Events – Hospitalized) On Day 0, those randomized to the peginterferon-lambda arm will receive a SC injection in the lower abdomen of peginterferon lambda 180µg and those randomized to the placebo arm will receive a SC injection of saline. Participants will be seen on each st... | [
"Participant Compensation"
] |
NCT04354259 | 10.4 | Outcomes | 10.4 Outcomes
Cohort B
Primary efficacy endpoint: Clinical status on an ordinal scale at Day 14.
Primary safety endpoint: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Secondary Endpoints: - 1. Clinical status on an ordinal scale at Day 7, 21 and 28 - 2. ICU admission during hos... | [
"Cohort B",
"Primary efficacy endpoint:",
"Primary safety endpoint:",
"Secondary Endpoints:",
"Virologic/Immunological"
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NCT04354259 | 10.5 | Sample Size Calculation | 10.5 Sample Size Calculation The sample size was re-calculated based upon a change in the primary outcome to the score on an ordinal scale. Using the outcomes from the ORCHID trial evaluating the utility of hydroxychloroquine in hospitalized patients the following proportions at day 14 were identified; 6% died, 8% on i... | [] |
NCT04354259 | 10.6 | Rationale for Primary Endpoint Selection for Cohort B | 10.6 Rationale for Primary Endpoint Selection for Cohort B The clinical manifestations of COVID-19 are myriad, but the main symptom necessitating hospitalization is respiratory distress. An ordinal scale captures the spectrum of the clinical care received by an individual hospitalized with respiratory failure. Furtherm... | [] |
NCT04354259 | 11 | Optional Consents | 11. Optional Consents | [] |
NCT04354259 | 11.1 | Genetic Testing | 11.1 Genetic Testing A genome-wide association study (GWAS) performed on people treated with interferon-alpha therapy for hepatitis C virus (HCV) infection identified a single nucleotide polymorphism (SNP) near the interleukin 28B (IL28B) gene that was strongly associated with response to treatment22. Subsequent studie... | [] |
NCT04354259 | 11.2 | Peripheral Blood Mononuclear Cell (PBMC) | 11.2 Peripheral Blood Mononuclear Cell (PBMC) To evaluate SARS-CoV-2-specific immune responses, a subset (~30%) of participants in each cohort will be asked to consent to provide additional blood for PBMC isolation. Those who agree will have 5 tubes collected on Day 0, 3, 7 and 14 in Cohort A and Day 0, 1, and 14 in Co... | [] |
NCT04354259 | 11.3 | Antibody Testing | 11.3 Antibody Testing Currently there are three Health Canada approved testing platforms for antibodies against COVID-19. Although the clinical significance of the presence of IgM/IgG antibodies is not fully understood, the presence and quantity of anti-COVID-19 antibodies up to day 28 of the study to day 90+ visits wi... | [] |
NCT04354259 | 12 | Sample Processing | 12. Sample Processing | [] |
NCT04354259 | 12.1 | Swabs and Saliva | 12.1 Swabs and Saliva Collection of nasopharyngeal and mid-turbinate nasal will follow the instructions on the label of each specific swab. Immediately after the swab is completed, the swab should be placed in viral culture media. Saliva will be collected by filling one-third of sterile specimen container with spit. Se... | [] |
NCT04354259 | 12.2 | PBMC Collection | 12.2 PBMC Collection Samples for PBMCs will be transported to the laboratory of Dr. Adam Gehring for PBMC isolation, storage and downstream analysis using standard Ficoll PBMC isolation techniques following specific handling laid out by Infection Prevention and Control for UHN. | [] |
NCT04354259 | 13 | Study Withdrawal Study Discontinuation | 13. Study Withdrawal Study Discontinuation The investigator may advise the participant to withdraw from the study if there are concerns for participant safety. In Cohort B, if there are concerns that the participant's condition worsened after the first injection and it would not be safe to give a second injection, the ... | [
"Participant Withdrawal from the Study"
] |
NCT04354259 | 14 | Data Safety and Monitoring Committee (DSMC) | 14. Data Safety and Monitoring Committee (DSMC) To evaluate safety of this investigational agent, the Data Safety and Monitoring Committee (DSMC) of the Canadian HIV Clinical Trials Network (CTN) will be used. The DSMC consists of 6 members including a community member and follows an established charter. The DSMC will ... | [] |
NCT04354259 | 15 | Trial Oversight | 15. Trial Oversight A Steering Committee (SC) will consist of the overall study PIs, the site PI at each site, as well as study statistician. The SC will meet once weekly by teleconference for the first 4 weeks and then will adjust the frequency of meetings based on need. The DSMC will instruct the SC about continuatio... | [] |
NCT04354259 | 16 | Data Analysis | 16. Data Analysis The assessment of endpoints – both safety and efficacy – will be determined by study staff blinded to the treatment assignment of the participant. Descriptive statistics will be used to summarize demographic and clinical baseline characteristics of enrolled participants in Cohorts A and B. Continuous ... | [] |
NCT04354259 | 17 | Symptoms and AE/SAE Reporting | 17. Symptoms and AE/SAE Reporting
Symptom Score Symptoms will be collected by phone/videoconference. Participants will be asked about specific symptoms known to be common in COVID-19 or to be reported with interferon use. Symptoms will be rated as: none, mild, moderate or severe and will be compared to the day prior a... | [
"Symptom Score",
"1. Respiratory symptoms"
] |
NCT04354259 | 18 | Adverse Events and Serious Adverse Events | 18. Adverse Events and Serious Adverse Events An adverse event (AE) is any adverse change from the participant's baseline (pre-treatment) condition, including intercurrent illness which occurs during the course of the trial, after the consent form has been signed, whether the event is considered related to treatment or... | [] |
NCT04354259 | 19 | Ethical and Regulatory Considerations | 19. Ethical and Regulatory Considerations
Confidentiality Participant confidentiality will be maintained by generating a unique participant identification code that will be stored separately from the anonymized study database. Data relating to the study might be made available to third parties (for example in case of ... | [
"Confidentiality",
"Sources of Materials",
"Maintaining Records",
"Site Record Retention Policy",
"Informed Consent and Ethics Committee",
"Protocol Deviation"
] |
NCT04354259 | 20 | Schedule of Events | 20. Schedule of Events | [] |
NCT04354259 | 20.1 | Cohort A – Ambulatory | 20.1 Cohort A – Ambulatory | Group A - Ambulatory Cohort | Screening | Day 0 | Day 1 | Day 2 | Day 3 | Day 5 | Day 7 | Day 10 | Day 14 | Day 30 | Day 90+ | |----------------------------------------------------------------------------------------------------|-----------|-------|-------|-------|-------|-------|-------|--... | [] |
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