SARS CoV 2 infection in outpatients MedDRA version: 23.0 Level: PT Classification code 10084271 Term: SARS-CoV-2 test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Code: CT-P59
Pharmaceutical Form: Solution for infusion
Other descriptive name: CT-P59
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 40-
Pharm
Sponsors
Celltrion, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following criteria to be randomized in this study. 1. Adult male or female patient, aged a. >60 years, or b. =18 and =60 years, and having any baseline comorbidities which are known as the risk factors for deterioration to severe SARS-CoV-2 infection (cardiovascular disease, chronic respiratory disease, hypertension, or diabetes mellitus) 2.Patient is diagnosed with SARS-CoV-2 infection at Screening by using the RT-PCR. Note: If the patient had a RT-PCR result (within 72 hours prior to the study drug administration) confirming SARS-CoV-2 infection even if before signing the ICF, the patient can be enrolled without additional confirmation of SARS-CoV-2 infection at Screening. Note: During the Screening Period, only one re-test for confirmation of SARS-CoV-2 infection will be allowed, if study drug can be administered no more than 7 days from onset of symptom based on the re-test result. 3.Patient with conditions meeting all of the following criteria: a.Oxygen saturation > 94% on room air. b.Not requiring supplemental oxygen. Note: Patient with clinical signs of pneumonia but no signs of severe pneumonia (as defined in the World Health Organization Guidance, 2020) at the investigator’s discretion is eligible for this study. 4.Patient whose onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one SARS-CoV-2 infection associated symptom. 5.Patient has one or more of the following (but not limited to) SARS-CoV-2 infection associated symptoms within but not more than 7 days prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache Chills Nasal obstruction or congestion Loss of taste or smell Nausea or vomiting Diarrhea 6.Patient has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache 7.Patient (or legal guardian, if applicable) who is informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the ICF prior to participation in the study. 8.For both male and female patients, the patient and his or her partner of childbearing potential who agree to use a highly effective or medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug as specified below: Combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation Intrauterine devices True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence of the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. Condom in addition to use spermicide, hormonal contraceptive or barrier method in female; for male patient with his female partner of childbearing potential only. Spermicide condom (condoms coated with spermicide) use alone is not allowed. Male and female patients and their partners who have
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1.Patient with current serious condition meeting one of the following criteria: a.Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization. Guidance, 2020). b.Respiratory distress with respiratory rate = 30 breaths/min. c.Requires supplemental oxygen. d.Experience shock. e.Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion. 2.Patient who has received or has a plan to receive any of following prohibited medications or treatments: a.Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (or alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus (HIV) protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration. b.Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration. c.Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration. d.Use of medications that are contraindicated with SoC. e.SARS-CoV-2 vaccine prior to the study drug administration. 3.Patient has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug. 4.Patient who has a current or history of any of the following infections: a.Any active infection other than SARS-CoV-2 requiring systemic treatment. b. Documented current infection with HIV, hepatitis B or hepatitis C. c.Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization. 5.Patient who has a medical condition including one or more of the following at Screening: a.Any uncontrolled clinically significant respiratory disease in the investigator’s opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma). b.Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase =5 × upper limit normal c.Renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis. d.History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study drug administration. e.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study. f.Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator. g.Any active malignancy. h.Currently immunocompromised, whether due to underlying medical condition (e.g., malignancy, transplantation) or medical therapy (e.g., medications, chemotherapy, radiation). i.Any co-morbidity req
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective (Part 1) To assess the potential therapeutic efficacy of CT-P59 as determined by time to negative conversion in nasopharyngeal swab specimen based on reverse transcription quantitative polymerase chain reaction (RT-qPCR) or cell culture up to Day 14 Primary Objective (Part 2) To demonstrate the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 ;Secondary Objective: Key Secondary Objectives (Part 1) - To assess the potential therapeutic efficacy of CT-P59 as determined by proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit up to Day 14 - To assess the potential therapeutic efficacy of CT-P59 as determined by time to clinical recovery up to Day 14 - To assess the clinically meaningful therapeutic efficacy of CT-P59 as determined by proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28 Secondary Objectives (Part 1 and Part 2) To evaluate the additional efficacy of CT-P59 To evaluate overall safety of CT-P59, including immunogenicity and potential effects on the incidence of ADE;Primary end point(s): For Part 1, the primary endpoint is defined as: Time to negative conversion in nasopharyngeal swab specimen based on RTqPCR or cell culture up to Day 14 For Part 2, the primary endpoint is defined as: Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28. Key Secondary Endpoints The following key secondary endpoints will be analyzed for Part 1. •Proportion of patient with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit up to Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints The following secondary endpoints will be analyzed for both Part 1 and Part 2 throughout the study. Efficacy The following secondary efficacy endpoints will be assessed up to Day 14 and up to Day 28. •Proportion of patients requiring supplemental oxygen due to SARS-CoV-2 infection •Proportion of patients with intensive care unit transfer due to SARS-CoV-2 infection •Proportion of patients with all-cause mortality •Time to clinical recovery •Duration of fever defined as the last day in the patient diary on which the temperature > 38°C (100.4°F) is recorded, or a potentially antipyretic drug (acetaminophen or ibuprofen) is taken •Proportion of patients with hospital admission due to SARS-CoV-2 infection - Proportion of mechanical ventilation due to SARS-CoV-2 infection - Proportion of patients requiring rescue therapy due to SARS-CoV-2 infection - Proportion of patients with negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture at each visit - Time to negative conversion in nasopharyngeal swab specimen based on RT-qPCR or cell culture - Time to NEWS2 of 0 - Scores of other known SARS-CoV-2 infection symptoms such as vomiting, diarrhea, loss of taste or smell Rescue therapy is defined as the prohibited medication administered due to SARS-CoV-2 infection after the study drug administration on Day 1. Safety Safety assessments will occur throughout the study. The following safety parameters are determined as secondary safety endpoints: •Adverse events (including SAEs) •Adverse events of special interest (Infusion related reactions [hypersensitivity/ anaphylactic reactions]) •Potential effects on the incidence of ADE •Immunogenicity •Vital sign measurements (blood pressure, heart rate, respiratory rate, SpO2 and body temperature), weight and BMI •Hypersensitivity monitoring •12-lead electrocardiogram •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection related signs and | — |
Countries
Brazil, Hungary, India, Ireland, Italy, Korea, Republic of, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United States
Contacts
Public ContactSung Hyun Kim
CELLTRION, Inc.
Outcome results
None listed