A PHASE 2/3, RANDOMIZED, PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CT-P59 IN COMBINATION WITH STANDARD OF CARE IN OUTPATIENTS WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS (SARS-COV-2) INFECTIO
- Conditions
- -B342 Coronavirus infection, unspecified siteCoronavirus infection, unspecified siteB342
- Registration Number
- PER-105-20
- Lead Sponsor
- CELLTRION, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1. Adult male or female patient, aged 18 or above. 2. Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or 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 who 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: a. Feeling feverish b. Cough c. Shortness of breath or difficulty breathing d. Sore throat e. Body pain or muscle pain f. Fatigue g. Headache h. Chills i. Nasal obstruction or congestion j. Loss of taste or smell k. Nausea or vomiting l. Diarrhea 6. Patient who has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration: a. Feeling feverish b. Cough c. Shortness of breath or difficulty breathing d. Sore throat e. Body pain or muscle pain f. Fatigue g. 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 informed consent form 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 been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any highly effective or medically acceptable methods of contraception. Meno
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 (alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus 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.
Note: During the study, in the event of progression of SARS-CoV-2 infection, rescue therapies using the prohibited medications are allowed based on the patient’s clinical disease status. Where treatments become SoC for the populations outlined in this study, the new SoC treatment will be added on to all of the treatment groups during the study. For SoC with a similar mechanism of action as the investigational agent (CT-P59), modifications to study design may be considered for Part 2 of this study.
3.Patient who 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.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 abno
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Checklist and direct evaluation of the patient with or without laboratory tests.<br>Measure:Efficacy Assessments:<br>Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28<br><br>Timepoints:Up to Day 28<br>
- Secondary Outcome Measures
Name Time Method