Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05679492
Status:
WITHDRAWN
Last Update Posted:
2023-09-15
First Post:
2023-01-10
Brief Title:
Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19
Sponsor:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Organization:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on current epidemic situation in China there is few Mild and Moderate COVID-19 patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled add-on Phase III clinical study
Based on the Diagnosis and Treatment Protocol for COVID-19 Pneumonia Trial 10th edition and according to the results of phase I and Phase II clinical studies one dose group and one placebo group were used in this experiment The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment The clinical study was led by the First Affiliated Hospital of the Chinese Peoples Liberation Army and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese Peoples Liberation Army the Second Affiliated Hospital of the Chinese Peoples Liberation Army the Special Medical Center of the Air Force and the Third Peoples Hospital of Shenzhen A ratio of 1 to 1 was randomly assigned to the experimental or placebo groupsSubjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication The administration schedule was on day 1 of the trial intravenous infusion of Meplazumab or placebo once in the morning of D0 The dosage was 02 mgkg If the 12 common clinical symptoms of SARS-CoV-2 infection are not relievedthe first administration of D7 an additional dose of 02 mgkg is given based on the body weight of the subjects
Based on the Diagnosis and Treatment Protocol for COVID-19 Pneumonia Trial 10th edition and according to the results of phase I and Phase II clinical studies one dose group and one placebo group were used in this experiment The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment The clinical study was led by the First Affiliated Hospital of the Chinese Peoples Liberation Army and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese Peoples Liberation Army the Second Affiliated Hospital of the Chinese Peoples Liberation Army the Special Medical Center of the Air Force and the Third Peoples Hospital of Shenzhen A ratio of 1 to 1 was randomly assigned to the experimental or placebo groupsSubjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication The administration schedule was on day 1 of the trial intravenous infusion of Meplazumab or placebo once in the morning of D0 The dosage was 02 mgkg If the 12 common clinical symptoms of SARS-CoV-2 infection are not relievedthe first administration of D7 an additional dose of 02 mgkg is given based on the body weight of the subjects
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled add-on Phase III clinical study
Based on the Diagnosis and Treatment Protocol for COVID-19 Pneumonia Trial 10th edition and according to the results of phase I and Phase II clinical studies one dose group and one placebo group were used in this experiment The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment The clinical study was led by the First Affiliated Hospital of the Chinese Peoples Liberation Army and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese Peoples Liberation Army the Second Affiliated Hospital of the Chinese Peoples Liberation Army the Special Medical Center of the Air Force and the Third Peoples Hospital of Shenzhen A ratio of 1 to 1 was randomly assigned to the experimental or placebo groupsSubjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication The administration schedule was on day 1 of the trial intravenous infusion of Meplazumab or placebo once in the morning of D0 The dosage was 02 mgkg If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved remission is defined as the comprehensive score of the 12 common clinical symptoms of SARS-CoV-2 infection is reduced by at least 1 grade after the first administration of D7 an additional dose of 02 mgkg is given based on the body weight of the subjectsDuring hospitalization each subject completed the relevant examination indicators of each visit according to the test requirements The subjects can be discharged if they meet one of the following conditions ① The discharge criteria of Diagnosis and Treatment Protocol for COVID-19 Infection Trial 10th edition the condition is significantly improved vital signs are stable body temperature is normal for more than 24 hours lung imaging lesion is significantly improved and the nucleic acid test of COVID-19 is negative for 1 time ② to the 14th day after the first administration Before discharge subjects should complete all discharge examinations and after discharge subjects do not need to do other examinations but 12 common clinical symptoms of SARS-CoV-2 infection should be recorded every day until the symptoms return to normal score 0 and continue for at least 2 days Long-term follow-up evaluation was conducted at D15-21 and D22-27 after administration by telephone to determine the safety of the test drugOn day 28 after the first dose D282 subjects returned to the study center again for all group exit examinations If the subject terminates the trial early for any reason laboratory testing and chest imaging evaluation are required to complete the efficacy and safety assessment During the trial subjects were given
Both the experimental group and the control group received basic treatment including symptomatic drugs for 12 common clinical symptoms of SARS-CoV-2 infection Because NSaids glucocorticoids and antiviral drugs have great influence on the evaluation of experimental drugs the following restrictions are made 1 Subjects are not allowed to self-administer NSaids during the study if their fever is 385 andor pain related symptoms are assessed as severe among the 12 common clinical symptoms of SARS-CoV-2 infection score 3 points loxoprofen sodium 60 mg time not more than 2 times during the test and the specific medication information was truthfully recorded 2 When the subjects symptoms are further aggravated and require loxoprofen sodium for more than 3 times or glucocorticoid drugs Antiviral therapy such as Paxlovid Nematvir tabletRitonavir tablet combination package azivudine tablets Monoravir capsules ambavir mabRomisivir injection human immunoglobulin for COVID-19 or convalescent plasma for convalescent patients and other antipyretic and analgesic agents other than loxoprofen sodium prescribed in the protocol The subjects were required to leave the group and complete the last follow-up before leaving the group
During the study the researcher can add examination items according to the actual situation and all abnormal and clinically significant changes occurred in the subjects during the observation period and before leaving the group shall be followed up until the subjects return to normal or are deemed to be clinically insignificant by the researcher
Study end is defined as the last visit of the last subject or the last data point used for statistical analysis whichever is the latest The last subject refers to the last enrolled case
Based on the Diagnosis and Treatment Protocol for COVID-19 Pneumonia Trial 10th edition and according to the results of phase I and Phase II clinical studies one dose group and one placebo group were used in this experiment The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment The clinical study was led by the First Affiliated Hospital of the Chinese Peoples Liberation Army and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese Peoples Liberation Army the Second Affiliated Hospital of the Chinese Peoples Liberation Army the Special Medical Center of the Air Force and the Third Peoples Hospital of Shenzhen A ratio of 1 to 1 was randomly assigned to the experimental or placebo groupsSubjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication The administration schedule was on day 1 of the trial intravenous infusion of Meplazumab or placebo once in the morning of D0 The dosage was 02 mgkg If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved remission is defined as the comprehensive score of the 12 common clinical symptoms of SARS-CoV-2 infection is reduced by at least 1 grade after the first administration of D7 an additional dose of 02 mgkg is given based on the body weight of the subjectsDuring hospitalization each subject completed the relevant examination indicators of each visit according to the test requirements The subjects can be discharged if they meet one of the following conditions ① The discharge criteria of Diagnosis and Treatment Protocol for COVID-19 Infection Trial 10th edition the condition is significantly improved vital signs are stable body temperature is normal for more than 24 hours lung imaging lesion is significantly improved and the nucleic acid test of COVID-19 is negative for 1 time ② to the 14th day after the first administration Before discharge subjects should complete all discharge examinations and after discharge subjects do not need to do other examinations but 12 common clinical symptoms of SARS-CoV-2 infection should be recorded every day until the symptoms return to normal score 0 and continue for at least 2 days Long-term follow-up evaluation was conducted at D15-21 and D22-27 after administration by telephone to determine the safety of the test drugOn day 28 after the first dose D282 subjects returned to the study center again for all group exit examinations If the subject terminates the trial early for any reason laboratory testing and chest imaging evaluation are required to complete the efficacy and safety assessment During the trial subjects were given
Both the experimental group and the control group received basic treatment including symptomatic drugs for 12 common clinical symptoms of SARS-CoV-2 infection Because NSaids glucocorticoids and antiviral drugs have great influence on the evaluation of experimental drugs the following restrictions are made 1 Subjects are not allowed to self-administer NSaids during the study if their fever is 385 andor pain related symptoms are assessed as severe among the 12 common clinical symptoms of SARS-CoV-2 infection score 3 points loxoprofen sodium 60 mg time not more than 2 times during the test and the specific medication information was truthfully recorded 2 When the subjects symptoms are further aggravated and require loxoprofen sodium for more than 3 times or glucocorticoid drugs Antiviral therapy such as Paxlovid Nematvir tabletRitonavir tablet combination package azivudine tablets Monoravir capsules ambavir mabRomisivir injection human immunoglobulin for COVID-19 or convalescent plasma for convalescent patients and other antipyretic and analgesic agents other than loxoprofen sodium prescribed in the protocol The subjects were required to leave the group and complete the last follow-up before leaving the group
During the study the researcher can add examination items according to the actual situation and all abnormal and clinically significant changes occurred in the subjects during the observation period and before leaving the group shall be followed up until the subjects return to normal or are deemed to be clinically insignificant by the researcher
Study end is defined as the last visit of the last subject or the last data point used for statistical analysis whichever is the latest The last subject refers to the last enrolled case
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None