COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05675943

Jing Pan

panj@borenhospital.com

2023-01-09

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: subjects in this study must meet all of the following criteria: male or female patients with hematological malignancies who are in stable condition or with bone marrow failure disorders and aged from 1 to 75 years old on the day of enrollment; on the day of enrollment, the subject was judged to be positive for covid-19 nucleic acid/antigen for more than 10 days without turning negative or had turned negative but recovered positive again after 10 days; on the day of enrollment, patients who have received car t-cell therapy, corticosteroids for a long time or other immuno-suppressive drugs, with the proportion of peripheral blood b cells is less than 2%; subjects (men and women with childbearing potential) and their sexual partners voluntarily take effective contraceptive measures from 4 weeks before screening to 3 months after the last dose of the test drug, and have no plan to donate sperm or eggs; subjects voluntarily participate in the trial and sign the informed consent form before the study begins.

those who meet any of the following conditions will be excluded: those who are known to be allergic to the test drug and any component in the preparation, or other similar drugs; complications requiring surgery within 7 days, or complication considered life-threatening within 28 days; received treatment with sars-cov-2 neutralizing antibody drugs before screening; convalescent plasma from recovered patients before screening; patients who took anti-sars-cov-2 drugs within 48 hours before enrollment, including but not limited to paxlovid (nirmatrelvir/ritonavir), azvudine, molnupiravir, etc. on the day of enrollment, meet the diagnostic criteria for severe/critical new coronavirus pneumonia; suspected to have been combined with active bacteria, fungi, viruses or other infections other than the new coronavirus; those who plan to become pregnant, are pregnant, or are breastfeeding; participated in clinical trials of sars-cov-2 neutralizing antibody drugs within 180 days before screening or participated in clinical trials of other drugs or medical devices within 4 weeks before screening; suffering from severe neurological diseases (epilepsy, convulsions or convulsions) or mental illness, with a family history of mental illness; suffering from other serious diseases that are not controlled, such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, endocrine system diseases; or other diseases that the researchers judge are not suitable for participating in the study (such as currently uncontrolled autoimmune diseases, etc. ); other conditions that the researcher believes are not suitable for participating in this study due to various reasons.

2

Beijing Boren Hospital

1

75

China

High risk patients

N/A

160

Time when the subject has nucleic acid and the antigen test continues to turn negative

None

Not reported

[{"arm_notes": "nan", "treatment_id": 2678, "treatment_name": "Anti-covid-19 antibody", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]