COVID-19 patients with kidney injury
Conditions
Interventions
Treatment group (Renal dialysis group):F61 injection+standard treatment
Contoll group (Renal dialysis group):Standard treatment
Treatment group (Non renal dialysis group: <60 VS =60 ml/min/1.73 m2):F61 injection+standard treatment
Control group (Non renal dialysis group: <60/ =60 ml/min/1.73 m2):Standard treatment (Azvudine, oxygen therapy and anticoagulant therapy, etc/Paxlovid, oxygen therapy and anticoagulant therapy, etc)
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: To be included in the study, participants must meet all of the following criteria: (1) The subject is between 18 and 80 years old, male or female, at the time of signing the ICF; (2) The test result of SARS-CoV-2 nucleic acid is positive; (3) Maintenance hemodialysis patients or hospitalized patients with kidney damage (consistent with abnormal urinary sediment, abnormal renal imaging, abnormal renal pathology, or eGFR < 60 ml/min/1.73 m2); (4) Within 6 months from the signing of informed consent to the administration of the study drug, the subject (including the partner) has no pregnancy plan and voluntarily takes effective contraceptive measures; (5) The subject has clear consciousness, is able to communicate well with the investigator, understands and complies with the requirements of the study, understands and signs the ICF.
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if they meet any of the following criteria: Illness: (1) Patients are classified as critical patients according to the ninth trial edition of the Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol issued by the National Health Commission of the People's Republic of China (NHC); (2) Suspected or confirmed severe, active bacterial, fungal, viral, or other infection (other than COVID-19) that the investigator believes may pose a risk at the time of intervention; (3) ALT or AST>3 times ULN during the screening period; (4) Those who have had severe allergic reactions to drugs in the past; Prior/concomitant therapy (5) Patients who received SARS-CoV-2-specific immunoglobulin (including monoclonal antibody) treatment 3 months before screening; (6) Patients with a history of receiving convalescent COVID-19 plasma therapy within 3 months prior to administration; Previous/current clinical research experience (7) Participating in other drug clinical trials within 1 month before screening; (8) Other factors considered inappropriate by the researchers to be included in this study. Other exclusion criteria (9) Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint: proportion of subjects with clinical classification progression and death within 8 days of enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 15 day all-cause mortality rate;The proportion of light and ordinary types progressing to heavy/hazardous heavy;Percentage of subjects with negative SARS-CoV-2 on days 3, 5, and 8;Changes in symptom scores (total score) from baseline on days 3, 5, and 8 (patient self-assessment);Changes from baseline in the World Health Organization (WHO) 10 point disease progression scale on days 3, 5, and 8;Changes in lung CT from baseline on days 3 and 8 (progression/improvement in lobes, segments, and layers);Changes in SARS-CoV-2 viral load from baseline in swab samples (preferred nasopharyngeal swab) on days 3, 5, and 8;Changes in white blood cells, D-dimer, lymphocytes, interleukin-6 (IL-6), C-reactive protein (CRP), heparin binding protein, procalcitonin, and ferritin from baseline on days 3, 5, and 8;The incidence and severity of adverse events (TEAEs) and severe adverse events (SAEs) during treatment; | — |
Countries
China
Contacts
Public ContactXiangmei Chen
Chinese PLA General Hospital
Outcome results
None listed