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IRCT20210709051824N1 IRCT 2021-12-08 Men's Health and Reproductive Health Research Center(MHRHRC) Assessment of utility of Remdesivir in Patients with Acute Kidney Injury or Cronic Kidney Disease in admitted COVID-19 patients Assessment of utility of Remdesivir in Patients with Acute Kidney Injury or Cronic Kidney Disease in admitted COVID-19 patients 2021-12-22 anticipated 100 Complete https://irct.ir/trial/57516 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocking method (with unequal quadratic sizes) is used for random allocation, Blinding description: Participants in this study were kept blind (unilaterally blind) after obtaining informed consent to receive the drug or placebo. Medical staff and researchers are aware of this. 3 Condition 1: COVID-19. Condition 2: Acute Kidney Injury. Condition 3: Chronic Kidney Disease. Intervention 1: Intervention group: This group receives 200 mg Remdesivir on the first day as an intravenous infusion and then 100 mg daily up to 5 doses. Intervention 2: Control group: In this group, patients receive placebo with the same dose and number of times as the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet reached a conclusion with the other partners involved in the project for publication.
public Mahboobeh Freidoon
Tajrish
Tehran Iran (Islamic Republic of) 1989934148 25719 m.fereidoon@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahboobeh Freidoon
Tajrish
Tehran Iran (Islamic Republic of) 1989934148 25719 m.fereidoon@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with acute or chronic renal failure, with a definitive diagnosis of Covid 19, over the age of 18 years, and lung involvement above 20% or hypoxia (oxygen saturation less than or equal to 93%) Definitive diagnosis of Covid 19 Over the age of 18 years Pulmonary involvement caused by Covid 19 18 years no limit Both Previous history of COVID-19 infection and heart disease and receiving Remdesivir History of lung disease History of liver disease (such as hepatitis, cirrhosis) History of underlying diseases other than renal impairment that contribute to poor prognosis and increased mortality following coronary heart disease (eg, heart failure, active cancer, advanced diabetes with severe macrovascular and microvascular complications, previous stroke) Immunosuppressive use except in the field of kidney transplantation Prohibition of Ramdesivir (except low GFR) B34.2 N17 N18 Coronavirus infection, unspecified Acute kidney failure Chronic kidney disease (CKD) Treatment - Drugs Treatment - Drugs Intervention group: This group receives 200 mg Remdesivir on the first day as an intravenous infusion and then 100 mg daily up to 5 doses. Control group: In this group, patients receive placebo with the same dose and number of times as the control group. Red blood cell count. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. Platelet count. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. White blood cell count. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. Medium platelet volume. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. Erythrocyte Sedimentation Rate. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. CRP. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. AST. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. ALT. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. International Normalized Ratio(INR). Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. Bilirubin. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. Alkaline phosphatase. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. Cratinin. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. O2 Saturation. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Laboratory Kit. Lymphocyte count. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. Neutrophil count. Timepoint: The beginning of the visit, While receiving Remdesivir, after received Remdesivir. Method of measurement: Cell counter. Duration of hospitalization. Timepoint: End of hospitalization. Method of measurement: Hospitalization file. Result of hospitalization(Death or discharge). Timepoint: End of hospitalization. Method of measurement: Hospitalization file. Men's Health and Reproductive Health Research Center(MHRHRC) Approved 2021-09-19 Research Ethics Committees of Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medi Velenjak Tehran Tehran Iran (Islamic Republic of)