]>
IRCT20200825048514N1 IRCT 2020-10-10 Yazd University of Medical Sciences Effect of β-interferon and methylprednisolone in COVID-19 The assessment of therapeutic effect of β-interferon and Methylprednisolone in patients with COVID- 19: A quasi-experimental, double-blind, placebo-controlled study 2020-05-04 anticipated 60 Complete https://irct.ir/trial/50543 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Blinding was performed without informing the patients about the type of treatment and with the consent of each patient's family. The selected participant in an intervention group is informed about the implementation and duration of the intervention, but does not know the type of intervention and the main purpose of the study. An independent statistical researcher from the study team assigned eligible patients in a 1: 1 ratio to the interferon beta and methylprednisolone combination group or the interferon beta group. An independent pharmacist from the experimental team (from the pharmacy of Shahid Sadoughi Hospital) placed the labels with the study ID on separate numbered packages for the combined treatment of interferon beta and methylprednisolone and interferon beta based on a list (M & C codes). Not all clinical and laboratory staff, and participants were aware of the type of treatment assigned to each individual, and only the pulmonologist responsible for each patient was aware of the type of treatment. 3 Covid- 19. Intervention 1: Intervention group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and one dose of 400 mg hydroxychloroquine. In the intervention group, 500 mg of methylprednisolone was administered weekly and 0.44 mg of β-interferon daily subcutaneously. Intervention 2: Control group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and a dose of 400 mg hydroxychloroquine. In the control group, 0.44 mg of β-interferon was administered subcutaneously daily. 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 There is no further information.
public Fatemeh sadat Aghaei meybodi
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4000 dr.meybodi@gmail.com Yazd University of Medical Sciences scientific Fatemeh sadat Aghaei meybodi
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4000 dr.meybodi@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age 18- 80 years Covid-19 infection based on high-resolution computed tomography findings Progressive and severe hypoxia based on blood oxygen saturation level less than 88% with a reservoir bag mask and flow of 15 liters Exacerbation of lymphopenia during hospitalization 18 years 80 years Both Cardiovascular patients Grade 3 and more liver cirrhosis Autoimmune diseases Severe depression and psychosis Organ transplantation Kidney failure Pregnancy U07.1 Covid- 19 Treatment - Drugs Treatment - Drugs Intervention group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and one dose of 400 mg hydroxychloroquine. In the intervention group, 500 mg of methylprednisolone was administered weekly and 0.44 mg of β-interferon daily subcutaneously. Control group: On the first day of hospitalization according to the national treatment protocol, Keltra received 400 mg daily (morning and night), naproxen 250 mg (morning and night) and a dose of 400 mg hydroxychloroquine. In the control group, 0.44 mg of β-interferon was administered subcutaneously daily. Body temperature. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Vital Sign Monitoring Device. Blood pressure. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Blood pressure cuff monitoring vital signs. Respiration rate. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Vital Sign Monitoring Device. O2 saturation. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Pulse oximeter. White blood cells. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurements are performed using an automatic blood cell counting device. Neutrophil. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurements are performed using an automatic blood cell counting device. Lymphocytes. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurements are performed using an automatic blood cell counting device. Platelet. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurements are performed using an automatic blood cell counting device. Erythrocyte Sedimentation Rate. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurement is done by centrifugation. C-Reactive Protein. Timepoint: At the beginning of the study (before the intervention) and during the days of hospitalization on a daily basis. Method of measurement: Measurements are performed by ELISA method. Yazd University of Medical Sciences Approved 2020-04-20 Ethics committee of Shahid Sadoughi University of medical sciences Bahonar Sq., Shahid Sadoughi Ave., Shahid Sadoughi University of Medical Sciences, Yazd Yazd Yazd Iran (Islamic Republic of)