Effect of Prednisolone on treatment of COVID-19

Phase 2

Recruiting

Conditions: COVID-19 disease.
COVID-19
U07.2, U07

Registration Number: IRCT20081027001411N3

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

COVID-19 patient with Acute Respiratory Distress Syndrome (ARDS) and confirmed by positive PCR test for SARS-CoV-2
or confirmed by abnormal CT scan finding (bilateral, sub pleural, peripheral ground glass opacities),
With blood oxygen saturation <93%,
Not responding to stamdard COVID-19 treatment after 48-72h

Exclusion Criteria

A history of type I diabetes, asthma and lung diseases, malignancies, kidney and heart failure, uncontrolled high blood pressure, positive pro-calcitonin and active infection
Taking immunosuppressive drugs and corticosteroids
Pregnant or lactating women
Prescribing antibiotics due to a bacterial infection

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic features findings. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: CT scan.;Mortality rate. Timepoint: Before and after treatment with Prednisolone. Method of measurement: Observation.;O2 saturation. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Pulse Oximeter.;Need for an oxygen therapy. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Clinical.

Secondary Outcome Measures

Name	Time	Method
CBC laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.;ESR laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.;CRP laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.;Ferritin laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.;D-Dimer laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.;Troponin laboratory test. Timepoint: Before treatment with Prednisolone and at days 8 and 14 after treatment. Method of measurement: Para-clinical.