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IRCT20160118026097N4 IRCT 2020-09-13 Ghoum University of Medical Sciences The effect of dexamethasone in the treatment of high-risk covid19 patients Evaluation of Dexamethasone treatment in high-risk covid19 patients in Qom 2020-03-29 anticipated 60 Complete https://irct.ir/trial/48310 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The patient will be visited every one to three months based on treatment needs And other follow-ups will be done by phone, Randomization description: This study will be performed by a random sampling method, block allocation. In such a way that In this study, 60 patients with corona will be randomly divided into two groups. The selection of groups will be based on the fact that individuals will be assigned to groups based on block randomization. Block size 4 is considered. So we have six blocks of four, ABAB, ABBA, AABB, BAAB BBAA, BABA. The selection of each block will also be random and will be done using dice. For example, if the number 5 comes in the dice roll, the AABB block is considered and Therefore, the first two patients are assigned to treatment A, and the two patients are then assigned to treatment B.The dice will be thrown ten times to complete the allocation of patients to treatment groups. Treatment with dexamethasone and control will also be based on accident (coin toss). 3 COVID19. Intervention group: After obtaining informed consent and a full explanation of the treatment steps to the patient and accompanying regarding the treatment process, In addition to receiving the Ministry of Health's treatment protocol, dexamethasone is treated daily 0/1mg/kg for a week.. Yes - There is a plan to make this available What will be shared: All data can be shared after people have not been identified When: Start the access period 6 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Use of meta-analysis Where to obtain: DR Jamshid vafaeemanesh How to obtain: Correspondence with the responsible author Comments: does not have
public hasan adeli
beheshti blv
qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2526 jvafaeemanesh@yahoo.com Ghoum University of Medical Sciences scientific jamshid vafaeemanesh
beheshti blv
qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2526 jvafaeemanesh@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years Laboratory confirmation of Covid19 infection with reverse transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source The new organ dysfunction, which is related to Covid19, includes: Hypoxia requires supplemental oxygen to maintain oxygen saturation> 90%. hypotension (systolic blood pressure <90 mmHg) or need for vasopressor / inotropic drug.Renal impairment (especially creatinine) 50% of baseline, onset, received based on glomerular filtration film. Reduce the scale of Glasgow 2 or more, Thrombocytopenia (<150,000 platelets per millimeter). Symptoms of gastrointestinal upset requiring hospitalization (eg, severe nausea, vomiting, diarrhea, or abdominal pain 18 years 70 years Both Sensitivity or sensitivity to Lopinavir / Ritonavir or recombinant IFN-β1b, including toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema or angioedema syndrome. ALT above 5 times normal Use of drugs that are contraindicated with Lupinavir / RitonavirAnd do not replace or stop during the study period, such as CYP3A inhibitors. Pregnancy - Eligible female participants are tested at gestational age before enrolling in a pregnancy study. HIV infection is known to cause concern about the resistance to lepinavir / ritonavir if used in combination with other anti-HIV drugs. Uncontrolled diabetes (Prohibition of prednisolone). According to the 31st National Guide, all vulnerable groups, such as the mentally disabled, emergency patients, or inmates, are excluded from the study. U07.1 COVID-19, virus identified Treatment - Drugs Intervention group: After obtaining informed consent and a full explanation of the treatment steps to the patient and accompanying regarding the treatment process, In addition to receiving the Ministry of Health's treatment protocol, dexamethasone is treated daily 0/1mg/kg for a week. Initial outcome (mortality rate or Recovery within 30 days after hospitalization). Timepoint: the experiment of RT-PCR In the lower respiratory tracts When entering the study and One week after treatment Repeat every week too Negative sample twice. Method of measurement: Examining and filling out checklists and performing RT-PCR tests. Days without organ support (eg, supplemental O2, mechanical ventilation, dialysis and vasopressors): 28 days 2- RT-PCR examination At the time of admission to the study and one week after treatment and every week to negative sample Twice.3-Body failure assessment scores 4-staying time in ICU A period of one year after discharge. 5 The duration of hospital stay - the period of one year after discharge6-Mechanical ventilation duration - one year after discharge.7-Chest radiographic findings Time interval: first and 28 days later.8-Number of patients with side effects from treatment over a period of 28 days Such as diabetes, hypothyroidism, hyperlipidemia, hypertension, cataracts, glaucoma, cushingoid complications and gastrointestinal and skin complications.9- ICU mortality - a period of one year after discharge. 10-Hospital mortality - a period of one year after discharge. Timepoint: The patient will be visited every one to three months of treatment based on the need for treatment and other follow-ups will be done by phone. Method of measurement: In-person examination and telephone follow-up. Deputy of Research and Technology of Qom University of Medical Sciences Approved 2020-04-28 Ethics committee of Qom University of Medical Sciences shahid beheshti Blv qom Ghoum Iran (Islamic Republic of)