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The effect of dexamethasone in the treatment of high-risk covid19 patients

Phase 3
Conditions
COVID19.
COVID-19, virus identified
U07.1
Registration Number
IRCT20160118026097N4
Lead Sponsor
Ghoum University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

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

Exclusion Criteria

Sensitivity or sensitivity to Lopinavir / Ritonavir or recombinant IFN-ß1b, 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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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