COVID19. COVID-19, virus identified
Conditions
Interventions
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 Ministr
Sponsors
Ghoum University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contacthasan adeli
Ghoum University of Medical Sciences
Outcome results
None listed