COVID-19 trials registries data warehouse

http://en.irct.ir/trial/48401

hasan adeli

adeli@muq.ac.ir

2020-09-19

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

Adults (defined) as older than 18 years and younger than 60 years Laboratory confirmation of Covid19 infection with reverse transcription polymerase chain reaction (RT-PCR) from oropharyngeal or nasopharyngeal swab Covid19-related new organ dysfunction, including hypoxia due to the need for supplemental oxygen to maintain oxygen saturation greater than 94%, hypotension (systolic blood pressure less than 90 mm Hg) or the need for vasopressor, an inotropic drug ( Renal impairment (increase in creatinine by more than 50% from baseline, decrease in glomerular filtration rate by more than 25% from onset or urination less than 0.5 ml / kg for 6 hours, decrease in Glasgow scale by 2 or more, ie 13 or less Out of 15 points, thrombocytopenia less than 150,000 platelets per millimeter, gastrointestinal symptoms requiring hospitalization (eg severe nausea, vomiting, diarrhea or abdominal pain)

Sensitivity or sensitivity to Lopinavir or Ritonavir or recombinant IFN-β1b, including, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema or angioedema syndrome. Use of drugs that are contraindicated with lopinavir/ritonavir and should not be substituted or discontinued during the study period, such as inhibitors CYP3A Pregnancy-Eligible female participants of childbearing age are tested for pregnancy before enrolling in the study HIV infection is known to cause concern about the resistance to lepinavir / ritonavir if used in combination with other anti-HIV drugs. Hemoglobin under 8 Known heart failure EF under 50% According to the 31st National Guide, all vulnerable groups, such as the mentally disabled, emergency patients, or prisoners, are excluded from the study.

2

Ghoum University of Medical Sciences

18

60

Iran

Severe disease at enrollment

6: Severe disease at enrollment

60

The primary outcome (mortality within 30 days after hospitalization)

Phase 3

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