COVID-19 trials registries data warehouse

http://en.irct.ir/trial/48310

ehsan sharifipour

ehsansharifipoor@yahoo.com

2020-09-13

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

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.

2

Ghoum University of Medical Sciences

18

70

Iran

Severe disease at enrollment

6: Severe disease at enrollment

60

Initial outcome (mortality rate or Recovery within 30 days after hospitalization)

Phase 3

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