CTRI/2021/05/033873尚未招募未知
AN OPEN-LABEL, ADAPTIVE, RANDOMISED COMPARATIVE TRIAL OF PRE-EMPTIVE GLUCOCORTICOIDS VERSUS STANDARD OF CARE PROTOCOL FOR HOME ISOLATED MILD CATEGORY COVID-19 PATIENTS: PRESTECOV TRIALâ??. - PRESTECOV
JK Hospital and LN Medical College0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or non-pregnant female adult >=â??18â??years of age at the time of enrolment
- •2.Confirmed diagnosis of SARS-CoV-2 infection, defined as either:
- •SARS-CoV-2 PCR positive within 72â??h before randomization
- •In patients without PCR-confirmed diagnosis at inclusion, all efforts will be made to confirm definite SARS-CoV-2 infection (e.g., PCR on bronchial aspirate, PCR on BAL fluid or serologic testing). Participants whoâ??despite all effortsâ??do not have a confirmed diagnosis of COVID-19 will be excluded from the analysis.
- •3. Patients eligible for home isolation.
排除标准
- •1.Moderate to Severe type of disease, with at least one of the following criteria:
- •oFrequency of breath > 24 per minute, which does not decrease after the body temperature drops to normal or subfebrile values;
- •oBlood oxygen saturation (SpO2) < 94% at rest;
- •oChest involvement on HRCT
- •oPartial pressure of oxygen in arterial blood (PaO2) < 60 mm Hg;
- •oOxygenation index (RaO2/FiO2) <= 200 mm Hg;
- •oPartial pressure of CO2 in arterial blood (PaCO2) < 60 mm Hg;
- •oSeptic shock.
- •2.Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening.
- •3.Severe cardiovascular diseases currently or 6 months prior to trial.
- •uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis.
- •4.Severe chronic renal impairment (GFR < 30 ml / min) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
- •5.A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 5 times Ã? upper limit of normal (ULN).
- •7.Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic, endocrinological or gastrointestinal disorder which according to the Investigator, could prevent the patient from participating in the study
- •8.Malignancies that require chemotherapy within 6 months prior to screening.
- •9.Known HIV infection.
- •10.Uncontrolled Diabetes Mellitus.
- •11.Participation in other clinical studies or taking other study drugs within 28 days prior to screening.
- •12.Pregnant or lactating women.
- •13. Patients not giving consent.
研究者
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