COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55708

Prakhar Gupta

itsme.prakhar@gmail.com

2021-05-31

Not recruiting

RCT

Randomized

Adaptive

Open label

single-center

Treatment

1.Male or non-pregnant female adult â?¥â??18â??years of age at the time of enrolment <br/ > <br/ >2.Confirmed diagnosis of SARS-CoV-2 infection, defined as either: <br/ > <br/ >a. <br/ >SARS-CoV-2 PCR positive within 72â??h before randomization <br/ > <br/ >or <br/ > <br/ >b. <br/ >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. <br/ > <br/ >3. Patients eligible for home isolation.

1. Moderate to Severe type of disease, with at least one of the following criteria: <br/ >o Frequency of breath > 24 per minute, which does not decrease after the body temperature drops to normal or subfebrile values, <br/ >o Blood oxygen saturation (SpO2) < 94% at rest, <br/ >o Chest involvement on HRCT <br/ >o Partial pressure of oxygen in arterial blood (PaO2) < 60 mm Hg, <br/ >o Oxygenation index (RaO2/FiO2) â?¤ 200 mm Hg, <br/ >o Partial pressure of CO2 in arterial blood (PaCO2) < 60 mm Hg, <br/ >o Septic shock. <br/ >2. Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening. <br/ >3. Severe cardiovascular diseases currently or 6 months prior to trial. <br/ >uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis. <br/ >4. Severe chronic renal impairment (GFR < 30 ml / min) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis. <br/ >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). <br/ >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 <br/ >8. Malignancies that require chemotherapy within 6 months prior to screening. <br/ >9. Known HIV infection. <br/ >10. Uncontrolled Diabetes Mellitus. <br/ >11. Participation in other clinical studies or taking other study drugs within 28 days prior to screening. <br/ >12. Pregnant or lactating women. <br/ >13. Patients not giving consent.

2

JK Hospital and LN Medical College

18

99

India

Mild disease at enrollment

1: Mild disease at enrollment

500

Number of patients requiring hospitalisation; supplemental oxygen and/or ICU care as compared to Standard of care protocol. <br/ > <br/ >Timepoint: Baseline; 7 days; 14 days and if applicable-ICU Status/ hospitalisation time

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]