COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44303

Divya C

pm@bioagiletherapeutics.com

2020-08-31

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Subject will be included in the study if all the below criteria are â??yesâ?? <br/ >1. Male and nonpregnant female patients 18 years of age or older eligible if they had a diagnostic specimen that was positive on RT-PCR. <br/ >2. For Mild â?? Moderate cases: Positive nasal swab test for Covid 19 at screening. <br/ >3. For Severe cases - Has an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg. <br/ >4. Ability to understand and the willingness to sign a written informed consent document. <br/ >

1.Female subjects who are pregnant or breastfeeding. <br/ >2. Patients who are allergic to this medicine <br/ >3. Patients allergic to content of study product <br/ >4. Patients with diabetes. <br/ >5. Patients accompanied by serious physical diseases of heart, lung, brain, etc. <br/ >6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. <br/ >7. Patients who are not able to take drugs orally. <br/ >

2

NatureCeuticals Sdn Bhd

18

100

India

No restriction on type of patients

0: No restriction on type of patients

10

time to clinical improvement; defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital; whichever comes first. <br/ > <br/ >3. Change in standard diagnosis: Serum c-reactive protein (CRP); IgG; Hb; Total leucocyte count and differential leucocyte count. <br/ >4. Change in urinary F2-Isoprostane from baseline to remission <br/ >Timepoint: Screening and Day14

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

Not reported

[{"arm_notes": "", "treatment_id": 917, "treatment_name": "Nuvastatic", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]