COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45761

Dr Gayatri Gnau

vgvaidya178@gmail.com

2020-10-22

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Patients admitted with RT-PCR confirmed COVID-19 illness <br/ >Age > 18 & < 65 years of either sex <br/ >Mild to Moderately Covid 19 disease (NEWS score â?¤ 8) <br/ >Signed informed consent must be obtained and documented according to AYUSH GCP, and <br/ >national/local regulations.

Pregnant women <br/ >Breastfeeding women <br/ >Requiring ICU admission at screening <br/ >Patients above 65 years of age and below 18 Years <br/ >Past History of MI, Epileptic episodes <br/ >Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which <br/ >is at critical stage at screening <br/ >Any other condition by which subject proves unfit from investigator perspective <br/ >Not giving consent.

2

RV New Vision Healthcare Pvt Ltd

18

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

No. of days required for negative PCR confirmatory test <br/ >Change in clinical symptom presentation <br/ >Clinical status expressed in percentage of subjects reporting each severity rating <br/ >Changes in X ray <br/ >Changes in inflammatory mediators like CRP; LDH and ferritinTimepoint: 10 days or negative PCR test for Covid 19 whichever is earlier

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

Phase 2

[{"arm_notes": "", "treatment_id": 1136, "treatment_name": "Rv forte", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]