COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58404

Dr Nilesh Patel

nileshp@panexcell.com

2021-07-29

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. RT-PCR positive for nCOVID-19 within last 72 hours <br/ >2. Male and female patients with age above 18 years and below 65 years of age. <br/ >3. Patient willing to provide informed consent to participate into the trial. <br/ >4. Patient able to comply requirement of study and protocol. <br/ >5. Patient having SpO2 > 94 %, Respiratory rate < 24/min and temperature < 104 °F

1 Known hypersensitivity or idiosyncratic reaction to Chlorine or any of related substance or ingredient of the formulation. <br/ >2 Patient having past history of respiratory disorder like COPD, Asthma etc. <br/ >3 Patient is on medication before tested nCOVID 19 positive for respiratory disease or disorder (other than viral infection). <br/ >4 Patients who are diagnosed and/or on treatment for venous thromboembolism, ischemic heart disease, myocardial infarction, congestive cardiac failure, unexplained vaginal bleeding with suspicion of serious underlying condition, history of breast or cervical cancer, malignant tumor <br/ >5 Patient of Hypertension and/or Diabetes who was not on stable treatment in past 3 month. <br/ >6 Patient was on immunomodulatory drug <br/ >7 Have participated in other clinical study related to nCOVID 19 <br/ >8 Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial. <br/ >9 Known history of Chronic Kidney disease <br/ >10 Known history of Chronic Liver disease <br/ >11 Nursing mother or pregnant women

3

Supreme Industries

18

65

India

Mild disease at enrollment

1: Mild disease at enrollment

46

-Percentage of patients turning RT-PCR negative (success of treatment) at end of treatment (Day 4 or Day 6). <br/ >-Percentage of patients require hospitalizationTimepoint: Day 4 <br/ >Day 6

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

Phase 2

[{"arm_notes": "15 min;every 4h;3 to 5 days", "treatment_id": 1888, "treatment_name": "Life vitro treat", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "15 min;every 6h;3 to 5 days", "treatment_id": 1888, "treatment_name": "Life vitro treat", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]