COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=66852

Dr Nilesh Patel

nileshp@panexcell.com

2022-03-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Patient with RT-PCR positive for nCOVID-19 within last 72 hours with Ct value > 17. <br/ >2. Male and female patients with age above 18 years and below 65 years of age. <br/ >3. Patient with ARVI score atleast 2 or more. <br/ >4. Patient willing to provide informed consent to participate into the trial. <br/ >5. Patient able to complied requirement of study and protocol. <br/ >6. Patient with SpO2 > 94 %, Respiratory rate < 24/min and temperature < 104 °F <br/ >

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. Patient was on immunomodulatory drug. <br/ >5. Patient who has participated in other clinical study related to nCOVID 19. <br/ >6. 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/ >7. 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/ >8. Patient of Hypertension and/or Diabetes who was not on stable treatment in past 3 month. <br/ >9. Known history of Chronic Kidney disease. <br/ >10. Known history of Chronic Liver disease. <br/ >11. Reports of any history of malignancy. <br/ >12. Nursing mother or pregnant women. <br/ >

2

Supreme Drugs Pvt Ltd

18

65

India

Mild disease at enrollment

1: Mild disease at enrollment

184

At least decrease in Ordinal Scale by 1 pointTimepoint: Day 4; Day 6

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 2428, "treatment_name": "Chlorine inhalation", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]