A Phase III multicentric prospective comparative clinical trial to evaluate efficacy and safety of LifeViroTreat inhalation in mild nCOVID-19 infected patient
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: U071- COVID 19 virus identified
- Registration Number
- CTRI/2022/03/041214
- Lead Sponsor
- Supreme Drugs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patient with RT-PCR positive for nCOVID-19 within last 72 hours with Ct value > 17.
2.Male and female patients with age above 18 years and below 65 years of age.
3.Patient with ARVI score atleast 2 or more.
4.Patient willing to provide informed consent to participate into the trial.
5.Patient able to complied requirement of study and protocol.
6.Patient with 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.
2.Patient having past history of respiratory disorder like COPD, Asthma etc.
3.Patient is on medication before tested nCOVID 19 positive for respiratory disease or disorder (other than viral infection).
4.Patient was on immunomodulatory drug.
5.Patient who has participated in other clinical study related to nCOVID 19.
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..
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.
8.Patient of Hypertension and/or Diabetes who was not on stable treatment in past 3 month.
9.Known history of Chronic Kidney disease.
10.Known history of Chronic Liver disease.
11.Reports of any history of malignancy.
12.Nursing mother or pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At least decrease in Ordinal Scale by 1 pointTimepoint: Day 4, Day 6
- Secondary Outcome Measures
Name Time Method CGI-I and CGI-S assessment <br/ ><br>Change in ordinal scale from baseline <br/ ><br>Proportion of patient require Oxygen <br/ ><br>Proportion of patient require hospitalization <br/ ><br>Change in ARVI score <br/ ><br>Proportion of patient with resolution of ARVI score <br/ ><br>Change in CRP, D-Dimer <br/ ><br>All -cause mortality <br/ ><br>Change from baseline in log Viral load <br/ ><br>Time to alleviation of flu like nonspecific symptoms <br/ ><br>Time to alleviation of Nasal/Throat/Chest specific symptoms <br/ ><br>Time to alleviate loss of appetite symptom <br/ ><br>Proportion of patient withdrawn from treatment <br/ ><br>Proportion of patient drop out from treatment <br/ ><br>Comparison of Adverse Event <br/ ><br>Timepoint: Day 4, Day 6 and Day 14