CelWel in Long Covid
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/12/048144
- Lead Sponsor
- Carmel Research Consultancy Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1.Patients with long covid symptoms
2.Male and female subjects ranging in age from 18
to 99 years.
3.Willingness to follow the protocol requirements
as evidenced by written, Informed Consent.
4.Mentally, physically and legally eligible to
give informed consent.
5.Willingness to complete study questionnaires.
1.Patients with pre-existing other severe systemic
disease necessitating long-term medication.
2.History of cancer, including solid tumours,
hematologic malignancies and carcinoma in situ
3.Any vascular or systemic disorder which could
affect any of the efficacy assessments
4.Subjects received other medication (anti-viral)
within the 36 hours before entry into the study
5.Evidence of significant uncontrolled co-morbid
disease which would jeopardize patient
participation
6.Patients hospitalized or requiring oxygen
support
7.Patients unable to take oral medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to End of the Study in responses to the symptom score and immunological profile among participants consenting to take CelWel <br/ ><br> <br/ ><br>For symptoms score we are using the standard long covid symptoms score prescribed by various health authorities including the ministry of Health in India. <br/ ><br> <br/ ><br>For immunological profile we are performing specific multiplex cytokine tests to look for specific patterns of expression of cytokines, monocytes and T LymphocytesTimepoint: At day 0, day 8 and day 14
- Secondary Outcome Measures
Name Time Method 1.Reduction of Biomarker from Baseline to End of the study.The Biomarker is Incelkine Laboratories based multplex cytokine screening. <br/ ><br> <br/ ><br>2.Incidence of adverse events (AEs) <br/ ><br> <br/ ><br>Timepoint: 1.For Biomarkers - At day 0 <br/ ><br> and day 14 <br/ ><br>2.For Adverse Events-Day 0 to Day 14 <br/ ><br> <br/ ><br>