COMPASSIONATE COVID-19 TREATMENT PROJECT INTENDED TO EVALUATE SAFETY AND EFFICACY OF THE NIMRCAF, COVIDOL AND BUPIJI OIL – THE HERBAL PREPARATIONS FOR THE TREATMENT OF COVID-19 PATIENTS
Phase 2
- Conditions
- Coronavirus Disease 2019
- Registration Number
- PACTR202204600690227
- Lead Sponsor
- Kilimanjaro Clinical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 416
Inclusion Criteria
• Confirmed COVID-19 patients aged eighteen years and above
• Hospitalized and with moderate or severe form of disease, during the study period at any of the study sites
• Consented participant
Exclusion Criteria
• Unconsented participant
• Patient with any clinically significant Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale
• Patient aged less than eighteen years
• Patient with peptic ulcers
• History of using any of the investigational herbal preparations
• Pregnant women
• COVID-19 patients with mild signs and symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the frequency, severity, and duration of adverse events. The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events will be evaluated through study completion.
- Secondary Outcome Measures
Name Time Method IMRCAF, Covidol or Bupiji oil preparation will be declared to have efficacy on the management of the COVID-19 during the observational period through:<br>• Reduction of number of corona virus as measured CT value<br>• Duration of hospitalization<br>• Duration of clearance of the presenting signs and symptoms<br>• Mortality