Clinical trial of CIM-Meg19 to combat the severity of disorders in COVID-19 and post COVID-19 patients
- Conditions
- Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033472
- Lead Sponsor
- Ms Meghdoot Gramodyog Sewa Sansthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
a)Age- 35-90 years
b)Gender- Male or non-pregnant, non-lactating female patient aged >=35and<=90 years (both inclusive)
c)Mild to moderate cases of COVID-19
d)Capable of taking oral drugs
e)SpO2 > 93% in room air
f)PaO2 /FiO2 : 200-300
g)RR < 24 /min
h)No evidence of hypoxemia or breathlessness
i)Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.
a)Patients who are unwilling to participate in the study.
b)Patients with known sensitivity to any of the ingredients of the trial drug.
c)Presence of acute hypoxic respiratory failure.
d)Patients who require ICU stay.
e)Patients requiring mechanical ventilation.
f)Category 5 or 6 based on modified 7- category ordinal scale of clinical status.
g)Any pre-existing GI symptoms like nausea or vomiting.
h)Patients suffering from bleeding hemorrhoids.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In subjective QOL, using WHO QOLTimepoint: Day 0, 7, 14,21
- Secondary Outcome Measures
Name Time Method To assess the safety of the drug by monitoring for adverse events and laboratory parameters.Timepoint: OUTCOMESTIMELINE <br/ ><br>RT- PCR of nasal/oropharyngeal swabsDay 0, 7, 14,21 <br/ ><br>LDH, TLC, CRP, D-DIMER, IL-6Day 0, 7, 14, 21 <br/ ><br>Variations in clinical symptomsDay 0, 7, 14, 21 <br/ ><br>Haemogram, ESR, LFT, RFT, Lipid Profile, Blood Sugar, Urine â??R/MDay 0, 21 <br/ ><br>