CTRI/2020/08/027475
Recruiting
Phase 3
Randomized Controlled Trial Of Immunomodulator Mycobacterium w In Mild And Moderate Cases of Covid-19 Pneumonia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cadila Pharmaceuticals Limited
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age More Than 18 in both genders.
- •Mild to moderate covid 19 pneumonia
- •Consented for study
Exclusion Criteria
- •Received cardiopulmonary resuscitation,
- •On long standing immunosuppressive therapy,
- •Unwilling to provide consent.
- •Complete blood count serum Dâ??dimer, Câ??reactive protein (CRP), procalcitonin and IL6 levels will be done for all patients. As per our institutional protocol, all patients will receive standard medical care comprising oral paracetamol (for fever), oral proton pump inhibitor for stress ulcer prophylaxis (pantoprazole 40 mg/day), and low molecular weight heparin for deep venous thrombosis prophylaxis (enoxaparin 1 mg/kg, once daily). Therapeutic anticoagulation (enoxaparin 1 mg/kg, twice daily) will be given in patients who will have D dimer levels \>500 ng/ mL. Dexamethasone 6 mg iv daily will be used for 7 days. Antibiotics (azithromycin or doxycycline ) will be used in patients with a total leukocyte count of \>11,000 cell/μL, procalcitonin \>0\.5 ng/mL, or if they have hypotension (mean arterial blood pressure \<65 mmHg). We will not use hydroxychloroquine in any of these patients. We will use intradermal Mw (0\.3 mL/day \[0\.1 mL contains 0\.5 Ã? 109 heat\- killed Mw] for 3 consecutive days, in addition to standard medical care.
Outcomes
Primary Outcomes
Not specified
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