A Randomized Controlled Trial Of An Immunomodulator Mycobacterium w In Mild To Moderate Covid-19 Pneumonia

"Randomized Controlled Trial Of Immunomodulator Mycobacterium w In Mild And Moderate Cases of Covid-19 Pneumonia"

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027475

Enrollment

Registered

2020-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B342- Coronavirus infection, unspecified

Interventions

Intervention1: inj sepsivac 0.3 ml intradermal once a day for 3 days: inj sepsivac 0.3 ml intradermal once a day for 3 days Control Intervention1: normal saline: 0.3 ml intradermal once a day for 3 da

Eligibility

Inclusion criteria

Inclusion criteria: Age More Than 18 in both genders. Mild to moderate covid 19 pneumonia Consented for study

Exclusion criteria

Exclusion criteria: Pregnancy, 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/Î¼L, procalcitonin >0.5 ng/mL, or if they have hypotension (mean arterial blood pressure

Design outcomes

Primary

Measure	Time frame
28 days mortalityTimepoint: 28 days mortality	—

Secondary

Measure	Time frame
Ventilator Free Days, Icu Days, Hospital Stay.Timepoint: 28 Days	—

Countries

India

Contacts

Public ContactDr Shweta Ram Chandankhede

Care Hospital, Banjara Hills

shwets0106@gmail.com9963431945

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026