Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Combination of homeopathic medication: Combination of homeopathic medication (Arsenicum Album +Bryonia Alba + Phosphorus)
Control Intervention1: Standard of Care (SOC): The Standard of
Sponsors
Dr Manoj Kuriakose
All India Institute of Medical Sciences Bhopal
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 2. Male and female subjects greater than 18 years of age. 3. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR, Rapid Antigen Test, CBNAAT or CT suggestive of Pneumonia (CO-RADS 5 grade). 4. Adult with radiological signs of pneumonia (chest x-ray, CT scan, etc.) plus one of the following. a. respiratory rate >30 breaths/min, b. severe respiratory distress, c. SpO2 d. With/without Oxygenation impairment: (Mild ARDS: 200 mmHg 5. Patient with or without pre-existing significant co-morbidities (e.g. lung diseases, diabetes, hypertension) at the discretion of the investigator. 6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods. 7. Willingness and ability to comply with trial and follow-up procedures. 8. Ability to understand the nature of the trial and give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient with mild-moderate COVID-19 infection 2. Patients who are allergic to arsenic album products 3. Severely immunocompromised patients for example patients with a history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency. 4. ALT/AST > 5 times the upper limit of normal. 5. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR 6. Subjects who is receiving Covid-19 directed alternative medication (e.g. Any ayurvedic, Unani or homeopathic) 7. Participation of patient in other investigational clinical studies 8. Pregnant or breastfeeding. 9. Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study. 10. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ???Patient clinical status (8-point ordinal scale) at Day 15. 1.Death 2.Hospitalized, on invasive mechanical ventilation or ECMO 3.Hospitalized, on non-invasive ventilation or high flow oxygen devices 4.Hospitalized, requiring supplemental oxygen 5.Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6.Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7.Not hospitalized, limitation on activities and/or requiring home oxygen 8.Not hospitalized, no limitations on activities Timepoint: at day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ??? To assess the Clinical Severity: 1. Ordinal scale: - Time to an improvement of one category from admission using an ordinal scale. - Subject clinical status using ordinal scale at Days 3, 5, 8, 11, and 29. (Ordinal outcome will be assessed daily while hospitalized and on Days 15, 22 and 29) 2. National Early Warning Score (NEWS): - The time to discharge or to a NEWS of ââ?°Â¤ 2 and maintained for 24 hours, whichever occurs first. (NEWS will be assessed daily while hospitalized and on Days 15, 22 and 29) 3. Length of stay - Length of stay (ICU or ward)in days. 4. Mortality in ICU patients 5. Need of admitting to ICU for patients admitted in wards. ââ??? To evaluate the safety - Incidence of serious adverse events (SAEs) - Incidence of Grade 3 and 4 adverse events (AEs). - Discontinuation or temporary suspension of study drug (for any reason). Timepoint: 1. Subject clinical status using ordinal scale at Days 3, 5, 8, 11, and 29. (Ordinal outcome will be assessed daily while hospitalized and on Days 15, 22 and 29) 2.National Early Warning Score (NEWS): - The time to discharge or to a NEWS of ââ?°Â¤ 2 and maintained for 24 hours, whichever occurs first. (NEWS will be assessed daily while hospitalized and on Days 15, 22 and 29 ;ââ???Percentage change in the biomarkers such as IL-4, IL-6, CRP, ferritin, d-dimer and troponin CTimepoint: on day 1,3,5,8 and 11 | — |
Countries
India
Contacts
Public ContactDr Ashish Kumar Dixit
All India Institute of Medical Sciences Bhopal
Outcome results
None listed