A Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy in Patients with Severe to Critical COVID-19 Infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036162
- Lead Sponsor
- Dr Manoj Kuriakose
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <90% on room air.
d.With/without Oxygenation impairment: (Mild ARDS: 200 mmHg < PaO2/FiO2 <= 300 mmHg (with PEEP or CPAP >=5 cm H2O); Moderate ARDS: 100 mmHg < PaO2/FiO2 <=200 mmHg with PEEP >=5 cm H2O); Severe ARDS: PaO2/FiO2 <= 100 mmHg with PEEP >=5 cm H2O)
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.
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 <30 ml/min)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â??Patient clinical status (8-point ordinal scale) at Day 15. <br/ ><br>1.Death <br/ ><br>2.Hospitalized, on invasive mechanical ventilation or ECMO <br/ ><br>3.Hospitalized, on non-invasive ventilation or high flow oxygen devices <br/ ><br>4.Hospitalized, requiring supplemental oxygen <br/ ><br>5.Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) <br/ ><br>6.Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. <br/ ><br>7.Not hospitalized, limitation on activities and/or requiring home oxygen <br/ ><br>8.Not hospitalized, no limitations on activities <br/ ><br>Timepoint: at day 15
- Secondary Outcome Measures
Name Time Method