Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: IMMURISE: Herbal ingredient extracted from:
â?¢ Turmeric (Curcuma longa)
â?¢ Lindi pepper (Piper longum)
â?¢ Ashwa gandha (Withania somnifera)
â?¢ Shatavari (Asparagus racemosus)
Dose:
Sponsors
Gujarat University
Dr Akshay Sevak
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able and willing to comply with the protocol, including availability for all scheduled study visits. 2. Male and Female patients aged from 18 years to 60 years old (both inclusive). 3. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures 4. Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours before randomization 5. Currently hospitalized or home quarantined and requiring medical care for COVID-19 6. Peripheral capillary oxygen saturation (SpO2) > 90% on room air at screening (without CIPAP/BIPAP support) 7. Radiographic evidence of pulmonary infiltrates 8. Altered Haematological and/or Biochemical parameter like CBC, ESR, CRP, Troponin, Liver function test, Renal function test at base line.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to active ingredients or to any of the excipients of drug 2. Patients with Severe respiratory/cardiac/renal/hepatic dysfunction which may require ventilator (CIPAP/BIPAP) or other interventional support.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 15. The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded.Timepoint: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ All cause mortalityTimepoint: day 21;â?¢ Appearance of IgG and/or IgM in serumTimepoint: on day 21;â?¢ Changes in Haematological and Biochemical parameter like CBC, ESR, CRP, Troponin, Liver function test, Renal function testTimepoint: First dose date up to 15 days;â?¢ Duration of hospitalizationTimepoint: within 21 days;â?¢ Duration of oxygen therapyTimepoint: within 21 days;â?¢ Proportion of participants in each group with need for mechanical ventilationTimepoint: within 21 days;â?¢ Proportion of participants in each group with normalization of feverTimepoint: day 7 and day 15;â?¢ Proportion of participants in each group with oxygen saturation 94% on room air for 24hTimepoint: day 7 and day 15;â?¢ Significant changes in the Chest X-Ray/CTTimepoint: before and after treatment;â?¢ Time to a normal body temperatureTimepoint: From the time of randomization until the time of normal body temperature, assessed up to 15 days;â?¢ Time to fever normalization (if febrile at baseline)Timepoint: within 15 days;â?¢ Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline)Timepoint: within 15 days;â?¢ Time to normalization of inflammatory markers e.g. CRP, Ferritin, d_Dimer, procalcitonin, IL2, IL6, Interferon α etc (if positive at baseline)Timepoint: within 15 days;â?¢ Time to the alleviation of nasal/throat/chest symptomsTimepoint: From the time of randomization until the time of absence of nasal/throat/chest symptoms, assessed up to 15 days | — |
Countries
India
Contacts
Public ContactDr Rakesh Rawal
Gujarat University
Outcome results
None listed