Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Immunoglobulin and standard of care: Dose:0.4 g/kg body weight
Frequency once in a day
Duration 5 days
Route IV route
Control Intervention1: Standard of Care: Azithromycin 500 mg once
and (ii) For patients who are unable to take medications by mouth, 400 mg lopinavir /100 mg ritonavir 5 ml suspension every 12 h for 14 days or seven days after becoming asymptomatic whichever is earl
Pantocid 40 mg tablet once a day
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Both male or female patients who signed the informed consent and aged >=18 years ; Patients admitted with RT-PCR confirmed COVID-19 illness. Patient with any of the following : Fever >=36.7â?? axilla or Oral temperature >= 38.0 â?? PaO2/ FiO2: 100-300 mmHg Respiratory Rate >24/min and SaO2 90- 93% on room air Lung involvement confirmed with chest X-ray. (X-ray interpretation as mentioned in ICMR guideline-bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules)
Exclusion criteria
Exclusion criteria: Viral pneumonia with other viruses besides COVID-19 Patients are not suitable for immunoglobulin therapy. Patients with severe pneumonia defined as : RR >= 30 times/min or oxygen saturation Patients on either immunoglobulin or hydroxychloroquine treatment Pregnant or lactating women or other circumstances in which the investigator determined that the patient is not suitable for the clinical trial. Participation in other studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days to clinical improvement. It is defined as no. of days from initiation of treatment day to discharge day on a six-category ordinal scale Timepoint: 0-28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical improvement Number of deaths during the follow-up of 28 days (28 days mortality). Incidence or duration of mechanical ventilation from day 0 to 28 Duration of hospitalization from day 0 to 28. Incidence and duration of stay in ICU from day 0 to 28. Proportion of patients with negative RT-PCR on day 14, on day 28 (or end of the study period). Timepoint: 0-28 days | — |
Countries
India
Contacts
Public ContactDr Aditi
Virchow Biotech Private Limited
Outcome results
None listed