Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: SARS-CoV-2 (COVID-19) Antiserum
Immunoglobulins (Purified F(ab)2 fragment along with standard of
care: Patients in this group will receive two 4mL
doses (at day 0 and Day 1) of BioEâ??s
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female patients aged between 18-55 years who signed the informed consent. 2. Patients screened for Covid-19 by RT-PCR method of RT-PCR confirmation and/or 7 days from the start of symptoms. 3. Respiratory Rate > 24 breaths/min and SpO2 4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.
Exclusion criteria
Exclusion criteria: 1.Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products and reactive to intradermal sensitivity test prior to infusion 4. Receipt of pooled immunoglobulin in last 30 days 5. Critically ill patients: a. Severe ARDS cases b. Shock (Requiring Vasopressor to maintain a MAP >= 65mmHg or MAP below 65) 6. Participating in any other clinical trial 7. Clinical status precluding infusion of blood products 8. Patients are not suitable for transfusion therapy; 9. Patients with severe pneumonia defined as: RR >=30 times/min or oxygen saturation resting state or PaO2/FiO2 respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with presence of other organ failure; 10. Acute life-threatening organ dysfunction caused by a dys-regulated host response to suspected or proven infection. (Signs of organ dysfunction include: altered mental status, difficult or fast breathing, low oxygen saturation, reduced urine output, fast heart rate, weak pulse, cold extremities or low blood pressure, skin mottling, or laboratory evidence of coagulopathy, thrombocytopenia, acidosis, high lactate or hyperbilirubinemia). 11. Patients on any other immunoglobulin or immunomodulatory treatment; 12. Patients with known history of allergy to horse proteins or severe allergic reactions to any component of the Equine antiserum;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with treatment-emergent adverse events including infusion related reactionsTimepoint: Day 0 Through Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality rateTimepoint: at Day 28.;Change in oxygen requirementTimepoint: Post Infusion;Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive VentilationTimepoint: Post Enrolment;Levels of bio-markers (CRP, IL6, LDH, Ferritin & D-Dimer)Timepoint: pre and post infusion;Proportion of patients with clinical progression of disease on a WHO clinical progression scaleTimepoint: assessed up to Day 28.;Proportion of patients with RT-PCR negative outcomeTimepoint: At Day 14 and Day 28;Time to symptom resolution a) Fever b) Shortness of Breath c) FatigueTimepoint: post enrolment | — |
Countries
India
Contacts
Public ContactDr Kishore TSA
Biological E.Limited
Outcome results
None listed