Effect of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/028779
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <=72 hours from the date
of RT-PCR confirmation and/or 7 days from the start of symptoms.
3. Respiratory Rate > 24 breaths/min and SpO2 <=93% on room air
4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.
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 <= 90% in
resting state or PaO2/FiO2 <= 100 mmHg or
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with treatment-emergent adverse events including infusion related reactionsTimepoint: Day 0 Through Day 28
- Secondary Outcome Measures
Name Time Method All cause mortality rateTimepoint: at Day 28.;Change in oxygen requirementTimepoint: Post Infusion;Duration of respiratory support required <br/ ><br>a. Duration of Invasive Mechanical Ventilation <br/ ><br>b. Duration of Non-Invasive VentilationTimepoint: Post Enrolment;Levels of bio-markers (CRP, IL6, LDH, Ferritin & D-Dimer)Timepoint: pre and post <br/ ><br>infusion;Proportion of patients with clinical progression of disease on a WHO <br/ ><br>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 <br/ ><br>a) Fever <br/ ><br>b) Shortness of Breath <br/ ><br>c) FatigueTimepoint: post enrolment