COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48578

Dr Kishore TSA

kishore.turaga@biologicale.com

2020-11-02

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Both male and female patients aged between 18-55 years who signed the informed consent. <br/ >2. Patients screened for Covid-19 by RT-PCR method â?¤72 hours from the date <br/ >of RT-PCR confirmation and/or 7 days from the start of symptoms. <br/ >3. Respiratory Rate > 24 breaths/min and SpO2 â?¤93% on room air <br/ >4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.

1.Pregnant women <br/ >2. Breastfeeding women <br/ >3. Known hypersensitivity to blood products and reactive to intradermal <br/ >sensitivity test prior to infusion <br/ >4. Receipt of pooled immunoglobulin in last 30 days <br/ >5. Critically ill patients: <br/ > a. Severe ARDS cases <br/ > b. Shock (Requiring Vasopressor to maintain a <br/ > MAP â?¥ 65mmHg or MAP below 65) <br/ >6. Participating in any other clinical trial <br/ >7. Clinical status precluding infusion of blood <br/ > products <br/ >8. Patients are not suitable for transfusion <br/ > therapy, <br/ >9. Patients with severe pneumonia defined as: RR <br/ > â?¥30 times/min or oxygen saturation â?¤ 90% in <br/ > resting state or PaO2/FiO2 â?¤ 100 mmHg or <br/ > respiratory failure and mechanical ventilation <br/ > are required or shock occurs or ICU <br/ > monitoring with presence of other organ <br/ > failure, <br/ >10. Acute life-threatening organ dysfunction <br/ > caused by a dys-regulated host response to <br/ > suspected or proven infection. (Signs of organ <br/ > dysfunction include: altered mental status, <br/ > difficult or fast breathing, low oxygen <br/ > saturation, reduced urine output, fast heart <br/ > rate, weak pulse, cold extremities <br/ > or low blood pressure, skin mottling, or <br/ > laboratory evidence of coagulopathy, <br/ > thrombocytopenia, acidosis, high lactate or <br/ > hyperbilirubinemia). <br/ >11. Patients on any other immunoglobulin or <br/ > immunomodulatory treatment, <br/ >12. Patients with known history of allergy to <br/ > horse proteins or severe allergic reactions <br/ > to any component of the Equine antiserum,

2

Biological ELimited

18

55

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

72

Proportion of patients with treatment-emergent adverse events including infusion related reactionsTimepoint: Day 0 Through Day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "", "treatment_id": 1152, "treatment_name": "Sars-cov-2 equine antiserum immunoglobulin (purified f(ab)2 fragment)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]