COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55706

Dr M V Khadilkar

drhjs@seruminstitute.com

2021-06-24

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Adult Male or Female patients aged 18 to 45 years (both Inclusive) <br/ > <br/ >2. Patients with COVID-19 disease confirmed by RT-PCR at screening. The latest RT-PCR test result should be within 3 days prior to randomization/ first dose of investigational product <br/ >3. Patients with a COVID-19 disease whose first symptom onset is â?¤ 7 days from first dose of investigational product <br/ >4.Patients requiring hospitalization for treatment of COVID-19 infection and who fulfil a score of either 4 or 5 on the WHO 10-point Progression Scale at randomization/prior to administration of first dose of IP <br/ >5.Oxygen saturation (SPO2) between 90% to 93% (both inclusive) on room air at randomization/ prior to administration of first dose of IP <br/ >6.Capable and willing to provide written informed consent prior to the performance of any study- specific procedures.

1.Patients with known allergies to equine serum or to any component of Equine antiserum <br/ >2.Patients with past medical history of Serum Sickness <br/ >3.Patients with history of anaphylaxis or severe allergic reactions to a vaccine, food, drug, toxin or other exposure <br/ >4.Patients who have received convalescent plasma or immunoglobulin for COVID-19 disease <br/ >5.Patients who have received convalescent plasma or immunoglobulin for conditions other than COVID-19 disease within 3 months prior to first dose of investigational product <br/ >6.Patients who are admitted in the Intensive Care Unit (ICU) or under invasive mechanical ventilation and/or extracorporeal membrane oxygenation at randomization/prior to first dose of investigational product <br/ >7.Patients with severe COVID-19 disease including those with severe pneumonia, moderate to severe Acute Respiratory Distress Syndrome, Sepsis and/or Organ failure <br/ >8.Patients who are expected to be referred to another institution within 72 hours of enrolment, which prevents proper follow-up of that patient <br/ >9.Patients whose progression to death due to COVID-19 disease is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment as assessed by the Investigator <br/ >10.Pregnant or breastfeeding women <br/ >11.Known history of human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody. <br/ >12.Participating in any other study and have received any other investigational medication or device within 30 days prior to randomization or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study. <br/ >13.Any other medical condition which in the opinion of the Investigator may affect the patientsâ?? safety or study participation and conduct <br/ >14.Presence of any other severe/uncontrolled concurrent medical condition other than COVID-19 disease which precludes the patient from study participation in the interest of patient safety, as judged by the Investigator. <br/ >15.Receipt of ant COVID-19 vaccine (Licensed/EUL/under trial) <br/ >16.Patients re-infected with SARS-CoV-2/COVID-19 disease. <br/ >

2

Serum Institute of India Pvt Ltd

18

45

India

Severe disease at enrollment

6: Severe disease at enrollment

40

â?¢ To assess the safety of COVID-19 Antiserum when administered as three doses; 24 hours apart; in adult patients aged 18-45 years with SARS-COV-2/COVID- 19 disease.Timepoint: Through Day 28/EOS

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

Phase 1

[{"arm_notes": "", "treatment_id": 474, "treatment_name": "Equine covid-19 antiserum [f(ab')2]", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]