Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Equine COVID-19 Antiserum [F(ab)2] Along with Standard of care.: The Dose of the IP is 1ml diluted in 100ml NS will be administered as an IV infusion. Total 3 doses with an interval of
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult Male or Female patients aged 18 to 45 years (both Inclusive) 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 3. Patients with a COVID-19 disease whose first symptom onset is 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 5.Oxygen saturation (SPO2) between 90% to 93% (both inclusive) on room air at randomization/ prior to administration of first dose of IP 6.Capable and willing to provide written informed consent prior to the performance of any study- specific procedures.
Exclusion criteria
Exclusion criteria: 1.Patients with known allergies to equine serum or to any component of Equine antiserum 2.Patients with past medical history of Serum Sickness 3.Patients with history of anaphylaxis or severe allergic reactions to a vaccine, food, drug, toxin or other exposure 4.Patients who have received convalescent plasma or immunoglobulin for COVID-19 disease 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 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 7.Patients with severe COVID-19 disease including those with severe pneumonia, moderate to severe Acute Respiratory Distress Syndrome, Sepsis and/or Organ failure 8.Patients who are expected to be referred to another institution within 72 hours of enrolment, which prevents proper follow-up of that patient 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 10.Pregnant or breastfeeding women 11.Known history of human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody. 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. 13.Any other medical condition which in the opinion of the Investigator may affect the patientsâ?? safety or study participation and conduct 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. 15.Receipt of ant COVID-19 vaccine (Licensed/EUL/under trial) 16.Patients re-infected with SARS-CoV-2/COVID-19 disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To assess the efficacy 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 7 and Day 28/EOS | — |
Countries
India
Contacts
Public ContactDr M V Khadilkar
Serum Institute of India Pvt. Ltd.
Outcome results
None listed