COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51849

Anirban Roy Chowdhury

anirban.roychowdhury@bharatserums.com

2021-02-25

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

1. Age <br/ >Phase 1: â?¥ 18 years to â?¤ 55 years <br/ >Phase 2: â?¥ 18 years to â?¤ 65 years <br/ >2. Are male or non-pregnant females who agree to contraceptive requirements. <br/ >3. Patients with RT-PCR confirmed COVID-19 in â?¤ 72 hours prior to randomization [Ct â?¥ 24]. <br/ >4. Have SpO2 <94% (range 90-93%) on room air. <br/ >5. Have one or more of the following- dyspnea, fever, cough, respiratory rate â?¥ 24 per minute and heart rate up to 120 per minute. <br/ >6. Patients who agree to participate in the study and follow all study related procedures

1. Require mechanical ventilation <br/ >2. Have oxygen saturation less than or equal to 89 percent <br/ >3. Patients re-infected with SARS-CoV-2 <br/ >4. Suspected or proven serious active bacterial fungal viral or other infection <br/ >5.Patients with positive skin test with IP <br/ >6. Patients with known equine allergies or past medical history of serum sickness <br/ >7. Patient who are HIV, HCV, HbsAg positive or immunocompromised <br/ >8. Patients with significant co-morbidities at screening <br/ >9. Moribund state <br/ >10. Pregnant or nursing women <br/ >11. Participating in other clinical trial

2

Bharat Serums and Vaccines ltd

18

65

India

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

160

Phase 1 <br/ >Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration <br/ > <br/ >Phase 2 <br/ >Proportion (percent) of patients turning COVID-19 negative Day 5 and Day 7Timepoint: Phase 1 <br/ >Baseline through Day 28 <br/ > <br/ >Phase 2 <br/ >Day 5 and Day 7

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

Phase 1/Phase 2

[{"arm_notes": "5 mg/kg or 10 mg/kg body weight. It is administered as a single dose intravenously after diluting in 100 -150 ml saline", "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"}]