COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57079

Dr Jayashri Krishnan

sanjana.dawra@jssresearch.com

2021-06-22

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Male or Female subjects of age 18-65 years (both inclusive) <br/ >2.Subjects with documented laboratory confirmed COVID-19 infection with positive qualitative reverse transcriptaseâ??polymerase chain reaction (RT-PCR) <br/ >3.Criteria for diagnosis of moderate COVID disease - Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <93% (range 90-93%) on room air, Respiratory Rate more or equal to 24-30 per minute OR on low flow oxygen (up to 6 litres per minute to maintain saturation above 93%) <br/ >4.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative serum pregnancy test <br/ >5.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the trial period and for at least 30 days following the last day of trial treatment administered. <br/ >6.Not participating in any other interventional drug clinical studies before completion of the present trial <br/ >7.Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening. <br/ >8.Subjects willing to comply with the protocol requirements. <br/ >

1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ >2.Subjects of COVID-19 disease, less than 18 years old <br/ >3.History of anaphylaxis <br/ >4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ >5.Subjects who have received or require treatment with convalescent plasma. <br/ >6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >7.Other disease conditions: <br/ >i.Medical history of Oncological Conditions since last 2 years <br/ >ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ >iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ >8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ >9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ >10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ >11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ >12.Receipt of pooled immunoglobulin in last 90 days

2

VINS BioProducts Limited

18

65

India

Severe disease at enrollment

6: Severe disease at enrollment

212

Phase I <br/ >Primary Endpoint(s) - Safety <br/ >Incidence of Serious Adverse Events <br/ >Incidence of Treatment Emergent Adverse Events <br/ >Incidence of related Serious Adverse Events <br/ >Incidence of Grade 3 or 4 (severe) Adverse events <br/ > <br/ >Phase II <br/ >Primary Endpoint(s) - Efficacy <br/ >Time to Clinical recovery (TTCR) [Day 1 through Day 14] for which Day of recovery is defined as the first day on which the subject shows 2 point improvement in the ordinal scale. <br/ > <br/ >Timepoint: 30 days <br/ > <br/ >14 days

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

Phase 1/Phase 2

[{"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"}]