Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Equine Anti Covid Antibody Fragments F(ab�)2 in addition to SOC: 3ml vial will be supplied for each patient that need to be diluted in 100ml NS and will be given at rate of 1ml/m
Sponsors
VINS BioProducts Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female subjects of age 18-65 years (both inclusive) 2.Subjects with documented laboratory confirmed COVID-19 infection with positive qualitative reverse transcriptaseââ?¬â??polymerase chain reaction (RT-PCR) 3.Criteria for diagnosis of moderate COVID disease - Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 4.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative serum pregnancy test 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. 6.Not participating in any other interventional drug clinical studies before completion of the present trial 7.Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 8.Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 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 2.Subjects of COVID-19 disease, less than 18 years old 3.History of anaphylaxis 4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) 5.Subjects who have received or require treatment with convalescent plasma. 6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. 7.Other disease conditions: i.Medical history of Oncological Conditions since last 2 years ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) 8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. 9.Medical conditions that would limit subjectââ?¬•s participation in the study as per Investigatorââ?¬•s judgement. 10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. 11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. 12.Receipt of pooled immunoglobulin in last 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Primary Endpoint(s) - Safety Incidence of Serious Adverse Events Incidence of Treatment Emergent Adverse Events Incidence of related Serious Adverse Events Incidence of Grade 3 or 4 (severe) Adverse events Phase II Primary Endpoint(s) - Efficacy 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. Timepoint: 30 days 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary outcome- Secondary Safety Endpoint(s) Phase II: Incidence of Serious Adverse Events Incidence of Treatment Emergent Adverse Events Incidence of Grade 3 and above (severe) Adverse events Incidence of related Serious Adverse Events Other Secondary End Points- Secondary Efficacy Endpoint(s) Phase I and Phase II: Clinical recovery rate [Time Frame: Day 14] Timepoint: Upto 4 weeks Upto 4 weeks | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed