CTRI/2021/06/034334已完成1 期
A prospective, randomized, multicentric, comparative Phase I/ Phase II clinical trial to evaluate the clinical safety, efficacy and tolerability of Equine Anti Covid Antibody Fragments F(ab�)2 as an add on therapy to Standard of Care (SOC) in comparison to SOC alone in hospitalized adult subjects with COVID-19 infection, with moderate severity.
VINS BioProducts Limited0 个研究点目标入组 217 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 <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%)
- •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.
排除标准
- •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
研究者
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