CTRI/2020/11/028779进行中（未招募）1 期
A phase I, open label, parallel, randomised trial to assess the safety and efficacy of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease in addition to standard of care. - None
Biological ELimited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Both male and female patients aged between 18-55 years who signed the informed consent.
- •2. Patients screened for Covid-19 by RT-PCR method <=72 hours from the date
- •of RT-PCR confirmation and/or 7 days from the start of symptoms.
- •3. Respiratory Rate > 24 breaths/min and SpO2 <=93% on room air
- •4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.
排除标准
- •1.Pregnant women
- •2. Breastfeeding women
- •3. Known hypersensitivity to blood products and reactive to intradermal
- •sensitivity test prior to infusion
- •4. Receipt of pooled immunoglobulin in last 30 days
- •5. Critically ill patients:
- •a. Severe ARDS cases
- •b. Shock (Requiring Vasopressor to maintain a
- •MAP >= 65mmHg or MAP below 65)
- •6. Participating in any other clinical trial
- •7. Clinical status precluding infusion of blood
- •8. Patients are not suitable for transfusion
- •9. Patients with severe pneumonia defined as: RR
- •>=30 times/min or oxygen saturation <= 90% in
- •resting state or PaO2/FiO2 <= 100 mmHg or
- •respiratory failure and mechanical ventilation
- •are required or shock occurs or ICU
- •monitoring with presence of other organ
- •10. Acute life-threatening organ dysfunction
- •caused by a dys-regulated host response to
- •suspected or proven infection. (Signs of organ
- •dysfunction include: altered mental status,
- •difficult or fast breathing, low oxygen
- •saturation, reduced urine output, fast heart
- •rate, weak pulse, cold extremities
- •or low blood pressure, skin mottling, or
- •laboratory evidence of coagulopathy,
- •thrombocytopenia, acidosis, high lactate or
- •hyperbilirubinemia).
- •11. Patients on any other immunoglobulin or
- •immunomodulatory treatment;
- •12. Patients with known history of allergy to
- •horse proteins or severe allergic reactions
- •to any component of the Equine antiserum;
研究者
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