A Phase I, Randomized, Controlled, Open Label Study to Assess the Safety and Efficacy of COVID-19 Antiserum in Adult Patients with SARS-CoV-2/COVID-19 Disease. - SII-COVID19-EqS/IN-01

Serum Institute of India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Serum Institute of India Pvt Ltd

研究概览入排标准研究者记录与标识符相似试验

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.Adult Male or Female patients aged 18 to 45 years (both Inclusive)
•2. Patients with COVID-19 disease confirmed by RT-PCR at screening. The latest RT-PCR test result should be within 3 days prior to randomization/ first dose of investigational product
•3. Patients with a COVID-19 disease whose first symptom onset is <= 7 days from first dose of investigational product
•4.Patients requiring hospitalization for treatment of COVID-19 infection and who fulfil a score of either 4 or 5 on the WHO 10-point Progression Scale at randomization/prior to administration of first dose of IP
•5.Oxygen saturation (SPO2) between 90% to 93% (both inclusive) on room air at randomization/ prior to administration of first dose of IP
•6.Capable and willing to provide written informed consent prior to the performance of any study- specific procedures.

排除标准

•1.Patients with known allergies to equine serum or to any component of Equine antiserum
•2.Patients with past medical history of Serum Sickness
•3.Patients with history of anaphylaxis or severe allergic reactions to a vaccine, food, drug, toxin or other exposure
•4.Patients who have received convalescent plasma or immunoglobulin for COVID-19 disease
•5.Patients who have received convalescent plasma or immunoglobulin for conditions other than COVID-19 disease within 3 months prior to first dose of investigational product
•6.Patients who are admitted in the Intensive Care Unit (ICU) or under invasive mechanical ventilation and/or extracorporeal membrane oxygenation at randomization/prior to first dose of investigational product
•7.Patients with severe COVID-19 disease including those with severe pneumonia, moderate to severe Acute Respiratory Distress Syndrome, Sepsis and/or Organ failure
•8.Patients who are expected to be referred to another institution within 72 hours of enrolment, which prevents proper follow-up of that patient
•9.Patients whose progression to death due to COVID-19 disease is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment as assessed by the Investigator
•10.Pregnant or breastfeeding women
•11.Known history of human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody.
•12.Participating in any other study and have received any other investigational medication or device within 30 days prior to randomization or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
•13.Any other medical condition which in the opinion of the Investigator may affect the patientsâ?? safety or study participation and conduct
•14.Presence of any other severe/uncontrolled concurrent medical condition other than COVID-19 disease which precludes the patient from study participation in the interest of patient safety, as judged by the Investigator.
•15.Receipt of ant COVID-19 vaccine (Licensed/EUL/under trial)
•16.Patients re-infected with SARS-CoV-2/COVID-19 disease.

研究者

发起方

Serum Institute of India Pvt Ltd

相似试验

进行中（未招募）

1 期

A study evaluating the clinical benefit of Cemiplimab versus Cemiplimab in combination with RP1 in patients with skin cancerAdvanced Cutaneous Squamous Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10077314Term: Skin squamous cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003964-30-PLReplimune, Inc.230

进行中（未招募）

1 期

EUCTR2018-003964-30-GRReplimune, Inc.230

进行中（未招募）

1 期

A study evaluating the clinical benefit of cemiplimab versus cemiplimab in combination with RP1 in patients with skin cancerAdvanced Cutaneous Squamous Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10077314Term: Skin squamous cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003964-30-ITReplimune, Inc.180

进行中（未招募）

1 期

EUCTR2018-003964-30-FRReplimune, Inc.240

进行中（未招募）

1 期

EUCTR2018-003964-30-BGReplimune, Inc.230