CTRI/2020/05/025434招募中4 期
Randomized, double-blind, placebo-controlledprospective multicenter trial to validate thesafety and efficacy of an antiviral drugzingivir-h, in adults with asymptomatic, mild ormoderate nCOVID-19 infection.
Pankajakasthuri herbal research foundation0 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
- 4 期
- 状态
- 招募中
- 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 Patients of both sexes aged from 18 years to 60 years old.
- •2 Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures
- •3.Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID infection confirmed by RT Polymerase chain reaction RT-PCR test
- •a PCR positive in sample collected 96 hours prior to randomization OR
- •b PCR positive in sample collected 96 hours prior to randomization documented inability to obtain a repeat sample e.g. due to lack of testing supplies limited testing capacity results taking 24 hours or any other documented reasons etc. AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •4.Currently hospitalized and requiring medical care for COVID-19
- •5.Peripheral capillary oxygen saturation SpO2 94 percentage on room air at screening
- •6.Radiographic evidence of pulmonary infiltrates OPTIONAL Criteria
排除标准
- •1.Any of the following would exclude the subject from participation in the study:
- •2.Subject or Authorized Representative is unable to provide informed consent
- •3.Subject is pregnant or breastfeeding ladies
- •4.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital
- •5.Acute illness (defined as the presence of moderate or severe signs and symptoms related with the COVID infection) at the time of randomization
- •6.Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator)
- •7.History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study
- •8.Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
- •9.History of CLD/ bronchopulmonary dysplasia
- •10.Clinically significant congenital anomaly of the respiratory tract
- •11.Inability to take oral medication
- •12.Prolonged QTc-interval in baseline ECG ( >500 ms)
- •13.Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis
- •14.Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period.
- •15.Participation in another research study involving an investigational agent within 30 days prior to consent
- •16.Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
研究者
相似试验
进行中（未招募）
不适用
Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.mild to moderate ulcerative colitisMedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-002462-20-ITDR. AUGUST WOLFF GMBH & CO. KG160
进行中（未招募）
不适用
Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisEUCTR2011-002462-20-PLDr August Wolff GmbH & Co KG Arzneimittel160
进行中（未招募）
不适用
Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisEUCTR2011-002462-20-HUDr August Wolff GmbH & Co KG Arzneimittel
进行中（未招募）
不适用
Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisAcute mild to moderate ulcerative colitis.MedDRA version: 14.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-002462-20-SKDr August Wolff GmbH & Co KG Arzneimittel
进行中（未招募）
不适用
Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitisAcute mild to moderate ulcerative colitis.MedDRA version: 14.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856EUCTR2011-002462-20-CZDr August Wolff GmbH & Co KG Arzneimittel