A clinical trial to evaluate the Medicinal effects of ZingiVir-H as Anti-Viral therapy in COVID-19 patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025434
- Lead Sponsor
- Pankajakasthuri herbal research foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method