An open label observational study on post covid complications and radiological pattern changes on those patients treated with ZingiVir H .
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/11/029025
- 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
Patients of both sexes aged 18 years and older.
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 Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID19
infection confirmed by RT Polymerase chain reaction RT-PCR test
PCR positive in sample collected lesser than 96 hours prior to enrollment;
Currently hospitalized and requiring medical care for COVID-19 atleast ONE of the
following co-morbid risk factor
Age above 60 years
Documented history of coronary artery disease
Heart failure New York Heart Association Class 3 or 4
Hypertension, requiring at least 1 prescription medicine for management.
Dyslipidemia, requiring at least 1 prescription medicine for management.
Chronic lung disease eg, asthma or chronic obstructive pulmonary disease requiring
treatment
Documented history of stroke
Diabetes mellitus, requiring at least 1 prescription medicine for management
Documented chronic kidney disease with an estimated glomerular filtration rate lesser than 30
mL/min, not on dialysis
Obesity Class 2 or 3 body mass index greater than 34.9 kg per m2)
History of Chronic Kidney disease
Oxygen saturation between 90 and 95% with or without supplemental oxygen
Willing to cooperate with investigation team on study procedures including Radiographic
assessments during the study period.
Any of the following would exclude the subject from participation in the study:
Subject or Authorized Representative is unable to provide informed consent
Subject is pregnant or breastfeeding ladies
Subject is of childbearing potential and has a positive pregnancy test since admission to
the hospital
Acute Respiratory Distress illness which is defined as the presence of critical signs and
symptoms related with the COVID infection as per WHO criteria on severity at the time
of enrollment
History of receipt of blood transfusion or immunoglobulin products or expected receipt
through the duration of the study
Severe hepatic dysfunction like liver cirrhosis
Clinically significant congenital anomaly of the respiratory tract
Inability to take oral medication
Prolonged QTc-interval in baseline ECG ( >500 ms)
Severe renal failure characterized by chronic or acute need of hemodialysis,
hemofiltration or peritoneal dialysis
Participation in another research study involving an investigational agent within 30 days
prior to consent
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 Radiographic changes in lungs evaluated by Chest computed tomography scan <br/ ><br>Radiographic changes in brain evaluated by Brain computed tomography scanTimepoint: 0,15,30 days
- Secondary Outcome Measures
Name Time Method Proportion of Participants experiencing Treatment-Emergent Adverse Events Grade 3 <br/ ><br>and 4 clinical and/or laboratory adverse events (AEs) <br/ ><br>Changes in the CT Chest scan before and after treatment. <br/ ><br>Changes in the CT Brain scan before and after treatment. <br/ ><br>Signal variations in the Electro cardio gram (ECG) and Electro Encephalo gram (EEG) <br/ ><br>before and after treatment. <br/ ><br>Forced Vital Capacity (FVC) <br/ ><br>Forced Expiratory Volume in 1 second (FEV1) <br/ ><br>Timepoint: 0,15,30 days