Clinical research on safety and efficacy of ZingiVir-H as an add on therapy in COVID-19 patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/04/024883
- Lead Sponsor
- Pankajakasthuri herbal research foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 116
1. Patients of both sexes aged from 18 years to 60 years old.
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-CoV)-2 infection
confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours
before randomization
4. Currently hospitalized and requiring medical care for COVID-19
5. Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
6. Radiographic evidence of pulmonary infiltrates
Candidates for the study will be excluded if ANY of the following criteria are present:
1. Subject or Authorized Representative is unable to provide informed consent
2. Subject is pregnant or breastfeeding ladies
3. Subject is of childbearing potential and has a positive pregnancy test since admission to
the hospital
4. Subject is < 18 years of age
5. Subject has a known allergy to herbal compounds or ZingiVir-H or any components of
the drug product
6. Subject has had previous treatment with ZingiVir-H
7. Body weight >= 175 kg
8. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing
impairment of hemostasis as a result of one of these procedures
9. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of
bleeding.
10. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM),
cerebral aneurysm, or mass lesions of the central nervous system or melena,
hematemesis.
11. Inability to take oral medication
12. Prolonged QTc-interval in baseline ECG ( >500 ms)
13. History of solid organ, allogeneic bone marrow, or stem cell transplantation.
14. Severe renal failure characterized by chronic or acute need of hemodialysis,
hemofiltration or peritoneal dialysis
15. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the
treatment period.
16. Participation in another research study involving an investigational agent within 30 days prior to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method