Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Thymoquinone 50 mg tablet as an add on to best supportive as per guidelines of clinical management of COVID-19 as issued by MOHFW.: Dose : 50 mg once daily for 14 days
Control Intervent
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ability to provide signed and dated informed consent. 2. Male or female aged >= 18 and 3. Patients who meets the following criteria: a. With confirmed COVID-19 infection as defined below i. Has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) or other commercial or public health assay in any specimen, collected ii. Asymptomatic patients without any signs or symptoms as defined in clinical management guidelines for COVID-19 infection issued by the Ministry of Health and Family Welfare (MOHFW); OR Mild (uncomplicated) illness of any duration not requiring hospitalization, and without extreme shortness of breath or severe prostration meeting following criteria: 1. Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND 2. No signs of any serious lower airway disease as defined in clinical management guidelines for COVID-19 infection issued by MOHFW AND 3. RR 93% on room air at screening.
Exclusion criteria
Exclusion criteria: 1. Severe COVID-19 including but not limited to: a. respiratory failure (defined by endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations) b. Multiple organ dysfunction/failure c. Systolic BP 2. Confirmed or suspected diagnosis of Acute Respiratory Distress Syndrome (ARDS) at screening 3. History of severe chronic respiratory disease and requirement for long-term oxygen therapy 4. Expected need for mechanical ventilation within the next 24 hours 5. Expected survival of less than 96 hours at the time of presentation 6. Receiving renal replacement therapy/dialysis 7. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies 8. Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry 9. Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline 10. Patients who have received organ transplantation or major surgery in the past 6 months. 11. Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or Patients with child-Pugh grade C cirrhosis. 12. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the Patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize virologic and clinical response of Thymoquinone in patients diagnosed with COVID-19 Timepoint: 1. Virologic outcome a. Change in positive COVID-19 status on day 8 and day 15 2. Clinical outcomes a. Proportion of Patients on WHO progression scale 0 to 10 on day 8 and day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients who are exposed to the Lipid based ThymoquinoneTimepoint: 1.Clinical Outcomes a.Change from baseline in COVID-19 symptom severity at day 8 and day 15. 2.Immunological outcomes on Day 1, Day 8 and Day 15 after drug administration 3 Safety Endpoints: throughout the study | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed