Evaluation of Efficacy and Safety of Thymoquinone compared to Best supportive care in Patients with COVID-19

Phase 2

Recruiting

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2020/05/025167

Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Ability to provide signed and dated informed consent.

2. Male or female aged >= 18 and <=65 years of age.

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 <72 hours prior to enrollment; AND

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 <20, HR <90, oxygen saturation (pulse oximetry) >93% on room air at screening.

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 <90 mmHg or Diastolic BP < 60 mm Hg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support

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.