Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Artemisinin 500mg capsule: Oral administration of Artemisinin 500 mg capsule/day for 5 days + SOC per cycle with the option to repeat as needed until disease is resolved or subject is d
Sponsors
Windlas Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects of >=18 to 60 years of age both inclusive 2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 3.Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale 4.Time interval between symptoms onset and randomization of no more than 7 days 5.One or more of the following symptoms: Fever Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste 6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening 2. Known or suspected hypersensitivity to Artemisinin 3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study 4. Men who are unwilling to use contraception while receiving investigational product 5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol 6. Subjects with history of severe renal and hepatic impairment. (creatine >=2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN) 7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days 8. Known history of failure to control systemic fungal, bacterial or viral infection 9. Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome 10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection 11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia 12. Subjects for whom ventilator support is required at screening 13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19 14. Subjects not willing to give their informed consent to participate in the clinical trial 15. According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject 16. Using other experimental drugs or participating in other clinical trials in the prior one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessments - Adverse events (AEs) during the study - Serious adverse events (SAEs) during the studyTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale. -Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms.Timepoint: Day 28 | — |
Countries
India
Contacts
Public ContactMukesh Kumar
Abiogenesis Clinpharm Private Limited
Outcome results
None listed