Phase IV study to evaluate the safety and efficacy of Artemisinin- a herbal supplement on COVID-19 subjects
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/09/028044
- Lead Sponsor
- Windlas Biotech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Assessments <br/ ><br>- Adverse events (AEs) during the study <br/ ><br>- Serious adverse events (SAEs) during the studyTimepoint: Day 28
- Secondary Outcome Measures
Name Time Method Efficacy <br/ ><br>-Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale. <br/ ><br>-Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms.Timepoint: Day 28