Phase IV study to evaluate the safety and efficacy of Artemisinin- a herbal supplement on COVID-19 subjects

Phase 4

Recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/09/028044
• Lead Sponsor: Windlas Biotech Private Limited

Brief Summary

This will be an open label, prospective, multi-center, comparative, interventional study to evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate COVID-19.

Initially subjects having mild to moderate COVID-19 will be screened as per predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio. Group 1 will have 80 subjects and Group 2 will have 40 subjects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-10
• Study Start: 2020-09-30

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

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

• 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.
• 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	Day 28
- Adverse events (AEs) during the study	Day 28
- Serious adverse events (SAEs) during the study	Day 28

Secondary Outcome Measures

Name	Time	Method
Efficacy	-Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale.

Trial Locations

Locations (3)

Government Medical College & Government General Hospital, Srikakulam; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Rajarshi Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Seven Star Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Medical College & Government General Hospital, Srikakulam

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr K Sunil Naik

Principal investigator

8942279033

rimsresearch@gmail.com