Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012892855610 Date of Approval: 17/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19
Official scientific title A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19
Brief summary describing the background and objectives of the trial The escalating outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is stretching health systems globally beyond comprehension. The ensuing corona virus disease 2019 (COVID-19) has become a challenging source of morbidity and mortality across the globe. Current technical guide is related to address therapeutic option for SARS-CoV-2. COVID-19 is great challenge for scientist across the globe. Bioactive compound present in Artemisia such as Artemisinin has anti -viral activities against hepatitis B virus, bovine viral diarrhea virus, Epstein-Barr virus, and SARS-CoV-1 that occured in 2002. This agent is cheap and easily available and has been postulated to be effective against COVID-19- the disease caused by SARS- CoV-2.7 We and others have shown that Artemesinin is active in vitro against SARS-CoV-2 8. This clinical trial is to evaluate the effectiveness of Artemisinin- an active isolated from a number of Artemisia species including Artemesia annua, Artemisia apiacea, Artemisia lancea, Artemisia cina and in aerial parts of Artemisia sieberi. Presence of artemisinin has also been reported in Artemisia absinthium, Artemisia dubia and Artemisia indica. However little is known about the role of Artemisinin when used as a standalone or co-administered with the currently being evaluated therapy for treatment of COVID-19. Given the promising therapeutic strategy of downregulating TGF -β for COVID-19 patients, and that artemisinin is commonly used herbal remedy worldwide, we set out to evaluate artemisinin in COVID-19 patients, to determine whether it is an effective treatment option for these patients. Objectives Primary Objective: • To observe and evaluate safety of Artemisinin- a herbal supplement on COVID-19 subjects Secondary objective: • To observe and evaluate efficacy of Artemisinin- a herbal supplement on COVID-19 subjects
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Corona Virus COVID-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/12/2020
Actual trial start date
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemisinin group Artemisinin 500 mg capsule/day for 5 days and SOC per cycle Four weeks Artemisinin 500 mg capsule/day for 5 days and SOC per cycle 80
Control Group Standard of Care Standard of care given timely 4 weeks Standard of care. All the patients in that arm will receive standard of care. 40 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or female subjects of ≥18 to 60 years of age. 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 following co-morbidities: insulin-dependent diabetes, hypertension with cardiac symptoms, morbid obesity with diabetes and/or hypertension 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 Subjects having uncontrolled diabetes, uncontrolled hypertension. 16. According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the subject 17. Using other experimental drugs or participating in other clinical trials in the prior one month. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2020 University of Abuja Teaching Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Gwagwalada-Kubwa road Gwagwalada 900271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Adverse events (AEs) during the study 4 weeks
Primary Outcome Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale 4 weeks
Secondary Outcome Serious adverse events (SAEs) during the study 4 weeks
Secondary Outcome Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms. 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Abuja Teaching Hospital Gwagwalada Gwagwalada-Zuba, Gwagwalada Gwagwalada Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oncotelic Incorporated 29397 Agoura Road, Suite 107, Agoura Hills CA 91301 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Nnamdi Azikiwe University PMB 5025 Nnewi Nigeria University
Primary Sponsor Oncotelic Incorporated Oncotelic Inc., 29397 Agoura Road, Suite 107, Agoura Hills CA 91301 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof Mustapha Abubakar Jamda College of Health Sciences, University of Abuja Abuja Nigeria
Prof Charles Esimone Office of the Vice Chancellor, Nnamdi Azikiwe University Awka Nigeria
Prof Joseph Ikechebelu Nnamdi Azikiwe University Awka Nigeria
Dr George Chukwuma Nnamdi Azikiwe University Nnewi Nigeria
Prof Festus Okoye Nnamdi Azikiwe University Awka Nigeria
Prof Henrietta Ogbunugafor Nnamdi Azikiwe University Awka Nigeria
Dr Obinna Ekwunife Grant Office, Nnamdi Azikiwe University Awka Nigeria
Dr Kenneth Ngwoke Nnamdi Azikiwe University Awka Nigeria
Dr George Eleje Office of Deputy Director, Research and Innovations, Nnamdi Azikiwe University Awka Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Esimone co.esimone@unizik.edu.ng +2348062835781 Office of the Vice Chancellor, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria Vice Chancellor
Role Name Email Phone Street address
Scientific Enquiries George Eleje georgel21@yahoo.com +2348068117444 Office of Deputy Director, Research and innovations. Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Nigeria Deputy Director
Role Name Email Phone Street address
Public Enquiries Elijah Sokomba esokomba@yahoo.com +2348033185715 No 1 JB Leton close, Off Dan Isokrari close, Off Abdullahi Ibrahim Crescent.
City Postal code Country Position/Affiliation
Abuja Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data (IPD) summary results All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol September 2021 to December 2021 Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information