COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14510

Elijah Sokomba

esokomba@yahoo.com

2020-11-22

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

2

Oncotelic Incorporated

18

60

Nigeria

Mild disease at enrollment

1: Mild disease at enrollment

120

• Adverse events (AEs) during the study;Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 119, "treatment_name": "Artemisinin", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]