A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19
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Sự miêu tả
STUDY OBJECTIVES This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19.
STUDY TREATMENT AND DESIGN 50 adult patients who suffer from COVID-19 infection, and do not participant in any other clinical trial.
Patient must agree to not participate in any new clinical study during the study duration.
ArtemiC is a medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration.
It has a current status as a food supplement. Patients will receive up to 12 mg Artemisinin, 40 mg Curcumin, 30 mg Frankincense and 120 mg vitamin C in 2ml as a total maximum dose, given as add-on therapy, comprised of 2 daily doses of 0.5 ml each, on Days 1 and 2. Each dose contains 0.5 ml (total 1 ml daily dose), which is equal to 5 pushes on the spray bottle.
Placebo, composed of the same solvent but without active ingredients, will be given as add-on therapy in the placebo group, 2 times a day, on Days 1 and 2.
Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care.
The study will last 2 weeks. During this time, patients will be monitored for adverse events.
Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy.
STUDY PROCEDURES
Evaluation of the effect of oral administration of the study drug will be assessed by determining the clinical and laboratory tests as summarized below:
Biochemistry Blood Test: Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL, LDL, Triglycerides), D-dimer, ESR as well as Troponin as required.It will be performed per institutional schedule.
Hematology Blood Test: complete CBC. It will be performed per institutional schedule.
Vital signs: blood pressure, pulse, weight, height, temperature. It will be performed per institutional schedule.
Women of childbearing potential must undergo a urine pregnancy test. Physical examination: It will be performed per institutional schedule. All the above measurements will be performed by the hospital staff, not necessarily by the principal investigator or the sub-investigators.
Day 1 Prior to engaging in any study procedures, the subject must meet the inclusion/exclusion criteria by history (which includes a declination), and review and sign an ICF. Following procedures will be performed during the visit -
- Inclusion/Exclusion criteria evaluation
- ICF
- Medical history
- Concomitant medication
- Physical examination
- Vital signs
- Urine pregnancy test (if relevant)
- Test for detection of COVID-19
- Hematology blood test
- Biochemistry blood test
- Randomization (2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care) and study drug administration
Day 2
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Hematology blood test
- Biochemistry blood test
- Study drug administration
Days 3-14
- Concomitant medication
- Adverse Events assessment
- Physical examination-is per institutional schedule
- Vital signs- is per institutional schedule
- Hematology blood test- is per institutional schedule
- Biochemistry blood test- is per institutional schedule
Follow up - Hospital Discharge
- Concomitant medication
- Adverse Events assessment
- Physical examination
- Vital signs
- Test for detection COVID-19
- Hematology blood test
- Biochemistry blood test
ngày
| Xác minh lần cuối: | 04/30/2020 |
| Đệ trình đầu tiên: | 05/06/2020 |
| Đăng ký ước tính đã được gửi: | 05/06/2020 |
| Đăng lần đầu: | 05/10/2020 |
| Cập nhật lần cuối được gửi: | 06/02/2020 |
| Cập nhật lần cuối đã đăng: | 06/03/2020 |
| Ngày bắt đầu nghiên cứu thực tế: | 05/07/2020 |
| Ngày hoàn thành chính ước tính: | 07/30/2020 |
| Ngày hoàn thành nghiên cứu ước tính: | 07/30/2020 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Drug: ArtemiC
Drug: PLACEBO
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Experimental: ArtemiC Active study treatment + Standard care | Drug: ArtemiC Treatment will be sprayed orally twice a day for the first 2 days in the treatment period |
| Placebo Comparator: PLACEBO Placebo + Standard care | Drug: PLACEBO Treatment will be sprayed orally twice a day for the first 2 days in the treatment period |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
| Giới tính đủ điều kiện để nghiên cứu | All |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: 1. Confirmed SARS-CoV-2 infection. 2. Hospitalized COVID-19 patient in stable moderate condition (i.e., not requiring ICU admission). 3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient). Exclusion Criteria: 1. Tube feeding or parenteral nutrition. 2. Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening. 3. Respiratory decompensation requiring mechanical ventilation. 4. Uncontrolled diabetes type 2. 5. Autoimmune disease. 6. Pregnant or lactating women. 7. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints. |
Kết quả
Các biện pháp kết quả chính
1. Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of [24 hours]
2. Percentage of participants with definite or probable drug related adverse events [14 days]
Các biện pháp kết quả thứ cấp
1. Time to negative COVID-19 PCR [14 days]
2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms [14 days]
3. COVID-19 related survival [14 days]
4. Incidence and duration of mechanical ventilation [14 days]
5. Incidence of Intensive Care Init (ICU) stay [14 days]
6. Duration of ICU stay [14 days]
7. Duration of time on supplemental oxygen [14 days]
