Status:
UNKNOWN
The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients
Lead Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Covid19
Eligibility:
All Genders
19+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacy of pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19). Pyronaridine-artesunate ha...
Detailed Description
\<Stage 1\> In Stage 1, the trial will be conducted in 20 participants for 28 days in a single arm, open-label design. Artecom® will be administered orally once a day for 3 consecutive days. All subje...
Eligibility Criteria
Inclusion
- Male and female adults age (≥19 years at the time of informed consent)
- Body weight (≥ 45 kg at Screening)
- Participants must be confirmed as having COVID-19 using real-time reverse transcription polymerase chain reaction (RT-PCR) test and specimens collected from upper airway (nasopharyngeal specimen) within 96 hours prior to randomization.
- Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow-up period. Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period.
- Hormonal contraception (with approved oral contraceptives, long-acting implantable hormones, injectable hormones), intra uterine device, condoms , sterilization (vasectomy, tubal occlusion, etc.)
Exclusion
- Participants with clinically significant cardiovascular disease (including arrhythmia, corrected QT interval prolongation \[QTcF\> 470 msec for females, or \>450 msec for males, at Screening\])
- Participants with clinically significant anemia (Hemoglobin \<8.0 g/dL)
- Participants who have hypersensitivity to main ingredients (pyronaridine tetraphosphate, artesunate) and any excipient in the IP
- Participants who have gastrointestinal disease or surgical participant that may affect absorption, distribution, metabolism and excretion of drugs, current active gastritis, gastrointestinal /rectal bleeding, gastric ulcers, pancreatic abnormalities such as pancreatitis, etc. (simple appendectomy or hernia surgery not excluded)
- Participants who have received antiviral drugs for the treatment of COVID-19 infection or other indications within 28 days prior to participation in the study or who have not had sufficient wash-out period of the antiviral drugs
- Participants with severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
- Participants with severe hepatic impairment (Alanine aminotransferase or Aspartate aminotransferase ≥5x upper limit of normal) or have symptoms of abdominal pain or vomiting associated with Jaundice or Child-Pugh Stage B or C
- Viral infections other than COVID-19 that requires administration of other antiviral agents (for example but not limited to human immunodeficiency virus, hepatitis B virus, hepatitis C virus)
- Participants requiring mechanical ventilation (e.g. non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation etc.). However, those who can be given oral administration are not exdluded.
- Participants with chronic underlying diseases (such as uncontrolled diabetes, chronic kidney disease, chronic liver disease, chronic lung disease \[including asthma, chronic obstructive pulmonary disease and tuberculosis\], chronic cardiovascular disease, blood cancer, cancer participants with anti-cancer treatment, participants taking immunosuppressants, etc.), participants with high obesity (BMI \> 40), dialysis participants, transplant participants whom are inadequate to participate in clinical trials based on the Investigator's discretion.
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- Participants who participated in another clinical trial / medical device clinical trial within 28 days from the date of signing the consent and received drug / operated medical device for clinical trial.
- Participants who the Investigator has deemed inappropriate for inclusion in this study for any other reason.
- Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2022
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04701606
Start Date
March 29 2021
End Date
April 15 2022
Last Update
September 30 2021
Active Locations (4)
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1
De La Salle University Medical Center
Dasmariñas, Gov, D. Mangubat St, 4114 Cavite, Philippines
2
The Medical City
Pasig, Ortigas Avenue, Barangay Ugong, Metro Manila, Philippines
3
Lung Center of the Philippines
Quezon City, Quezon Avenue, Quezon City, 1100 Philippines, Philippines
4
Philippine General Hospital
Manila, Taft Ave, Ermita, Manila, 1000 Metro, Philippines