Covid19Phase 2/3PROVIDENCENCT04701606
The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients
A Phase 2/3 study testing Artecom® (pyronaridine-artesunate) in people with Covid19, run by Shin Poong Pharmaceutical Co. Ltd. at 4 sites in Philippines.
Trial 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 has been approved in Europe, Asia and Africa under brand name of Pyramax® or Artecom® as a treatment for malaria. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Artecom® (pyronaridine-artesunate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 4 sitesPhilippines
- Study dates
- 29 Mar 2021to 15 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Philippines4 sites, 4 recruiting
- Recruiting
De La Salle University Medical Center
Dasmariñas, Gov, D. Mangubat St, 4114 Cavite
Oscar Ferdinand D Feliciano, MD. PhD
Oscar Ferdinand D Feliciano, MD. PhD
- Recruiting
Philippine General Hospital
Manila, Taft Ave, Ermita, Manila, 1000 Metro
Belen L Dofitas, MD, PhD
Belen L Dofitas, MD, PhD
- Not yet recruiting
The Medical City
Pasig, Ortigas Avenue, Barangay Ugong, Metro Manila
Manuel Hector U Silos, MD. PhD
Manuel Hector U Silos, MD. PhD
- Recruiting
Lung Center of the Philippines
Quezon City, Quezon Avenue, Quezon City, 1100 Philippines
Lawrence O Raymond, MD, PhD
Lawrence O Raymond, MD, PhD
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine-artesunate (Artecom®) in COVID-19 Patients
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 has been approved in Europe, Asia and Africa under brand name of Pyramax® or Artecom® as a treatment for malaria. The study will be conducted in two stages: open-label (Stage 1) and double-blind (Stage 2).
Up to approximately 402 participants (20 participants in Stage 1 and 382 participants in Stage 2) are planned to be enrolled in the study and will be randomized to receive either Artecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will be determined by the participant's body weight, according to previously established guidelines.
Read more
An independent Drug Safety Monitoring Board (DSMB) will be established to review the safety at regular intervals during the conduct of the trial. The DSMB will be subject to a Charter and will review after 20 participants have been recruited, and thereafter when 191 participants have been recruited.
Ad-hoc DSMB meetings may be held at any time during the study if there are any major safety concerns. A final DSMB will be conducted when all participants have been recruited in the trial.
Read the 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 subjects will be evaluated for efficacy and safety for 28 days.
After the completion of the final participant in Stage 1, the DSMB will review the safety data from Stage 1 and determine whether to proceed to Stage 2.
<Stage 2> In Stage 2, a total of 382 participants will be enrolled and randomized in a double blinded manner to receive either Artecom® or placebo (1:1 ratio) orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.
A second DSMB meeting and review of all available blinded safety data will occur after 191 participants have completed Day 28. A final DSMB meeting will be held after the completion of a study assessment by the last participant.
- Conditions
- Covid19
- Being tested
- Artecom® (pyronaridine-artesunate), Placebo
- Keywords
- Pyramax, COVID-19, pyronaridine-artesunate, SARS-CoV-2, Artecom
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artecom® (pyronaridine-artesunate)Drug
Also called Pyramax® (pyronaridine-artesunate)
- Participant body weight (Artecom® dose)
- ≥ 65kg (Artecom® 4 tablets: Pyronaridine 720mg/ Artesunate 240mg)
- ≥ 45kg and < 65kg (Artecom® 3 tablets: Pyronaridine 540mg/ Artesunate 180mg)
PlaceboDrug
- Participant body weight (Placebo dose)
- ≥ 65kg (Placebo 4 tablets)
- ≥ 45kg and < 65kg (Placebo 3 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Artecom® (pyronaridine-artesunate) | Experimental | Artecom® is treated orally once a day for 3 consecutive days. Receives: Drug: Artecom® (pyronaridine-artesunate) |
| Placebo | Placebo comparator | Placebo is treated orally once a day for 3 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with clinical improvement as defined by an improvement of categories on the WHO Ordinal Scale of clinical status until Days 28.
- WHO Ordinal scale: 0. No clinical or virological evidence of infection
- No limitation of activities
- Limitation of activities
- Hospitalized, no oxygen therapy
- Oxygen by mask or nasal prongs
- Non-invasive ventilation or high-flow oxygen
- Intubation and mechanical ventilation
- Ventilation + additional organ support - Pressers, Renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)
- Death
Measured: follows up to 28 days
Secondary outcomes (12)
Time to clinical improvement was defined as time from randomization to an improvement of categories on the WHO Ordinal Scale of clinical status.
Clinical improvement within 28 days since start of treatment, defined as a decrease of at least 2 point from baseline of a nine-point WHO ordinal scale.
Measured: follows up to 28 days
Changes in the WHO Ordinal Scale for Clinical Improvement until Days 28 compared to Baseline.
Compare statistical results of an increase or decrease in a nine-point WHO ordinal scale between two groups.
Measured: follows up to 28 days
Changes in National Early Warning Score (NEWS) until Days 28 compared to Baseline.
NEWS determines the degree of illness of a patient and promotes critical care intervention. The score range from 0-20, with a higher score representing a higher risk of morbidity. Compare statistical results of an increase or decrease in NEWS between two groups.
Measured: follows up to 28 days
Proportion of participants with negative for COVID-19 as determined by real-time RT-PCR test until Days 14.
Proportion of subjects who are RT-PCR negative for COVID-19
Measured: follows up to 14 days
Changes in viral load until Days 14 compared to Baseline.
Viral load reduction of COVID-19 until Days 14 compared to the baseline.
Measured: follows up to 14 days
The time to body temperature normalization after the administration of investigational Product (IP).
Maintaining underarm ≤36.7 °C, or oral ≤36.9°C, or rectal ≤37.3°C, or eardrum ≤37.2°C, for at least 24 hours without administering fever reducing medication after the administration of IP.
Measured: follows up to 28 days
The time to respiratory rate normalization after the administration of IP.
Maintain 12/min ≤ respiratory rate ≤ 20/min for at least 24 hours.
Measured: follows up to 28 days
The time to oxygen saturation (SpO2) normalization after the administration of IP.
SpO2 ≥95% for at least 24 hours.
Measured: follows up to 28 days
Mortality rate at Day 28.
Compare the mortality rate between two groups.
Measured: Day 28
Duration of hospitalization (Day 1 to Day 28).
Number of days the subject from the start of treatment to hospital discharge.
Measured: follows up to 28 days
The incidence of adverse events (AEs).
The incidence rate of adverse events
Measured: follows up to 28 days
The incidence of serious adverse events (SAEs).
The incidence rate of serious adverse events
Measured: follows up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start29 Mar 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Stage 1: Single Group (Experimental drug only) * Stage 2: Parallel (Placebo control and Experimental drug)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belen L Dofitas, MD, PhD, Principal investigator, Philippine General Hospital, University of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701606
- Sponsor's protocol ID
- SP-PA-COV-203
- Acronym
- PROVIDENCE
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine-artesunate (Artecom®) in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04701606
- Acronym / sponsor ID
- PROVIDENCE / SP-PA-COV-203
- Conditions
- Covid19
- Keywords
- Pyramax, COVID-19, pyronaridine-artesunate, SARS-CoV-2, Artecom
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 has been approved in Europe, Asia and Africa under brand name of Pyramax® or Artecom® as a treatment for malaria. The study will be conducted in two stages: open-label (Stage 1) and double-blind (Stage 2).
Up to approximately 402 participants (20 participants in Stage 1 and 382 participants in Stage 2) are planned to be enrolled in the study and will be randomized to receive either Artecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will be determined by the participant's body weight, according to previously established guidelines.
An independent Drug Safety Monitoring Board (DSMB) will be established to review the safety at regular intervals during the conduct of the trial. The DSMB will be subject to a Charter and will review after 20 participants have been recruited, and thereafter when 191 participants have been recruited.
Ad-hoc DSMB meetings may be held at any time during the study if there are any major safety concerns. A final DSMB will be conducted when all participants have been recruited in the trial.
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 subjects will be evaluated for efficacy and safety for 28 days.
After the completion of the final participant in Stage 1, the DSMB will review the safety data from Stage 1 and determine whether to proceed to Stage 2.
<Stage 2> In Stage 2, a total of 382 participants will be enrolled and randomized in a double blinded manner to receive either Artecom® or placebo (1:1 ratio) orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.
A second DSMB meeting and review of all available blinded safety data will occur after 191 participants have completed Day 28. A final DSMB meeting will be held after the completion of a study assessment by the last participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- * Stage 1: Single Group (Experimental drug only) * Stage 2: Parallel (Placebo control and Experimental drug)
| Arm | Type | Receives |
|---|---|---|
| Artecom® (pyronaridine-artesunate) | Experimental | Drug: Artecom® (pyronaridine-artesunate)Artecom® is treated orally once a day for 3 consecutive days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is treated orally once a day for 3 consecutive days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artecom® (pyronaridine-artesunate)Also: Pyramax® (pyronaridine-artesunate)* Participant body weight (Artecom® dose) * ≥ 65kg (Artecom® 4 tablets: Pyronaridine 720mg/ Artesunate 240mg) * ≥ 45kg and < 65kg (Artecom® 3 tablets: Pyronaridine 540mg/ Artesunate 180mg) | Drug | Artecom® (pyronaridine-artesunate) |
| Placebo* Participant body weight (Placebo dose) * ≥ 65kg (Placebo 4 tablets) * ≥ 45kg and < 65kg (Placebo 3 tablets) | Drug | Placebo |
Primary outcome
Proportion of participants with clinical improvement as defined by an improvement of categories on the WHO Ordinal Scale of clinical status until Days 28.
Time frame: follows up to 28 days
* WHO Ordinal scale: 0. No clinical or virological evidence of infection 1. No limitation of activities 2. Limitation of activities 3. Hospitalized, no oxygen therapy 4. Oxygen by mask or nasal prongs 5. Non-invasive ventilation or high-flow oxygen 6. Intubation and mechanical ventilation 7. Ventilation + additional organ support - Pressers, Renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. Death
12 secondary outcomes
Time to clinical improvement was defined as time from randomization to an improvement of categories on the WHO Ordinal Scale of clinical status.
Time frame: follows up to 28 days
Changes in the WHO Ordinal Scale for Clinical Improvement until Days 28 compared to Baseline.
Time frame: follows up to 28 days
Changes in National Early Warning Score (NEWS) until Days 28 compared to Baseline.
Time frame: follows up to 28 days
Proportion of participants with negative for COVID-19 as determined by real-time RT-PCR test until Days 14.
Time frame: follows up to 14 days
Changes in viral load until Days 14 compared to Baseline.
Time frame: follows up to 14 days
The time to body temperature normalization after the administration of investigational Product (IP).
Time frame: follows up to 28 days
The time to respiratory rate normalization after the administration of IP.
Time frame: follows up to 28 days
The time to oxygen saturation (SpO2) normalization after the administration of IP.
Time frame: follows up to 28 days
Mortality rate at Day 28.
Time frame: Day 28
Duration of hospitalization (Day 1 to Day 28).
Time frame: follows up to 28 days
The incidence of adverse events (AEs).
Time frame: follows up to 28 days
The incidence of serious adverse events (SAEs).
Time frame: follows up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belen L Dofitas, MD, PhD principal investigator
Philippine General Hospital, University of the Philippines
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Artecom® (pyronaridine-artesunate) in people with Covid19, run by Shin Poong Pharmaceutical Co. Ltd. at 4 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belen L Dofitas, MD, PhD (+63-917-629-4329, belendofitas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinical improvement as defined by an improvement of categories on the WHO Ordinal Scale of clinical status until Days 28. (time frame: follows up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.