A Phase 2 interventional study of Paracetamol and Artesunate-amodiaquine in COVID-19, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 1 site in South Africa. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease at the time of enrollment.
This phase 2, exploratory study will be an adaptive, randomized, open label, trial for treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety evaluation, progression to LRTI (defined by resting blood oxygen saturation level [SpO2] \<93% sustained for two readings two hours apart and presence of subjective dyspnoea or cough), disease severity, clinical resolution rate, and cumulative incidence of hospitalization or mortality at Day 28.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 192 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Signs of respiratory distress prior to randomization, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 mg oral tablets. Two tablets taken at 6-hour intervals as needed, in all treatment arms (in addition to any investigative treatment)
Drug: Paracetamol
Fixed dose combination tablets containing 100 mg artesunate and 270 mg amodiaquine. Participants received two tablets once daily for 3 days
Drug: Artesunate-amodiaquine
Fixed dose combination tablets containing 180 mg pyronaridine and 60 mg artesunate, given once daily for 3 days. Participants weighing 45 to \<65 kg received 3 tablets per dose, those ≥65 kg received 4 tablets per dose
Drug: Pyronaridine-artesunate
Free combination of favipiravir 200 mg and 400 mg tablets and nitazoxanide 500 mg tablets. Participants received favipiravir as a loading dose of 1600 mg twice daily for 1 day followed by 600 mg twice daily for 6 days, and nitazoxanide 1000 mg twice daily, with food, for 7 days
Drug: Favipiravir plus Nitazoxanide
Fixed dose combination tablets containing 400 mg sofosbuvir and 60 mg daclatasvir. Participants received 1 tablet once daily for 7 days
Drug: Sofosbuvir/daclatasvir
SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed
Also known as: Control treatment (SoC)
Drug pages: Artesunate · Amodiaquine
SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days
Also known as: ASAQ
SOC plus pyronaridine-artesunate (PA) Weight 45 to \<65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days
Also known as: PA
Drug pages: Favipiravir · Nitazoxanide
SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days
Also known as: FPV-NTZ
Drug pages: Sofosbuvir · Daclatasvir
SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Also known as: SOF/DCV
Incidence of SARS-CoV-2 Clearance
Time frame: Day 7
Incidence of SARS-CoV-2 Clearance
Time frame: Day 3, 10, 14, 21, 28
Time to Clearance of Nasal SARS-CoV-2
Time frame: Day 0, 3, 7, 10, 14, 21, 28
Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR
baseline and day14, Day 14 value minus baseline value
Time frame: Day 14
Poisson Regression for Proportion of Days With Fever After Randomization
Time frame: Day 28
Percentage of Days With Respiratory Symptoms After Randomization
"Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100"
Time frame: from randomization to end of study (until day 28)
FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days
baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus * Score range per item: 0 (no symptoms) to 4 (very severe symptoms). A higher score indicates worse symptoms. * Total score calculation: The mean (average) of all item scores is used. (Minimum score: 0, Maximum score: 4)
Time frame: 14 days
Serious Adverse Events
Time frame: Day 28
Adverse Events
Time frame: Day 28
Related Adverse Events
Time frame: Day 28
LRTI
Time frame: Day 28
Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation
Time frame: Day 28
Cumulative Incidence of Hospitalization
Time frame: Day 28
Days of Hospitalization
Total number of hospitalization days for hospitalized participants in each group
Time frame: Day 28
Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28
Time frame: at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months
| Milestone | Paracetamol (SOC) | SOC Plus Artesunate-Amodiaquine | SOC Plus Favipiravir Plus Nitazoxanide | SOC Plus Pyronaridine-Artesunate | SOC Plus Sofosbuvir/Daclatasvir |
|---|---|---|---|---|---|
| Started | 39 | 39 | 38 | 38 | 38 |
| Completed | 37 | 39 | 36 | 36 | 35 |
| Not completed | 2 | 0 | 2 | 2 | 3 |
| percentage of paticaipants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Incidence of SARS-CoV-2 Clearance | 34.2 | 38.5 | 30.3 | 27.0 | 23.5 |
| percentage of paticaipants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Day 3 | 28.2 | 17.9 | 17.1 | 24.3 | 14.3 |
| Day 10 | 33.3 | 33.3 | 40.0 | 29.7 | 34.3 |
| Day 14 | 56.4 | 51.3 | 45.7 | 51.4 | 51.4 |
| Day 21 | 66.7 | 53.8 | 68.6 | 64.9 | 68.6 |
| Day 28 | 71.8 | 66.7 | 68.6 | 73.0 | 68.6 |
| Time(day) | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Time to Clearance of Nasal SARS-CoV-2 | 10 (7 to 14) | 7 (3 to 9) | 8.5 (3 to 14) | 14 (3 to 14) | 8.5 (3 to 14) |
baseline and day14, Day 14 value minus baseline value
| Log₁₀ copies/mL | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | -3.81 ± 2.576 | -3.35 ± 2.531 | -3.30 ± 2.283 | -3.50 ± 2.691 | -2.98 ± 2.757 |
| proportion | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Poisson Regression for Proportion of Days With Fever After Randomization | 0.596 | 0.000 | 1.732 | 0.599 | 0.835 |
"Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100"
| Percentage (%) | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Percentage of Days With Respiratory Symptoms After Randomization | 35.66 (28.252 to 38.450) | 28.034 (22.134 to 30.386) | 33.469 (26.451 to 36.416) | 29.602 (23.947 to 32.937) | 35.306 (30.099 to 40.711) |
baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus * Score range per item: 0 (no symptoms) to 4 (very severe symptoms). A higher score indicates worse symptoms. * Total score calculation: The mean (average) of all item scores is used. (Minimum score: 0, Maximum score: 4)
| score | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | -0.750 ± 0.8270 | -0.750 ± 1.0046 | -0.750 ± 0.9079 | -1.250 ± 0.9135 | -0.750 ± 0.5711 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Serious Adverse Events | 0 | 0 | 0 | 1 | 0 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Adverse Events | 0 | 0 | 0 | 1 | 1 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Related Adverse Events | 0 | 11 | 12 | 21 | 10 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| LRTI | 0 | 0 | 2 | 0 | 1 |
| score | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | 1 ± 0.5 | 0 ± 0.6 | 1 ± 0.76 | 1 ± 0.43 | 1 ± 0.81 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Cumulative Incidence of Hospitalization | 0 | 0 | 1 | 0 | 1 |
Total number of hospitalization days for hospitalized participants in each group
| Days | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Days of Hospitalization | 0 ± 0 | 0 ± 0 | 6.00 ± 0 | 0 ± 0 | 6.00 ± 0 |
| Participants | Arm A | Arm B | Arm C | Arm D | Arm E |
|---|---|---|---|---|---|
| Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | 0 | 0 | 0 | 0 | 0 |
Collected over Day 28 and up to 3 months after end of study treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOC (Paracetamol) | 0/39 (0%) | 0/39 (0%) | 14/39 (35.9%) |
| ASAQ | 0/39 (0%) | 0/39 (0%) | 18/39 (46.2%) |
| PA(Pyronaridine-Artesunate) | 0/38 (0%) | 0/38 (0%) | 21/38 (55.3%) |
| FPV-NTZ | 0/36 (0%) | 1/36 (2.8%) | 31/36 (86.1%) |
| SOF/DCV | 0/36 (0%) | 0/36 (0%) | 16/36 (44.4%) |
| Event | SOC (Paracetamol) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV |
|---|---|---|---|---|---|
| PancytopeniaBlood and lymphatic system disorders | 0/39 | 0/39 | 0/38 | 1/36 | 0/36 |
| Event | SOC (Paracetamol) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV |
|---|---|---|---|---|---|
| ChromaturiaRenal and urinary disorders | 0/39 | 0/39 | 1/38 | 11/36 | 0/36 |
| DizzinessNervous system disorders | 4/39 | 2/39 | 9/38 | 4/36 | 3/36 |
| nauseaGastrointestinal disorders | 2/39 | 6/39 | 4/38 | 8/36 | 4/36 |
| Abdominal painGastrointestinal disorders | 2/39 | 2/39 | 4/38 | 8/36 | 2/36 |
| diarrheaGastrointestinal disorders | 5/39 | 3/39 | 3/38 | 7/36 | 4/36 |
| VomitingGastrointestinal disorders | 4/39 | 5/39 | 5/38 | 2/36 | 1/36 |
| HeadacheNervous system disorders | 0/39 | 3/39 | 2/38 | 3/36 | 3/36 |
| Upper respiratory tract infectionInfections and infestations | 0/39 | 0/39 | 3/38 | 0/36 | 1/36 |
| Back painMusculoskeletal and connective tissue disorders | 0/39 | 3/39 | 0/38 | 2/36 | 0/36 |
| InsomniaPsychiatric disorders | 0/39 | 3/39 | 1/38 | 0/36 | 0/36 |
| Age, Categorical(Participants) | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 1 | 0 | 0 | 1 |
| Between 18 and 65 years | 39 | 39 | 35 | 37 | 35 | 185 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| Mean | 33.7 ± 9.93 | 36 ± 10.32 | 35.9 ± 11.28 | 34 ± 9.43 | 34.8 ± 10.58 | 34.9 ± 10.25 |
| Sex: Female, Male(Participants) | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| Female | 24 | 25 | 20 | 15 | 15 | 99 |
| Male | 15 | 14 | 16 | 22 | 20 | 87 |
| Race (NIH/OMB)(Participants) | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 3 | 0 | 1 | 1 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 36 | 32 | 34 | 32 | 31 | 165 |
| White | 1 | 2 | 2 | 2 | 1 | 8 |
| More than one race | 0 | 2 | 0 | 2 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Paracetamol (SOC) | ASAQ | PA(Pyronaridine-Artesunate) | FPV-NTZ | SOF/DCV | Total |
|---|---|---|---|---|---|---|
| South Africa — Black African | 36 | 32 | 34 | 32 | 31 | 165 |
| South Africa — Coloured | 0 | 2 | 0 | 2 | 2 | 6 |
| South Africa — White | 1 | 2 | 2 | 2 | 1 | 8 |
| South Africa — Asian or Indian | 2 | 3 | 0 | 1 | 1 | 7 |
| South Africa — Other | 0 | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Artesunate · Amodiaquine · Favipiravir · Nitazoxanide · Sofosbuvir · Daclatasvir
Shin Poong Pharmaceutical Co. Ltd. →