Trial · NCT04532931

Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19

NCT04532931, Phase 2, Completed, Shin Poong Pharmaceutical Co. Ltd.; results first posted 2025-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19. Trials, record NCT04532931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04532931

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19
NCT number: NCT04532931
Status: Completed
Phases: Phase 2
Enrollment: 192 participants, actual
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Conditions: COVID-19
Interventions: Paracetamol, Artesunate-amodiaquine, Pyronaridine-artesunate, Favipiravir plus Nitazoxanide, Sofosbuvir/daclatasvir
First posted: 2020-08-31
Last updated: 2025-07-28
Results first posted: 2025-07-28

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of SARS-CoV-2 Clearance	Day 7
Secondary	Incidence of SARS-CoV-2 Clearance	Day 3, 10, 14, 21, 28
Secondary	Time to Clearance of Nasal SARS-CoV-2	Day 0, 3, 7, 10, 14, 21, 28
Secondary	Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR	Day 14	baseline and day14, Day 14 value minus baseline value
Secondary	Poisson Regression for Proportion of Days With Fever After Randomization	Day 28
Secondary	Percentage of Days With Respiratory Symptoms After Randomization	from randomization to end of study (until day 28)	"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"
Secondary	FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days	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)
Secondary	Serious Adverse Events	Day 28
Secondary	Adverse Events	Day 28
Secondary	Related Adverse Events	Day 28

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Incidence of SARS-CoV-2 Clearance	Day 7	percentage of paticaipants	NUMBER
SECONDARY	Incidence of SARS-CoV-2 Clearance	Day 3, 10, 14, 21, 28	percentage of paticaipants	NUMBER
SECONDARY	Time to Clearance of Nasal SARS-CoV-2	Day 0, 3, 7, 10, 14, 21, 28	Time(day)	MEDIAN
SECONDARY	Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR	Day 14	Log₁₀ copies/mL	MEAN
SECONDARY	Poisson Regression for Proportion of Days With Fever After Randomization	Day 28	proportion	NUMBER
SECONDARY	Percentage of Days With Respiratory Symptoms After Randomization	from randomization to end of study (until day 28)	Percentage (%)	MEAN
SECONDARY	FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days	14 days	score	MEDIAN
SECONDARY	Serious Adverse Events	Day 28	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	Day 28	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Related Adverse Events	Day 28	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group95

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of SARS-CoV-2 Clearance	Arm A		34.2	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm B		38.5	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm C		30.3	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm D		27.0	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm E		23.5	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm A	Day 3	28.2	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm B	Day 3	17.9	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm C	Day 3	17.1	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm D	Day 3	24.3	percentage of paticaipants
Incidence of SARS-CoV-2 Clearance	Arm E	Day 3	14.3	percentage of paticaipants

1 to 10 of 95Source ClinicalTrials.gov

See all 95 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Paracetamol (SOC)	39
Overall Study	STARTED	SOC Plus Artesunate-Amodiaquine	39
Overall Study	STARTED	SOC Plus Favipiravir Plus Nitazoxanide	38
Overall Study	STARTED	SOC Plus Pyronaridine-Artesunate	38
Overall Study	STARTED	SOC Plus Sofosbuvir/Daclatasvir	38
Overall Study	COMPLETED	Paracetamol (SOC)	37
Overall Study	COMPLETED	SOC Plus Artesunate-Amodiaquine	39
Overall Study	COMPLETED	SOC Plus Favipiravir Plus Nitazoxanide	36
Overall Study	COMPLETED	SOC Plus Pyronaridine-Artesunate	36
Overall Study	COMPLETED	SOC Plus Sofosbuvir/Daclatasvir	35

1 to 10 of 15Source ClinicalTrials.gov

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Adverse events95

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	nausea	Gastrointestinal disorders	SOC (Paracetamol)	2	39	2
other	nausea	Gastrointestinal disorders	ASAQ	6	39	6
other	nausea	Gastrointestinal disorders	PA(Pyronaridine-Artesunate)	4	38	4
other	nausea	Gastrointestinal disorders	FPV-NTZ	8	36	8
other	nausea	Gastrointestinal disorders	SOF/DCV	4	36	4
other	diarrhea	Gastrointestinal disorders	SOC (Paracetamol)	5	39	5
other	diarrhea	Gastrointestinal disorders	ASAQ	3	39	3
other	diarrhea	Gastrointestinal disorders	PA(Pyronaridine-Artesunate)	3	38	3
other	diarrhea	Gastrointestinal disorders	FPV-NTZ	7	36	7
other	diarrhea	Gastrointestinal disorders	SOF/DCV	4	36	4

1 to 10 of 95Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SOC (Paracetamol)	0	39
Total, all-cause mortality	ASAQ	0	39
Total, all-cause mortality	PA(Pyronaridine-Artesunate)	0	38
Total, all-cause mortality	FPV-NTZ	0	36
Total, all-cause mortality	SOF/DCV	0	36
Total, other adverse events	SOC (Paracetamol)	14	39
Total, other adverse events	ASAQ	18	39
Total, other adverse events	PA(Pyronaridine-Artesunate)	21	38
Total, other adverse events	FPV-NTZ	31	36
Total, other adverse events	SOF/DCV	16	36

1 to 10 of 15Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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