Trial Outcomes & Findings for Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 (NCT NCT04532931)

NCT ID: NCT04532931

Last Updated: 2025-07-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 192 participants
• Primary outcome timeframe: Day 7
• Results posted on: 2025-07-28

Participant Flow

Participant milestones

Measure	Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	SOC Plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	SOC Plus Favipiravir Plus Nitazoxanide Favipiravir plus 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	SOC Plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	SOC Plus Sofosbuvir/Daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Overall Study STARTED	39	39	38	38	38
Overall Study COMPLETED	37	39	36	36	35
Overall Study NOT COMPLETED	2	0	2	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment

Baseline characteristics by cohort

Measure	Paracetamol (SOC) n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	ASAQ n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	PA(Pyronaridine-Artesunate) n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	FPV-NTZ n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	SOF/DCV n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days	Total n=186 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	39 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	35 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	37 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	35 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	185 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Age, Categorical >=65 years	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Age, Continuous	33.7 years STANDARD_DEVIATION 9.93 • n=5 Participants	36 years STANDARD_DEVIATION 10.32 • n=7 Participants	35.9 years STANDARD_DEVIATION 11.28 • n=5 Participants	34 years STANDARD_DEVIATION 9.43 • n=4 Participants	34.8 years STANDARD_DEVIATION 10.58 • n=21 Participants	34.9 years STANDARD_DEVIATION 10.25 • n=8 Participants
Sex: Female, Male Female	24 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	25 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	20 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	15 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	15 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	99 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Sex: Female, Male Male	15 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	14 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	16 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	22 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	20 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	87 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) Asian	2 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	3 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	7 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	32 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	34 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	32 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	31 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	165 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) White	1 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	8 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	6 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Region of Enrollment South Africa · Black African	36 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	32 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	34 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	32 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	31 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	165 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Region of Enrollment South Africa · Coloured	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	6 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Region of Enrollment South Africa · White	1 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	2 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	8 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Region of Enrollment South Africa · Asian or Indian	2 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	3 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	1 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	7 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment
Region of Enrollment South Africa · Other	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=7 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=5 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=4 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=21 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment	0 Participants n=8 Participants • Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment

PRIMARY outcome

Timeframe: Day 7

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Incidence of SARS-CoV-2 Clearance	34.2 percentage of paticaipants	38.5 percentage of paticaipants	30.3 percentage of paticaipants	27.0 percentage of paticaipants	23.5 percentage of paticaipants

SECONDARY outcome

Timeframe: Day 3, 10, 14, 21, 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Incidence of SARS-CoV-2 Clearance Day 28	71.8 percentage of paticaipants	66.7 percentage of paticaipants	68.6 percentage of paticaipants	73.0 percentage of paticaipants	68.6 percentage of paticaipants
Incidence of SARS-CoV-2 Clearance Day 3	28.2 percentage of paticaipants	17.9 percentage of paticaipants	17.1 percentage of paticaipants	24.3 percentage of paticaipants	14.3 percentage of paticaipants
Incidence of SARS-CoV-2 Clearance Day 10	33.3 percentage of paticaipants	33.3 percentage of paticaipants	40.0 percentage of paticaipants	29.7 percentage of paticaipants	34.3 percentage of paticaipants
Incidence of SARS-CoV-2 Clearance Day 14	56.4 percentage of paticaipants	51.3 percentage of paticaipants	45.7 percentage of paticaipants	51.4 percentage of paticaipants	51.4 percentage of paticaipants
Incidence of SARS-CoV-2 Clearance Day 21	66.7 percentage of paticaipants	53.8 percentage of paticaipants	68.6 percentage of paticaipants	64.9 percentage of paticaipants	68.6 percentage of paticaipants

SECONDARY outcome

Timeframe: Day 0, 3, 7, 10, 14, 21, 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Time to Clearance of Nasal SARS-CoV-2	10 Time(day) Interval 7.0 to 14.0	7 Time(day) Interval 3.0 to 9.0	8.5 Time(day) Interval 3.0 to 14.0	14 Time(day) Interval 3.0 to 14.0	8.5 Time(day) Interval 3.0 to 14.0

SECONDARY outcome

Timeframe: Day 14

baseline and day14, Day 14 value minus baseline value

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR	-3.81 Log₁₀ copies/mL Standard Deviation 2.576	-3.35 Log₁₀ copies/mL Standard Deviation 2.531	-3.30 Log₁₀ copies/mL Standard Deviation 2.283	-3.50 Log₁₀ copies/mL Standard Deviation 2.691	-2.98 Log₁₀ copies/mL Standard Deviation 2.757

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Poisson Regression for Proportion of Days With Fever After Randomization	0.596 proportion	0.000 proportion	1.732 proportion	0.599 proportion	0.835 proportion

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Percentage of Days With Respiratory Symptoms After Randomization	35.66 Percentage (%) Interval 28.252 to 38.45	28.034 Percentage (%) Interval 22.134 to 30.386	33.469 Percentage (%) Interval 26.451 to 36.416	29.602 Percentage (%) Interval 23.947 to 32.937	35.306 Percentage (%) Interval 30.099 to 40.711

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days	-0.750 score Standard Deviation 0.8270	-0.750 score Standard Deviation 1.0046	-0.750 score Standard Deviation 0.9079	-1.250 score Standard Deviation 0.9135	-0.750 score Standard Deviation 0.5711

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=38 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=36 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=36 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Serious Adverse Events	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Adverse Events	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Related Adverse Events	0 Participants	11 Participants	12 Participants	21 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
LRTI	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation	1 score Standard Deviation 0.5	0 score Standard Deviation 0.6	1 score Standard Deviation 0.76	1 score Standard Deviation 0.43	1 score Standard Deviation 0.81

SECONDARY outcome

Timeframe: Day 28

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Cumulative Incidence of Hospitalization	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 28

Total number of hospitalization days for hospitalized participants in each group

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Days of Hospitalization	0 Days Standard Deviation 0	0 Days Standard Deviation 0	6.00 Days Standard Deviation 0	0 Days Standard Deviation 0	6.00 Days Standard Deviation 0

SECONDARY outcome

Timeframe: at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months

Outcome measures

Measure	Arm A n=39 Participants Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	Arm B n=39 Participants SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	Arm C n=36 Participants SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	Arm D n=37 Participants SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	Arm E n=35 Participants SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

SOC (Paracetamol)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ASAQ

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

PA(Pyronaridine-Artesunate)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

FPV-NTZ

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

SOF/DCV

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	SOC (Paracetamol) n=39 participants at risk Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	ASAQ n=39 participants at risk SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	PA(Pyronaridine-Artesunate) n=38 participants at risk SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	FPV-NTZ n=36 participants at risk SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	SOF/DCV n=36 participants at risk SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Blood and lymphatic system disorders Pancytopenia	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.8% 1/36 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.

Other adverse events

Measure	SOC (Paracetamol) n=39 participants at risk Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed	ASAQ n=39 participants at risk SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days	PA(Pyronaridine-Artesunate) n=38 participants at risk SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: 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	FPV-NTZ n=36 participants at risk SOC plus Favipiravir plus Nitazoxanide Favipiravir plus 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	SOF/DCV n=36 participants at risk SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Gastrointestinal disorders nausea	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	15.4% 6/39 • Number of events 6 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	10.5% 4/38 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	22.2% 8/36 • Number of events 8 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	11.1% 4/36 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders diarrhea	12.8% 5/39 • Number of events 5 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.7% 3/39 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.9% 3/38 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	19.4% 7/36 • Number of events 7 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	11.1% 4/36 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	10.5% 4/38 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	22.2% 8/36 • Number of events 8 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders Vomiting	10.3% 4/39 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	12.8% 5/39 • Number of events 5 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	13.2% 5/38 • Number of events 5 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.8% 1/36 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders Constipation	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.8% 1/36 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders Mouth ulceration	2.6% 1/39 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.3% 2/38 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Gastrointestinal disorders Haemorrhoids	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Infections and infestations Upper respiratory tract infection	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.9% 3/38 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.8% 1/36 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.7% 3/39 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Nervous system disorders Dizziness	10.3% 4/39 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	23.7% 9/38 • Number of events 9 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	11.1% 4/36 • Number of events 4 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	8.3% 3/36 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Nervous system disorders Headache	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.7% 3/39 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.3% 2/38 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	8.3% 3/36 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	8.3% 3/36 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Psychiatric disorders Insomnia	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	7.7% 3/39 • Number of events 3 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.6% 1/38 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Renal and urinary disorders Chromaturia	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	2.6% 1/38 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	30.6% 11/36 • Number of events 12 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 1/39 • Number of events 1 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.6% 2/36 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
General disorders Chest discomfort	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
General disorders Chest pain	5.1% 2/39 • Number of events 2 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/39 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/38 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.	0.00% 0/36 • Day 28 and up to 3 months after end of study treatment Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.

Additional Information

Shin Poong Pharm. Co., Ltd.

Shin Poong Pharm. Co., Ltd.

Phone: 82-2-2189-3478

Email: bwon@shinpoong.co.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place